Senior Mechanical Design & Quality Engineer
Senior Mechanical Design & Quality Engineer
On-site Full-time
My client is an exciting and established medical device contract manufacturer in search of a Design Quality Engineer to join their team in developing best-in-class medical device for their long standing and new clients.
RESPONSIBILITIES :
Design and Development :
- Create medical device prototypes meeting customer requirements.
- Develop test plans and oversee reporting stages.
- Manage transfer from prototype to manufacturing phase.
- Proficient in SolidWorks for engineering drawings.
- Utilize ERP system and Visual Management / Quality.
- Provide continuous support for legacy products.
- Identify cost and manufacturing efficiency opportunities.
- Troubleshoot through experimental design logic.
- Understand medical device design and IQ / PQ / OQ processes.
- Experience with assembly operations (soldering, welding, etc.).
Compliance and Risk Management :
- Adhere to ISO 13485 QMS and FDA regulations.
- Conduct risk analysis (DFMEA / PFMEA).
Leadership and Communication :
- Guide engineering team, promote team culture and improvement.
- Collaborate with Director of New Product and Business Development.
- Effective communication via reports, emails, and within the team.
Engineering Statistics :
Analyze dataset for component dimensions, tolerances, and materials.
QUALIFICATIONS :
- Bachelor’s degree in mechanical engineering or related field.
- 5+ years of design experience.
BENEFITS OFFERED :
Medical Insurance (Health, Vision, Dental).
401k with Employer matching.
Flexible Spending Account.
Employer paid life insurance.
Vacation and Sick time.
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