Design Engineer
$100,000–$100,000 year
On-site · Union City, California, United States
Union City, California, United StatesOn-siteFull Time$100,000–$100,000 yearMid LevelBachelors DegreeUnknown
Type
Full Time
Level
Mid Level
Education
Bachelors Degree
Company size
Unknown
Job Summary
Design Engineer to develop and validate medical device designs from concept through launch, leading cross-functional teams, performing FEA and DOE analyses, creating engineering drawings and prototypes, ensuring regulatory compliance with FDA 21 CFR Part 820 and ISO 13485, and mentoring junior engineers.
Required Qualifications
- Bachelor of Science in Mechanical Engineering, Biomedical Engineering, or Materials Engineering (or related science/engineering area)
- 3-5 years of experience developing medical products
- Experience with metals or reusable surgical instruments is a plus
- SolidWorks proficiency and CAD to create detailed 3D models and engineering drawings; CAD proficiency in PDM environments
- Experience creating rapid prototypes and mock-ups, and evaluating designs via testing and rigorous analysis
- Strong problem-solving skills with systems-level thinking; ability to interface between design teams
- Excellent interpersonal and communication skills, both written and verbal
- Familiar with design lifecycle phases including conceptualization, verification, validation, and transfer to manufacturing
- Technical writing proficiency
- Able to travel 10-20% of the time
- Location: Union City, CA
- Direct Placement (full-time)
- Compensation: $100,000
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