The Senior Engineer will lead the optimization, validation, and lifecycle support of heart valve manufacturing processes across Surgical, Transcatheter Heart Valve (THV), and Transcatheter Mitral & Tricuspid Therapies (TMTT) product lines.
How you'll make an impact:- Provide technical ownership of valve assembly manufacturing processes, equipment, and product quality.
- Lead complex process improvement initiatives to improve yield, quality, ergonomics, throughput, and labor efficiency.
- Drive manufacturing investigations, NCRs, CAPAs, and root cause analyses using structured problem-solving methods.
- Develop, execute, and document process validations and equipment qualifications (IQ/OQ/PQ).
- Support commercialization, design transfer, and scale-up of new valve products and manufacturing technologies.
- Assess manufacturing risks and implement sustainable corrective and preventive actions.
- Partner with cross-functional teams, including Operations, Quality, Regulatory, Supply Chain, and R&D, to resolve complex technical issues, drive project execution, and develop scalable manufacturing processes that support product quality, regulatory compliance, operational efficiency, and successful product launches.
What you'll need:- Bachelor's degree in engineering or scientific with 4 years of manufacturing experience in a highly regulated environment.
- On-site presence required to effectively collaborate cross-functionally, and support manufacturing operations.
What else we look for:- Master's degree; MBA, Mechanical, or Biomedical degree.
- Lean or Black Belt certification.
- Class III medical device manufacturing experience.
- Strong technical skillset in manufacturing engineering: design for manufacturability (DFM), EH&S guidelines, FDA guidelines, and process validation.
- Experience leading scale-up and manufacturing implementation projects.
- Effective communication and interpersonal skills at all levels of employees, suppliers, and consultants.
- Excellent documentation, communication, and interpersonal relationship skills including negotiating and relationship management.
- Advanced problem-solving, organizational, analytical, and critical thinking skills.
- Proven expertise in MS Office Suite.
Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families.
For California, the base pay range for this position is $108,000 - $153,000 in tool (highly experienced).
The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will be accepted while this position is posted on our Careers website.
