Product Development Engineering Manager

Duke Empirical is now Cordica Medical!

Cordica Medical is a mission‑driven medical device company dedicated to advancing patient care through thoughtful innovation and clinical excellence. We specialize in developing and commercializing technologies that address meaningful unmet needs, with a focus on improving outcomes, efficiency, and quality of life for patients and providers alike.

Our team brings together experienced professionals from clinical, engineering, regulatory, and operational backgrounds who share a commitment to integrity, collaboration, and impact. At Cordica Medical, every role contributes directly to our purpose—translating smart ideas into practical solutions that make a real difference in healthcare.

If you’re looking to grow your career in an environment that values accountability, curiosity, and teamwork, Cordica Medical offers the opportunity to do meaningful work while helping shape the future of medical technology.

Cordica Medical, Morgan Hill, California is seeking a Product Development Engineering Manager. The Product Development Engineering Manager leads the product development team and is responsible for both internal and customer projects from pilot to manufacturing transfer. The position manages a technical team of engineers and product assemblers and coordinates cross-functional activities with technical sales, quality, procurement, production, and customers. The Product Development Engineering Manager will comply with supervisory responsibilities in accordance with Cordica Medical policies.

Duties

• End to End project leadership for internal and customer development projects. Including planning and execution of projects under Cordica Medical design control or customer design control.
• Drive on-time, in-scope, and in-budget outcomes.
• Product transfer from development to manufacturing. Including process development, DFM, design of experiments, and process qualifications.
• Ensure development team maintains compliance with internal QMS and EHS procedures and guidelines.
• Lead cross functional teams supporting, DFMEA, PFMEA, Control Planning, and CAPA.
• Build upon the existing culture of innovation, accountability, and commitment by setting clear goals, providing performance reviews, and setting an example of continuous improvement. This includes interviewing, onboarding, coaching, and developing engineering talent.

Qualifications / Skills Required:

• BS in Mechanical Engineering, Biomedical Engineering, or related discipline (MS preferred)
• 5 years of catheter engineering experience
• 2 years leading new projects a proven track record of on-time, in-scope, in-budget delivery.
• 2 years of leadership or team management experience (leadership of technical or engineering teams preferred)
• Experience with DFM, FMEA, RCA, statistical method, and tolerance stack-ups/GD&T
• Working knowledge of 21 CFR 820, ISO 13485, and ISO 14971.
• Experience with CAD (SolidWorks preferred), common project management tools, and MS Office Suite.
• Excellent written and verbal communication skills.

Preferred Qualifications

• Exposure to Six Sigma and Lean methods.
• Contract manufacturing experience.
• Exposure to thermoplastics extrusion.

Cordica Medical is proud to be an Equal Employment Opportunity and Affirmative Action employer. We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics.

Pay: $115,000.00 - $150,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Employee assistance program
• Employee discount
• Flexible spending account
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Referral program
• Vision insurance

People with a criminal record are encouraged to apply

Work Location: In person

Salary : $115,000 - $150,000