Location
Tracy, CA | United States
Job description
The Opportunity
This is an opportunity to serve as a Senior Process Engineer at a well-funded medical device company developing a novel AI-based platform to treat a cardiovascular disease that affects 200 million people globally. We are looking for someone to join our North San Jose based team to lead everything from process development through optimization and validation for our devices within low volume manufacturing lines through high volume commercial release.
At a higher level, you could help dramatically affect care in the biggest and fastest growing patient need for our technology’s use case. This is an opportunity with a lot of growth and impact potential.
Potential Responsibilities
You will be responsible for developing, implementing, optimizing, testing, and validating processes for our medical device products. This can include:
- Participating in the creation and review of product process development objectives.
- Developing, implementing, & optimizing improved engineering and manufacturing processes.
- Identifying and developing technical specifications, drawings, and process specifications.
- Performing design reviews and pre-validation assessments to identify processes to improve.
- Troubleshooting and improving production when failures occur and/or yields fall below targets.
- Participating in the review of equipment, fixtures, and tooling; and implementing improvements.
- Owning processes that may include lapping, milling, dicing, and bonding.
- Writing and reviewing process instructions and training support staff.
- Investigating non-conforming materials and recommending corrective action plans for discrepancies.
- Leading process validation activities (DOE, Gage R&R, IQ, OQ, and PQ) in cooperation with quality engineering.
- Participating in pFMEA’s, process validations, and verifications.
- Utilizing accurate metrology and statistical methods for process improvements; experience with Geometric Dimensioning & Tolerancing (GD&T).
- Experience with design for manufacturability, tolerance analysis, cost analysis, and working with engineering drawings meeting quality standards.
- Maintaining design control in compliance with QMS.
- Working knowledge of FDA quality system regulations, GMP, and ISO 13485 requirements.
Preferred Qualifications:
- B.S. or higher in an Engineering, technical, or related field
- 4+ years of hands-on industry experience
- Medical Device experience is a plus
We encourage applications from candidates of all backgrounds and experiences, even if you don't meet every qualification listed. If you believe you can excel in this role and contribute to our team, we encourage you to apply. Your unique perspective may be exactly what we need.
Base Salary Range:
$165,000 - $180,000
Job tags
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