Baltimore, Maryland | Direct Hire
Trimech Services is a boutique engineering staffing firm that specialized in finding top level product and machine design and engineering professionals for our clientele. Our current client is an innovative medical device startup. Their aim is to develop the next generation compact ECMO that will transform clinical practice and improve quality of life for those who suffer from acute and chronic lung problems. Currently, we are working on filling the following opening for this client:
Mechanical Engineer (Medical Device Design)
As a member of the technical staff, the engineer is responsible for the design of new products up to full production. This includes specification reviews, development program timelines and reports, design reviews, simple mechanical designs, documentation packages, preproduction builds and transfers to production.
- Medical device design and process development of an in-home-use mobile medical device (MMD).
- Product Design: Utilize commercial CAD software, SolidWorks preferred (Pro/E, Autodesk Inventor or close SolidWorks type) to complete the design of plastic injection design molded parts.
- Process Design: Design the processes for the manufacture of an MMD
- Verification: Bench test prototype MMD performance against computational results.
- DHR/DMR: Generate the beginnings of the Device History Record and Device Master Record.
- Design Controls: Conduct all engineering work following FDA design controls. Generate and maintain product requirements and specifications per FDA design controls.
- Validation: develop test methods, conduct and document verification and validation activities in support of Regulatory submissions.
- Strong collaboration, communication, and team work skills.
- Previous experience designing blood-contacting medical devices.
- Background/previous experience with coatings for blood-contacting medical devices.
- Strong base of mechanical engineering knowledge.
- Strong analytical problem solving skills.
- Experience in design release to manufacturing.
- Previous experience in medical device, automation/sample prep system, and/or analytical instrument development preferred.
- Practical experience with adhering to Design Controls in ISO 9000/ISO 13485 environments preferred.