Director, Capital Equipment Manufacturing Engineering
Location
San Jose, CA
Level
Manager / Director
Department
MedTech
Type
Salary
$213,000 - $251,000
Job Description
Posted on:
2025-07-16
Responsibilities
- Lead the new product introduction manufacturing engineering team for capital equipment.
- Manage equipment and process qualification and validation, including pFMEA and manufacturing documentation.
- Build relationships with R&D, Quality, Supply Chain, and Regulatory functions.
- Implement continuous improvement structures to maximize yield and optimize reliability.
- Hire, lead, and mentor the capital equipment operations team.
- Create and manage budgets to maximize product margins.
- Ensure compliance with FDA and international standards.
Job Requirements
- Bachelor’s degree in an engineering discipline.
- Minimum of 7 years experience in the Medical Device industry.
- Minimum of 5 years experience in Operations and managing engineering disciplines.
- Strong knowledge of cGMPs and FDA/ISO standards.
- Excellent communication and project management skills.
- Demonstrated leadership abilities in cross-functional collaboration.
- People management skills including interviewing, hiring, and performance management.
