Our client is an established international company that is expanding its development and manufacture of surgical robotic devices. We are seeking a seasoned engineering manager who has proven experience leading the development, enhancement, and sustaining engineering of complex electro-mechanical medical device capital equipment. Specific, working knowledge of FDA regulations for device development is required.
The seasoned engineering leader will have responsibility for ensuring that key product development, enhancement and sustaining engineering projects are accomplished in creative and cost effective ways. The scope includes exploring and managing the redesign of certain capital equipment components as disposables, planning for and managing component optimization, obsolescence and replacement activities, and providing support for field and manufacturing engineering issues.
- Build, develop, and integrate a multi-disciplinary team of mechanical, electrical, electro-mechanical, firmware, and software engineers
- Support the product’s technical roadmap through effective resource planning, hiring, and management of engineers, designers, and technicians.
- Resolve technical issues, maintain staff engagement and focus, and share updates on project activities.
- Staff, equip and manage the engineering lab with state-of-the-art equipment, tools, and processes.
- Ensure the company is following the latest industry and FDA regulatory compliance best practices for design and development of complex medical devices.
- Provide the organization with technical expertise for development and improvement of electromechanical surgical capital equipment and disposables.
- Support on-going operations and design changes for improved manufacturing yields and throughput, cost reductions, quality improvements and actively manage end of life and part obsolescence issues.
- Coordinate with management colleagues across functions to foresee and understand critical project activities and to enable them to manage team resources and tasks to maintain critical path.
- Promote external collaborations for evaluation of technology, integration of university research, and strategic cooperation matters; to recommend products and technical layouts in line with the company’s overall strategy.
Qualifications and Skills:
- An MS in Mechanical, Electrical or Biomedical Engineering, or equivalent.
- Minimum of 15 years of Engineering Management in the medical device industry, with a proven track record of technical team building and management.
- Familiarity with systems engineering of robotic or other complex, software driven medical devices.
- Strong technical decision-making ability, project and risk management and control capabilities.
- Working knowledge of core engineering tools such as . For 6-sigma, FMEA, Risk Analysis, Process Mapping, Standard Work Instructions, Lean Manufacturing, Manufacturing Work Instruction Creation, DDOE methods, Process Characterization, V&V activities.
- Working knowledge of 21 CR 820, ISO 13485, and ISO 14971.
- Strong leadership and communication skills, with the ability to communicate effectively from the board room to the manufacturing floor
- Results orientated self-starter.