R&D Test Engineer
Role summary
The R&D Mechanical Engineer will be responsible for assessing the Design History File (DHF) and updating design documentation to align with the client's Quality Management System. This role involves mechanical and systems design, test method development and validation, verification testing, and statistical analysis for medical devices. The engineer will test products for feasibility, develop test methods, and conduct formal design verification testing. Key responsibilities include providing input on project goals, communicating technical progress, risks, and trade-offs to leadership, and completing clear engineering documentation. A Bachelor's degree in a relevant engineering field and at least 1 year of experience are required, with specific experience in medical device testing and DHF work.
Job Title: R&D Mechanical Engineer
Duration: 12+ Months (Possible extension)
Location: Marlborough, MA 01752
Hybrid Role
Responsibilities:
- Responsible for assessing Design History File (DHF) and updating associated design documentation and design outputs to address any gaps against the client's Quality Management System
- Utilize your background in mechanical and/or systems design, test method design and validation, verification testing and statistical analysis.
- Testing products for feasibility, test method development and formal design verification testing
- Providing input to project goals and progress and recommending appropriate revisions.
- Communicating progress, risks, and trade-offs of technical deliverables to project leadership, and recommends revisions as needed.
- Successfully completing engineering work in one or more of the following: technology development or remediation, product design refinement, test of materials, preparation of specifications, process study, and report preparation.
- Assessing the feasibility and soundness of alternative engineering processes, products, or equipment.
- Completing clear and concise engineering documentation.
- Demonstrating Technology Development and Product Development system knowledge through delivery of high quality, high impact deliverables.
Education/Experience:
- Bachelor's degree or above in Mechanical Engineering, Biomedical Engineering, Electromechanical Engineering, or related field
- 1+ yrs of engineering or related experience with bachelor’s degree
- Experience with formal testing and data logging of medical device/products
- Experience with Instron or equivalent test equipment
- Experience with mechanical testing
- Experience working on Medical Device DHF
- Strong mechanical and/or systems engineering and problem-solving skills and attention to detail
- 10% travel is possible
Preferred:
- Experience with integrations and working with cross cultural teams
- Test Method development and validation experience
- Experience in Minitab
- Experience in single-use device or medical electrical equipment System Design Verification testing and data analysis
- Familiarity with ISO 60601
#REQNon-IT
Job Type: Contract
Work Location: In person
Pay: $30.00 - $40.00 per hour
Work Location: Hybrid remote in Marlborough, MA 01752
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