Posted 9 hours ago
Staff Manufacturing Engineer
Alphatec SpineStaff Manufacturing Engineer
Requirements
Bachelor's degree in Engineering, 10+ years manufacturing engineering experience, Medical device industry experience, SolidWorks proficiency, GD&T expertise, FDA/ISO regulatory knowledge, Statistical methods (SPC, DOE)
Skills
SolidWorksGD&TSix Sigma
About the role
Responsibilities
- Provide manufacturing engineering leadership for medical device development and production
- Oversee product portfolios manufactured by contract manufacturers to improve cost, lead time, and yield
- Lead technical design reviews and specification transfers using DFM, DFI, and DFA principles
- Serve as technical authority for New Product Introduction (NPI) and design transfer
- Lead manufacturing process development and validation activities (IQ/OQ/PQ)
- Manage external manufacturing partner relationships and technical evaluations
- Lead FMEA, nonconformance investigations, and CAPA implementation
- Mentor junior engineers and establish technical standards
Requirements
- Bachelor's degree in Mechanical, Manufacturing, or related Engineering field
- 10+ years of experience in manufacturing or development engineering, preferably in medical devices
- Strong knowledge of machining, injection molding, fabrication, and assembly processes
- Proficiency with CAD software such as SolidWorks
- Expert knowledge of Geometric Dimensioning and Tolerancing (GD&T)
- Deep understanding of FDA regulations (21 CFR Part 820) and ISO standards (13485, 14971)
- Proficiency with statistical methods including SPC, Gage R&R, and DOE
- Ability to travel domestically up to 20% annually
Preferred Qualifications
- Lean / Six Sigma Black Belt or Master Black Belt certification
- Knowledge of composite materials
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Alphatec Spine · Carlsbad
