Why this role stands out
This hybrid Product Development Engineer role offers a fantastic opportunity to contribute to innovative medical device development within a reputable company, with a competitive salary of $85,000-$100,000. You'll thrive if you have a strong engineering background and 3-5 years of experience in FDA/ISO regulated environments, eager to deepen your skills in design controls and risk management. Apply today to advance your career in a dynamic and supportive setting.
Quick overview
Job description
This a full-time permanent role with competitive salary + bonus and benefits like 401k match, dental, vision etc.
This job will have the following responsibilities:
- Conduct product design control activities for both new product development and sustaining engineering projects.
- Support risk management activities, including Design Failure Mode and Effects Analysis (DFMEA) and Process Failure Mode and Effects Analysis (PFMEA).
- Design Verification (DV)
- Design Validation (PV)
- Software Validation
- IQ/OQ/PQ (Installation Qualification, Operational Qualification, and Performance Qualification)
- Design History Files (DHF)
- Technical Files
- Design specifications
- Verification and validation documentation
Qualifications & Requirements:
- Bachelor's degree in Engineering, Science, or a related technical discipline.
- Electrical Engineering degree preferred.
- 5+ years of experience in the design and development of Class II electro-mechanical medical devices.
- Experience working within FDA-regulated and ISO-compliant medical device environments.
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Contact:
This job and many more are available through The Judge Group. Please apply with us today!
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