Sr. MedTech Process Engineer

Job DescriptionJob DescriptionThe Opportunity

This is an opportunity to serve as a Senior Process Engineer at a well-funded, mission-first medical device company developing an AI-powered intravascular ultrasound platform to improve patient imaging and dramatically affect care for health conditions that affect 200 million people globally. We are looking for someone to join our San Jose based team to help lead Process Engineering for R&D designs within a low volume manufacturing line all the way through commercial release at high volumes.

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

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