Growing medical device company with well documented treatment for cardiac irregularities. Challenging opportunity for a seasoned, hands-on engineer with experience designing, developing and installing process equipment for the production of disposable medical devices. The Process Development / Manufacturing Engineer is an integral part of an Operations team of Group Leaders, Engineers, Technicians, and Assemblers who work in a controlled manufacturing environment producing complex catheters and accessories. The process development / manufacturing engineer in this role will create and build equipment, tooling, fixtures, and processes required for new products, product changes and enhancements that support product throughput and quality goals. He or she will provide leadership, interface, and support for peers in other departments who contribute to the company’s success, including Quality, Materials Management, R&D, and Finance.
The position’s essential duties:
- Work directly with the Manufacturing Manager and R&D to understand new products and their associated manufacturing requirements, and develop processes to successfully transition these products to Manufacturing.
- Prove training, direction and manufacturing support to a multidisciplinary operations team.
- Work with Manufacturing Manager to assure efforts are in compliance with company SOP’s, manufacturing procedures, Quality policies, and relevant regulations (ISO, FDA, etc.).
- Review and evaluate completeness of existing pFMEA and Process Map documents. Update and/or revise as required to support FDA PMA submissions.
- Understand and interpret engineering and production drawings and procedures.
- Train assemblers to follow production drawings and procedures in:
- Production processes such as trimming, polishing, sanding, cleaning, bonding, curing, etc.
- Packaging of products in preparation for sterilization processing
- Prepare documentation including NCMR’s, ECN’s, Manufacturing Waivers, etc. in support of assembly, packaging, and sterilization operations.
- Provide leadership and support for manufacturing, sales and quality for complaint resolution, product testing, CAPA investigations and product documentation reviews (specifically including Manufacturing Procedures).
- Set up lab to test and evaluate devices at different stages of assembly.
- Formulate tests, calibrations and procedures to maintain precision accuracy of devices.
- Communicate regularly to Engineering Manager all pertinent process development activities.
- BS in an Engineering or related discipline. Significant applicable experience may also be considered in lieu of a degree.
- Minimum of seven years’ medical device experience in a manufacturing environment; experience in catheter process development and manufacturing engineering is strongly preferred.
- Solid knowledge of QSR, ISO 13485, and the MDD is critical.
- Skilled understanding and developing SOPs, engineering drawings, and manufacturing procedures.
- Ability to collect, collate, and present data effectively.
- Familiarity of LEAN principles preferred.
- Demonstrated ability to prioritize and plan work activities efficiently; set effective (SMART) goals and objectives for self and team
- Basic machine shop skills are a plus.
- Excellent English communication skills (verbal and written) required.
- Display original thinking and creativity; meet challenges with resourcefulness; generate suggestions for improving work.
- Display willingness to make difficult decisions and exhibit sound and accurate judgment.
- Show initiative by undertaking self-development activities, seeking increased responsibilities, and taking advantage of learning opportunities.