Career Opportunities for Candidates

Following are descriptions of searches Nachman BioMedical is currently conducting. We invite qualified candidates to submit resumes for confidential consideration for these and other opportunities. For additional information, or to apply for any of these positions, please contact us.

Medical Device and Instrumentation

Pharmaceutical Industry

Medical Device and Scientific Instrumentation

Research, Development and Engineering Management opportunities

Director of Engineering

The Opportunity

Exciting , early-stage Boston area medical device company that is bringing biologically-inspired biomaterials systems to the clinic to improve patient outcomes.   We seek a talented engineering manager to continue to build and lead a growing team of engineers as the company moves forward into product development. This high profile position will report to the company’s Chief Technology Officer.

The Director of Engineering will join a talented, multi-disciplinary team.  These biologists, chemists, materials scientists, and engineers are  working in close collaboration to understand the biology of disease and to create solutions that address some of today’s most challenging and critical unmet clinical needs. To support the development and implementation of its multi-functional technology platform, the company has created a state-of-the art research and development environment.

Responsibilities

• Champion technical innovation within the engineering team and in the company at large
• Create and represent a vision for the engineering group, anticipate mid- and long-term
  organizational goals and needs; drive the strategic evolution of the group to achieve this
  vision
• Oversee engineering development projects; support cross disciplinary project management
  
• Build consensus across a highly multidisciplinary, intellectually challenging organization
  
• Be accountable for high-quality, on-time delivery of engineering projects
  
• Define and implement engineering standards, and progressive operating procedures
  
• Discover, define, and articulate engineering requirements for implantable medical devices
  
• Develop and manage engineering budgets

Qualifications

• A highly-motivated manager who can coach and develop people, formulate and implement
  strategy, and plan and execute tactically
  
• A leader who can work closely with senior management to align priorities and create a sense
  of urgency to ensure successful endpoints are achieved and timelines are met
  
• Experienced in engineering project management, and able to establish and communicate
  project plans that enable effective cross-disciplinary development
  
• Experienced in the design and development of medical devices
  
• Able to quickly establish credibility with smart engineers and scientists
  
• Able to grow your team’s capabilities through mentorship, management, motivation, strategic
  hiring, appropriate outsourcing, and visionary leadership
  
• Comfortable working and communicating effectively in a cross-functional, highly
         interdisciplinary environment
  
• Entrepreneurially driven, looking to work in an extremely dynamic and fast-paced               
         environment, and prepared to meet aggressive development milestones
  
• Skillful in the management of scarce resources—time, personnel, and money
  
• Excited about having impact within and beyond your team

 Requirements

• 5-10+ years of relevant experience in the management of design engineers and technicians.
• 5+ years of relevant hands-on technical experience, a record of individual technical    
  achievement, and a strong academic record
• Desire for a leadership career which offers the opportunity to remain technically hands-on
• Project management skills and a proven track record for product delivery
• Outstanding verbal and written communication skills
• Launched multiple products to market, including catheter-based delivery systems and
  implants; combination product experience preferred
• Robust knowledge of FDA QSR and ISO regulations
• Extensive pre-clinical study experience
• BS in Mechanical or Biomedical Engineering; MS preferred.

Manager/principal mechanical engineer

Growth opportunity at a promising early stage surgical device and robotics company with exciting technology and strong market opportunity.

Summary:
Excellent career opportunity for a hands-on Manager or Principal Mechanical Engineer with significant, successful experience in the design of surgical instruments and complex mechanisms.  This seasoned engineer will have a lead role developing, documenting, and validating new product designs for the company’s surgical robotic products, as in improving existing designs to meet the needs of customers.  He or she will work with a terrific team of highly experienced and motivated medical instrument development, motion control, and surgical robotics experts creating a new generation of easy to use systems for precise surgery.

   
Responsibilities:

• Design and adapt surgical instruments for robotics interface
• Design and develop major mechanical assemblies, subsystems and components for robotic surgical systems
• Lead a team of internal and external resources to complete complex designs
• Create IP to support the company’s long-term goals.
• Identify and direct vendors to modify, enhance their technologies to integrate more fully into the designs
• Investigate clinical requirements and produce subsystem specifications
• Support production by troubleshooting process and component problems.
• Train sales, marketing professionals on technical aspects of designs being created

Requirements:

• BSME required, MSME preferred
• 8 - 20 years experience designing and developing mechanically based medical devices,  medical instrumentation, and/or robotics.
• Proven ability to create and deliver subsystems that consider the mechanical aspects as well as other disciplines (SW, HW, industrial design, etc.)
• Track record bringing multiple designs to production, with focus on DFM and reliability.
• Proven capability to lead multi-person teams comprised of internal and external resources in design / development of complex mechanisms, ideally for motion control
• Injection molding and plastics design experience
• Able to mentor junior engineers and technicians
• Experience in a start-up environment is highly desired.
• Knowledgeable in all phases of the product development lifecycle including feasibility, design input creation, verification, qualification, and transfer
• Proficiency with CAD, ProE and/or SolidWorks preferred

Senior Hardware Engineer

Challenging senior opportunity at a growing medical device company that designs, develops and sells proprietary instrumentation used to diagnose diseases and injuries.  The Senior Hardware engineer will have the opportunity to specify and perform analog and digital design, and create project schedules.  This  highly visible role reports to the Senior Vice President of Engineering. 

This Boston area company is at exciting point in its development – multiple products are FDA approved and on the market, with more in the product development pipeline, including drug delivery devices.  Its handheld instrumentation system combines advanced technologies to provide MDs with objective information that aids in rapid and accurate diagnosis at the point of care.

Responsibilities:

• We seek an experience, talented electrical engineer with expertise in the design and development of embedded control hardware.
• The Senior Hardware Engineer will participate in defining functional requirements for new products and translate these into technical specifications. 
• Responsibility includes providing project scheduling, task breakdowns, and evaluating resource requirements. 
• Support documentation and validation efforts, and follow company policies regarding ISO and FDA compliance.

Experience

A minimum of 5 years experience in analog and digital hardware design, with significant exposure to the full cycle of commercial product development.  A medical instrumentation background is preferred.

Required Skills

Analog and digital circuit design 
Experience with microcontrollers and component communication protocols such as SPI, I2C.
Experience with circuit analysis and circuit layout tools.
Embedded software experience for hardware control is a big plus
Proven track record in working with real-world engineering constraints
Project management skills
Excellent communication skills
Experience with hand-held products is very desirable

Education

A B.S. in electrical, computer science, biomedical engineering, or a related engineering field.  An MS is a  plus.

Senior Electronics engineer

Summary:

Advanced cardiac device company with well received technologies for treating heart failure has an opportunity for an experienced, high performing medical electronics hardware engineer.

The Senior Electronics Engineer will be responsible for the circuit designs of electronic devices in support of implantable cardiac devices.

• Primary design responsibilities for the electronics design and early stage prototype software for external electronic devices
• Responsible for preparation of design specifications and component procurement
  specifications
• Component and subsystem level characterization tests
• Interface with suppliers
• Support verification activities

Requirements:

BS or MS in Electrical Engineering

5 -10 years in medical device electrical engineering design

The appropriate candidates must have:

• New product development experience in the medical devices
• Digital circuit design
• Experience with 8, 16 & 32-bit embedded microcontrollers – hardware architecture  
  and writing embedded software design in C
• Experience with schematic capture, PCB layout, and circuit simulation
• A structured approach to development,
• Practical understanding and experience working with design controls, and quality
  system regulations
  

• Mixed signal circuit design, FPGAs
• Experience in implantable medical devices
• Design of RF communications
• Battery Experience – power management.
• Motor Control
• Ability to manage projects and work effectively with vendors

Senior compliance engineer

Well established, profitable, global medical device company has an interesting opportunity for a strong compliance and reliability engineer.  The company is a leader in the design, manufacture and worldwide sales and marketing of medical capital equipment and related disposable devices in critical markets.

RESPONSIBILITES

• Senior opportunity, with responsibility for development and implementation of strategies to secure national and international safety and efficacy certifications (UL, cUL, CE in accordance with MDD, JIST, etc.) for all new and existing hardware products.  Provide engineering guidance in the application of these standards.
• Contribute to the design, development and support of systems and components for a variety of medical device development projects. 
• Actively contribute in early stages of new product development, and in changes to existing devices. 
• Contribute to product validation testing and safety agency testing including Software, Hardware and EMC.  Participate in Risk Assessment activities.

QUALIFICATIONS:

• Minimum of BS in Electrical, Software or Biomedical Engineering. 
  5 plus years proven experience in securing various safety certifications such as UL, cUL, CE (in accordance with MDD and EMC) for medical devices. 
• Experience in medical product development
• Good communication skills.

Senior r&d Systems v&v Test engineer

Well established, profitable, global medical device company has a challenging opportunity for a systems oriented validation and verification engineer.  This company is a leader in the design, manufacture and worldwide sales and marketing of capital equipment and related disposable in critical markets.

Responsibilities:

The selected candidate will perform technical V&V planning, system integration; cost and risk, supportability and effectiveness analyses for total systems. This encompasses concept, design, fabrication, test, installation, operation, maintenance and disposal.   Ensure the logical and systematic conversion of customer or product requirements into total systems solutions that acknowledge technical, schedule and cost constraints.  Perform functional analyses, timeline analysis, detail trade studies, requirements allocation and interface definition studies to translate customer requirements into HW and SW specs.  

• Develop System V&V Plans, System Test Plans, Protocols, and Test Cases
• Plan, execute, and document System V&V activities
• Develop system and subsystem  requirements, performance, interface, and test specs
• Develop and document Systems Architecture of devices and systems across all disciplines
• Prepare technical descriptions of systems and subsystems
• Review overall system technical concepts of designs
• Participate in solving system-level technical problems (HW, SW, mechanical, disposables)
• Stay current with applicable regulatory standards
• Help develop and maintain Systems V&V SOPs, Work Instructions
• Provide support to manufacturing and service organizations
• Mentor and coach to more junior engineers / technicians
• Continuously improve through classes, further education, self-study, on-the-job training, etc.

Qualifications:

• BS or equivalent experience and training in systems, computer, EE, mechanical or biomedical engineering
• 5 years relevant experience (with at least 3 years Systems V&V experience in an FDA-regulated environment), or equivalent combination of education and experience

• Working knowledge of systems integration, electronic circuits design, real-time software development, mechanical and disposables design desirable
• Experience with medical device development under FDA QSR Systems Regulations, CE Marking, and ISO-9000 Quality Systems desirable
• Familiarity with Industry Best Practices in engineering
• Effective writer; able to articulate complex technical concepts  in an easily understand manner
• Customer focused; strong oral communication and interpersonal skills
• Able to interact effectively with the full spectrum of engineering personnel and vendors

embedded software engineers / medical diagnostic devices

Challenging software opportunity at an innovative medical device company developing diagnostic test systems for the physician’s office – the place where we receive most of our healthcare.  Our client has pioneered a high quality, low cost system designed to improve patient care by delivering real-time test results to the physician during the patient’s office visit.  The Embedded Software Engineer will make important contributions to this leap forward in delivering more efficient and timely healthcare, and will create a new standard.  Rapid, reliable test results are linked and distributed to a centralized data management system that also performs validation - all via a secure internet portal.

Responsibilities

The Embedded Software Engineer is a hands-on technical role, developing software while complying with FDA documentation and development practices and requirements traceability.

• Work with a set of specifications (System/Software Requirements, Software Architecture, Software Detailed Design and Software Interface) to produce software components of a product.
• Contribute to the design and development of a software error detection and recovery philosophy.
• Contribute to the identification of software-related risk areas and develop mitigation plans.
• Participate in architecture reviews, design reviews, and code reviews.
• Implement product components based on product architecture and design specifications.
• Contribute to the production of software test procedures for product testing.
• Develop other associated technical documentation as required, according to standards established by regulatory bodies and the eventual users 
• Contribute to the development of a system test plan identifying test criteria and methods to ensure successful performance consistent with product requirements and specifications.

Qualifications

• BS or MS in Computer Science or Electrical Engineering
• Minimum twoto five years experience, depending on the exact role
• Strong C# programming skills, in the .NET environment is required
• Successful, hands-on experience with high-criticality, embedded system real time architecture 
• Background developing real-time, multi-threaded applications
• Experience in OOA/OOD/OOP applications
• Experience with Windows CE platform applications is helpful
• Good troubleshooting skills 
• Exposure to Microsoft Visual studio and Microsoft SQL database is a plus
• Familiarity with source code control (configuration management) systems such as Clear Case, Visual Source Safe, CVS is a plus 
• Familiarity complying with FDA regulations; experience developing software under FAA or DOD regulations would also be considered
• Ability to interface professionally at all levels with internal personnel and external development partners
• Excellent written and verbal communications skills

plastics disposables development engineer

Excellent career opportunity to join an innovative start up medical device company with an advanced technology platform and products.  The Plastics Disposable Development Engineer will work collaboratively to develop high quality, low cost systems designed to revolutionize patient care by providing real-time patient test results to the physician during the patient’s clinical visit.  This new standard of healthcare includes advanced instrumentation, reagents, and sophisticated plastic disposables.  The test results are linked and distributed to a centralized data management system that also performs validation via a secure internet portal.

Responsibilities

Work closely with colleagues and external resources, and make hands on contributions.

• Design, prototyping, testing and analysis of fluidic concepts for plastic disposable devices used for blood collection, sample preparation and in-vitro diagnostic assays.
• Integration of these concepts into an overall design of precisely molded plastic disposable parts with microfluidic paths.  These parts will meet the performance requirements and constraints associated with high-volume plastics manufacture, and manufacturing cost targets.
• Undertake general engineering tasks as a member of the development team.
• Provide technical reports that document design history and recommend next steps.
• Specify assembly techniques of plastic disposables

Qualifications

• BS or MS in Plastics, Mechanical Engineering, or Biomedical Engineering
• 3-8 years of industry background developing high volume disposable, molded plastic devices.  Class II or III medical device background is preferred. 
• Strong mechanical design and prototyping skills. 
• Practical experience with CAD (SolidWorks or similar systems) 
• Excellent communication skills, as well as the ability to interact with a diverse interdisciplinary team.

mechanical engineer

Well established, profitable, global medical device company has an interesting opportunity for a creative mechanical engineer.  This successful company is a leader in the design, manufacture and worldwide sales and marketing of medical capital equipment and related disposable devices in a critical markets.

RESPONSIBILITIES
The Mechanical Engineer will contribute his or her talents in a number of ways:

• Responsible for ongoing development and engineering support of complex electromechanical medical devices, and creation of product enhancements for a worldwide customer base. 
• Support all aspects of design/development of new products.
• Work closely with groups or departments to identify and correct design problems during developmental cycle. 
• Design and execute tests to verify functionality and develop/document test protocols/test reports according to SOP. 
• Design/build prototype test fixtures and assist in development of test procedures.  
• Review and update product specifications.
• Work to insure new equipment can be easily assembled
• Work with Field Service and assist in training for assembly and service on new equipment.

 
QUALIFICATIONS

• BS in Mechanical Engineering
• 3-5 years professional experience in a medical device environment or other regulated industry 
• Analytical strength
• Modeling/​Design Experience
• Self Starter with willingness to learn
• Ability to use Solid Works and Auto CAD preferred.​ 
• Must know Excel and Word
  

Quality, Regulatory, Clinical Studies and related Management opportunities

VP / Director of Clinical and Regulatory Affairs

Growing, early stage medical device company which has developed a unique robotic system to be used during percutaneous procedures in the cath lab, such as angioplasty. The company is establishing a new standard for the physician safety and quality of life, workflow efficiency, and improved patient outcome in a fast growing, $7.5B market.

The VP/Director of Clinical and Regulatory Affairs is responsible for international and domestic clinical and regulatory activities for the system. Initial responsibilities will be focused on executing 510(k) approval in the US and CE mark in Europe.

Responsibilities

• Strategic planning: Along with senior management team, sets direction for clinical studies and regulatory filings, defines objectives and outputs; and determines the cost, schedule, priority to accomplish objectives.
• Project management: For each Clinical trial or filing, assures that it’s planning and execution is managed effectively and efficiently, on schedule, and within budget. Responsible for internal and external communication of Clinical data to stake holders. Oversees compliance of Sponsor/Investigator/Monitor responsibilities to protocol, case report forms completion, and ICH GCP guidelines
• Relationship management: Along with senior management team, establishes and manages positive relationships with key clinical investigators, clinical research contract service providers, medical institutions, leaders of medical conventions, professional societies, etc.
• Department management: Build and lead a small but dynamic staff to execute Clinical and Regulatory objectives.
• Clinical trial management: lead the company activities in these fields towards a CE and FDA approval.

Qualifications

• A minimum of 8-12 years clinical research or regulatory experience with Class II or III medical devices. Greater experience is a plus.
• Successful experience designing, executing, analyzing, and presenting the results of medical device clinical trials.
• Successful experience interacting with domestic and international regulatory authorities.
• Strong knowledge of good clinical practice (GCP) and regulatory compliance guidelines. Proficient in running multi-site clinical studies (domestic and international).
• 2-5 years in Cardiology. working knowledge of anatomy, disease states, Cath Lab interventional procedures
• Education: MS/PhD/MD preferred in a scientific discipline (i.e., medical/scientific field, biological science, RN with significant experience).
• Skill in managing multiple fast-paced and high-demand projects, successfully balancing scope, schedule, and cost.
• Outstanding verbal and written communication skills to interact successfully with physicians, service providers, and senior management and staff.
• Must be adept at delegation, follow-up, and team building.
• Able to travel up to 30%.

Quality Assurance Manager

Excellent QA career opportunity at a compelling, venture capital backed medical device company with a leadership position in applying powerful imaging techniques to medical applications. Its FDA approved device can differentiate between healthy and diseased tissue, radically improving both diagnosis and therapy for patients with diabetic foot ulcers and peripheral arterial disease. The Quality Assurance Manager will be responsible for developing and managing an operational Quality system.  He or she will oversee Quality inspection of processes and products,  and will assure and certify product compliance. This highly visible opportunity reports to the VP, Clinical Research and Regulatory Affairs.  The person selected for this position will have the unique opportunity to be part of a leadership team building a market for the next generation of medical devices that ultimately improve patient care.  Future research will apply the technology to improving diagnosis of breast cancer, congestive heart failure, shock, and burns. 

Responsibilities

We are seeking a seasoned, highly effective medical device or diagnostics quality professional who will:

• Drive product Quality Improvement initiatives, contribute to change control planning for product improvements
• Help facilitate continuous improvement and learning across all functional areas through   training and communication of quality initiatives
  
• Contribute to Process and Design / FMEA Reviews
  
• Contribute to inspection requirements including incoming, in process and final inspections
• Management Representative for ISO-13485 Quality Management System
  
• Manage Complaints and Corrective Actions
  
• Manage Noncompliant Materials and Suppliers
  
• Participation in Supplier and Internal Audits
  
• Manage the Calibration System
  
• Manage Document Control

Qualifications

• Minimum BS in engineering with 5 years medical device quality engineering experience with disposables, software and electronics
• Thorough working knowledge of FDA quality regulations and ISO 13485
• Strong engineering skills with a working knowledge of process validations and verification activities. 
  
• Ability to define problems, collect data, establish facts and draw conclusions.
• Problem solving techniques including root cause analysis and cause and effect analysis
• Ability to effectively present information in one on one and small group situations.
• Excellent interpersonal, analytical and organizational skills.
• Excellent written and verbal skills.

Senior compliance engineer

Well established, profitable, global medical device company has an interesting opportunity for a strong compliance and reliability engineer.  The company is a leader in the design, manufacture and worldwide sales and marketing of medical capital equipment and related disposable devices in critical markets.

RESPONSIBILITES

• Senior opportunity, with responsibility for development and implementation of strategies to secure national and international safety and efficacy certifications (UL, cUL, CE in accordance with MDD, JIST, etc.) for all new and existing hardware products.  Provide engineering guidance in the application of these standards.
• Contribute to the design, development and support of systems and components for a variety of medical device development projects. 
• Actively contribute in early stages of new product development, and in changes to existing devices. 
• Contribute to product validation testing and safety agency testing including Software, Hardware and EMC.  Participate in Risk Assessment activities.

QUALIFICATIONS:

• Minimum of BS in Electrical, Software or Biomedical Engineering. 
  5 plus years proven experience in securing various safety certifications such as UL, cUL, CE (in accordance with MDD and EMC) for medical devices. 
• Experience in medical product development
• Good communication skills.

Biostatistician / Statistician

Would you like to advance your biostatistics career while making significant contributions to the development of innovative, clinically significant products? Expanding, Boston area company has created a class of non-invasive, point of care diagnostic devices that provide physicians with immediate and cost-effective clinical information for timely diagnosis and treatment of conditions associated with certain specific injuries, and systemic diseases. The company is at exciting point in its development - multiple products are FDA approved and available in thousands of physician offices around the US, and additional innovations are in the development pipeline.

Responsibilities

The company’s active product development programs and clinical research activities have created an excellent opportunity for a creative statistician to analyze data obtained during product development phases, through clinical trials and post product deployment. This is challenging opportunity for a statistician to be responsible for ascertaining proper statistical techniques necessary to determine the efficacy and robustness of medical devices that incorporate advanced signal processing for their results. The successful candidate will also be responsible for implementing these techniques, carrying out the analysis and presenting the results. He or she will work as an important part of a product development team comprised of multi-disciplinary engineers and clinicians.

Requirements and Qualifications

• Strong statistical and mathematical background
• MS in biostatistics or statistics, MPH with a biostatistics focus, or a technical field with strong statistical coursework
• Proficient with MATLAB
• Experience applying statistical techniques to large, clinical data sets
• Ability to fluently communicate techniques and results to non-experts
• Proven ability to incorporate results into peer-reviewed publications
• Ability to work with clinicians, and an experienced SW, HW and biomedical engineering team
• Ability to work with independently

Marketing Management, Sales Support/Applications and Customer Training

Medical Instrumentation Applications, customer training, clinical specialist

The Company

Exciting, young medical instrumentation company with strong product and platform technology.  Our client has created very high definition real-time intravascular imaging systems with primary applications in the cardiovascular arena.  The system consists of sophisticated instrumentation, optics and a disposable catheter/probe/balloon set. 

The Opportunity

• Be a key company contact for interventional cardiologists and nurses for product technical applications and clinical support 
• Work with MDs researchers in application of the product to their needs for realtime diagnosis of disease     
• Perform installations, training and demonstrations of equipment in the cathlab and OR.
• Train customer on new features or enhancements made to existing features
• Provide technical support to the company's sales force
• Support clinical trials, animal studies and trade show activity
• Act as a liaison for customers to the company's sales and engineering departments
• Provide feedback from the field to improve processes and improve efficiencies.
• Perform related administrative duties, such as Field Activity Reports, Expense Reports

Requirements

• Professional experience working as a medical device instrumentation field applications or sales support specialist, or cardiovascular technician, or Cath lab nurse or technologist.  A medical instrumentation product development engineer with significant field and customer applications and support experience would also be considered. 
• BS Nursing, Life Sciences, Biomedical, Electrical or Mechanical Engineering
• Familiarity with cath lab and OR protocols, medical terminology
• Knowledge of cath lab and OR equipment is a plus
• Able to work independently in a fast paced environment with little supervision

Manufacturing Engineering

Senior Advanced Manufacturing Engineer
 
Exciting, early-stage medical device company that is bringing biologically-inspired biomaterials
systems to the clinic to improve patient outcomes. Key position reporting to the VP, Engineering.
Located within a state-of-art R&D facility in suburban Boston.  Work in close collaboration with a multi-disciplinary team of engineers, materials scientists, biologists, chemists to understand the biology of disease and to create solutions that address some of today’s most challenging and critical unmet clinical needs.

Experience

• Skilled at developing and implementing reliable processes and procedures for manufacturing, assembly, packaging and sterilization of medical devices
• Experienced in organizing and setting up pilot manufacturing operations
• Comfortable working and communicating effectively in a cross-functional, highly
  interdisciplinary environment
• Excited about having impact within and beyond your team
• Looking to work in an extremely dynamic and fast-paced environment, and you are
  prepared to meet aggressive development milestones
• A highly self-motivated problem-solver and self starter.

Responsibilities

• Responsible for organizing, managing and establishing the company’s prototype
  assembly and pilot manufacturing operations
• Planning and coordinating the work of a team of engineers and technicians to create
  prototype devices
• Managing and providing leadership and feedback to your team members.
• Using input from co-workers to define the assembly requirements and developing plans
  to meet target milestones
• Implementing creative ways to improve process efficiency and throughput
• Providing Design For Manufacturability (DFM) expertise to project teams to ensure
  robustness and manufacturability of the company’s product designs
• Providing guidance and oversight in the design and procurement of tooling and fixtures
• Working with QA to establish and document ISO/FDA compliant procedures for the
  manufacture, storage and distribution of the company’s products
• Managing supplier relationships and inventory levels

Qualifications

• B.S. degree in engineering
• Minimum 5 years experience in the development of manufacturing process for disposable medical devices; experience in manufacturing products under ISO 9000/GMP procedures is expected
• Experience and knowledge of processes for production of catheters and implants; experience with coatings and/or combination products a plus
• Working knowledge of Design Control procedures, process validation activities and experience in qualifying processes for PMA products is expected
• Team player with excellent written and verbal communication skills

Operations

Senior Advanced Manufacturing Engineer
 
Exciting, early-stage medical device company that is bringing biologically-inspired biomaterials
systems to the clinic to improve patient outcomes. Key position reporting to the VP, Engineering.
Located within a state-of-art R&D facility in suburban Boston.  Work in close collaboration with a multi-disciplinary team of engineers, materials scientists, biologists, chemists to understand the biology of disease and to create solutions that address some of today’s most challenging and critical unmet clinical needs.

Experience

• Skilled at developing and implementing reliable processes and procedures for manufacturing, assembly, packaging and sterilization of medical devices
• Experienced in organizing and setting up pilot manufacturing operations
• Comfortable working and communicating effectively in a cross-functional, highly
  interdisciplinary environment
• Excited about having impact within and beyond your team
• Looking to work in an extremely dynamic and fast-paced environment, and you are
  prepared to meet aggressive development milestones
• A highly self-motivated problem-solver and self starter.

Responsibilities

• Responsible for organizing, managing and establishing the company’s prototype
  assembly and pilot manufacturing operations
• Planning and coordinating the work of a team of engineers and technicians to create
  prototype devices
• Managing and providing leadership and feedback to your team members.
• Using input from co-workers to define the assembly requirements and developing plans
  to meet target milestones
• Implementing creative ways to improve process efficiency and throughput
• Providing Design For Manufacturability (DFM) expertise to project teams to ensure
  robustness and manufacturability of the company’s product designs
• Providing guidance and oversight in the design and procurement of tooling and fixtures
• Working with QA to establish and document ISO/FDA compliant procedures for the
  manufacture, storage and distribution of the company’s products
• Managing supplier relationships and inventory levels

Qualifications

• B.S. degree in engineering
• Minimum 5 years experience in the development of manufacturing process for disposable medical devices; experience in manufacturing products under ISO 9000/GMP procedures is expected
• Experience and knowledge of processes for production of catheters and implants; experience with coatings and/or combination products a plus
• Working knowledge of Design Control procedures, process validation activities and experience in qualifying processes for PMA products is expected
• Team player with excellent written and verbal communication skills

Purchasing and materials management specialist/manager
 
Ground floor purchasing and materials management opportunity in the medical device industry.  Emerging implantable medical device manufacturer with devices for improved surgical repair of a common injury. 
           
Responsibilities

• Select and manage suppliers and purchases to ensure best prices and contract terms, timely delivery, and a high level of quality for all parts and supplies. Materials and inventory include custom reusable surgical instruments and components to be assembled internally into long-term implants.
• Manage the inventory of parts and supplies and place orders so that items are available when needed, without carrying excessive inventory levels.
• Keep team informed of cost advantages, product availability, market trends, vendor and item changes, and related information and anticipate and advise management of potential supply chain problems which may have significant impact on business.
• Assist Quality Department with supplier evaluation/qualification to ensure they meet company requirements.
• Serve as a liaison between company personnel and supplier representatives.
• Assist Finance Department with financial analysis to evaluate make/buy alternatives and lease/buy options and participate in value engineering efforts.
• Work with internal departments to develop purchasing policies and practices which promote cost minimization and timely availability and ensure compliance.
• Work with Finance Department to generate and record purchase orders, receive goods and match to invoices, ensuring accuracy in all steps.

Critical Knowledge, Skill and Abilities:

• Demonstrated skilled negotiator with working knowledge of contract terms and conditions and ability to locate multiple supply sources and manage inventory and spare parts levels.
• Good organizational skills, strong attention to detail, and ability to prioritize tasks within a busy environment as well as solve problems and act independently.
• Able to interpret industry and financial data and make business decisions based on this data and to perform basic mathematical calculations on a regular basis.
• Proficiency with Microsoft Office (Word, Excel, PowerPoint, Outlook) required.
• Knowledge of database software (MS Access) or inventory management software (SAP) a plus.
• Excellent written and verbal communication skills.

Experience/Education:

• Minimum 4-6 years experience in a procurement role within the medical device industry, with direct responsibility for managing vendors and negotiating contracts.
• BA/BS in Business or Supply chain preferred, but not required.

Pharmaceutical Industry

Research and Development

Please check back in soon for new opportunities.

Process Engineering

Please check back in soon for new opportunities.

Manufacturing Compliance

Please check back in soon for new opportunities.

Contact us for more information or to apply for any of these positions.