Director, Capital Equipment Manufacturing Engineering
Location
San Jose, CA
Level
Manager / Director
Department
MedTech
Type
Salary
$213,000 - $251,000
Job Description
Posted on:
2025-06-02
Responsibilities
- Lead the new product introduction manufacturing engineering team for capital equipment.
- Manage equipment and process qualification, validation, and manufacturing documentation.
- Build relationships with R&D, Quality, Supply Chain, and Regulatory functions.
- Define and implement cost improvements and ensure continuity of production.
- Hire, lead, and mentor the capital equipment operations team.
- Create and operate within a defined budget to maximize product margin.
- Ensure compliance with FDA and international standards.
Job Requirements
- Bachelor’s degree in engineering discipline.
- Minimum 7 years of experience in the Medical Device industry.
- Minimum 5 years of experience in Operations and managing engineering disciplines.
- Strong knowledge of cGMPs and applicable FDA and ISO standards.
- Excellent communication and project management skills.
- Demonstrated leadership skills and ability to resolve conflicts.
- Competency with Microsoft Office and ability to learn other software as needed.
