Alphatec Spine
Staff Manufacturing Engineer
Carlsbad, California, United States · Staff+ · Full-time
No sponsorship$150k-$170kDetected 141 days ago
Supply ChainProcess ImprovementSolidWorksGD&TGMPFDA RegulatoryMedical DevicesLeadershipCommunicationProblem Solving
About the role
- The Staff Manufacturing Engineer provides manufacturing engineering leadership supporting the development, commercialization, and production of medical devices.
- Establish technical standards within the engineering organization and mentor junior engineers.
- Strong knowledge of manufacturing processes (e.g., machining, injection molding, fabrication, secondary/finishing operations, and assembly) and their application in the production of medical devices.
Responsibilities
- This role oversees a portfolio of products manufactured primarily by contract manufacturers and drives improvements in cost, lead time, manufacturability, and overall operational performance.
- The position collaborates cross-functionally with Product Development, Sustaining Engineering, Quality, Supply Chain, and external manufacturing partners to ensure robust manufacturing processes and scalable production.
- Define and drive manufacturing strategies across the product portfolio to improve cost, scalability, and operational performance.
- Lead technical design reviews and specification transfer from R&D to internal and external suppliers, ensuring cost-effective manufacturability and inspection through DFM, DFI, and DFA principles.
- Serve as the technical authority for design transfer and new product introduction (NPI), ensuring successful transition from development to production.
- Lead manufacturing process development and validation activities (IQ/OQ/PQ) for new and existing products.
- Partner with internal teams and external suppliers to resolve manufacturing issues and drive improvements in process capability, yield, and throughput.
- Lead and participate in Failure Mode and Effects Analysis (FMEA) to mitigate risks to product quality and patient safety.
- Lead investigations into nonconformances and implement corrective and preventive actions (CAPA).
- Analyze manufacturing data to identify trends and drive continuous improvement initiatives.
Requirements
- The requirements listed below are representative of the knowledge, skill, and/or ability required.
- Strong experience with the creation, review, and analysis of engineering design specifications and the application of Design for Manufacturability (DFM), Design for Inspection (DFI), and Design for Assembly (DFA).
Compensation
- Alphatec Spine, Inc. complies with state and federal wage and hour laws and compensation depends upon candidate's qualifications, education, skill set, years of experience, and internal equity. $150,000 to $170,000 Full-Time Annual Salary
Benefits
- Support the identification, technical evaluation, and relationship management of external manufacturing partners for complex medical devices.
- Strong knowledge of engineering materials and their applications, particularly metals and plastics used in medical device manufacturing, with preferred knowledge of composite materials.
Visa & Work Authorization
- At this time, ATEC Spine does not sponsor employment visas for this position
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This listing is sourced directly from Alphatec Spine's careers page and normalized into a canonical job model.