Sr. Manufacturing Engineer I
About The Position
SetPoint Medical’s Sr. Manufacturing Engineer will be responsible for leading and improving manufacturing processes across the product lifecycle, including development, technology transfer, and commercial production. In addition, the Sr. Manufacturing Engineer will identify and on-board 2nd source suppliers of our components and products as well as integrating next-generation platforms from the Product Development Department into manufacturing. This role works cross-functionally with Product Development, Operations, Quality, and external partners to ensure robust, scalable, and compliant manufacturing solutions. The Sr. Manufacturing Engineer plays a key part in the development and implementation of continuous improvement efforts within the organization.
Requirements
- B.S. Degree in Mechanical, Electrical, Biomedical Engineering, or related field (advanced degree preferred)
- 7+ years of relevant experience, depending on level
- Experience in medical device manufacturing (Class II/III preferred)
- Strong knowledge of process validation, manufacturing systems, and regulatory requirements
- Experience with failure investigation tools and methodologies
- Familiarity with ISO 13485, GMP, and FDA regulations
- Experience working with contract manufacturers and cross-functional teams
- Strong technical problem-solving and analytical skills
- Ability to lead projects and influence cross-functional teams
- Strong communication skills (technical and non-technical)
- Ability to manage multiple priorities in a fast-paced environment
- Proficiency with manufacturing tools, equipment, and documentation systems
Nice To Haves
- Experience with CAD and/or data analysis tools preferred
Responsibilities
- Lead development, implementation, and optimization of manufacturing processes for medical device products
- Plan, execute, and document process validation activities (IQ/OQ/PQ) and equipment qualifications
- Support technology transfer from product development to manufacturing, including process scale-up and readiness
- Support all manufacturing qualification activities required for a FDA submission and approval of next generation products
- Identify and complete all deliverables needed for second sourcing our device components or the entire device itself (vendor NDA, scope of work, drawing reviews, characterization studies, validation/verification activities, first article complete, FDA approval) with minimal supervision
- Conduct root cause investigations and implement corrective and preventive actions (CAPA)
- Collaborate cross-functionally with Product Development, Quality, Operations, and external manufacturers
- Develop and maintain manufacturing documentation including work instructions, procedures, and specifications
- Identify and implement process improvements to enhance quality, efficiency, and cost-effectiveness
- Support QMS compliance through participation in NCR, CAPA, audits, and design control activities
- Provide technical leadership and mentorship to junior engineers and technicians
- Contribute to planning, prioritization, and execution of engineering projects and initiatives
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What This Job Offers
Job Type
Full-time
Career Level
Senior
