Staff Manufacturing Engineer

About the role

The Staff Manufacturing Engineer provides manufacturing engineering leadership supporting the development, commercialization, and production of medical devices. 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.

Responsibilities

• Operate as a primary manufacturing technical resource for product development and lead manufacturing initiatives focused on cost reduction, lead time improvement, yield enhancement, and process robustness at contract manufacturers.
• Define and drive manufacturing strategies across the product portfolio to improve cost, scalability, and operational performance.
• Support the identification, technical evaluation, and relationship management of external manufacturing partners for complex medical devices.
• 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.
• Establish technical standards within the engineering organization and mentor junior engineers.
• 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.
• Develop and maintain work instructions and documentation for manufacturing processes.

Requirements

• 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.
• Strong knowledge of quality systems, inspection standards, equipment, and best practices.
• 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).
• Proficient with CAD software (e.g., SolidWorks).
• Strong analytical thinking and problem-solving skills, with the ability to communicate technical concepts clearly to both technical and non-technical audiences.
• Demonstrated success working cross-functionally with R&D, Quality, Regulatory, Marketing, and Operations teams.
• Strong knowledge of engineering materials and their applications, particularly metals and plastics used in medical device manufacturing, with preferred knowledge of composite materials.
• Demonstrated ability to manage multiple projects and priorities in a fast-paced environment.
• Strong knowledge of FDA regulations and quality standards (21 CFR Part 820, GMP, ISO 13485, ISO 9001, ISO 14971).
• Hightly proficient with statistical methods and quality tools such as SPC, Gage R&R, and Design of Experiments (DOE).
• Demonstrated experience working with contract manufacturers and suppliers to develop, validate, and improve manufacturing processes.
• Expert knowledge in the interpretation and application of Geometric Dimensioning and Tolerancing (GD&T).
• Strong verbal, written, and organizational communication skills with the ability to operate effectively in a dynamic environment.
• Required to travel domestically up to 20% annually. Potential for international travel.

Qualifications

• Bachelor's degree in Engineering (Mechanical/Manufacturing, or related field)
• 10+ years of experience in manufacturing or development engineering, preferably within the medical device industry.
• Licenses and Certifications: Lean / Six Sigma Black Belt or Master Black Belt certification preferred (or in progress).

Benefits

At this time, ATEC Spine does not sponsor employment visas for this position. Candidates must be authorized to work in the United States without the need for current or future employer sponsorship.

Pay

$150,000 to $170,000 Annual Salary

Schedule

Full-Time Annual Salary