The Staff Manufacturing Engineer provides manufacturing engineering leadership supporting the development, commercialization, and production of medical devices.
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).
- Highly 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.
Benefits
- Generous Paid Time Off
- 401k Matching
- Retirement Plan
- Health Insurance
- Dental Insurance
- Vision Insurance
- Life Insurance
- Short-Term Disability Insurance
- Long-Term Disability Insurance
- Adoption Assistance
- Employee Stock Purchase Plan
- Education Assistance
- Flexible Spending Account
- Health Savings Account
