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Description
SetPoint Medicals 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
Scope and ownership of responsibilities will vary by level.
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
Leveling & Career Progression
Level-specific expectations are defined in the Engineering Tiers and Career Progression Framework.
In general:
Sr. Manufacturing Engineer I: Fully competent engineer; independently executes work and leads components of projects
Sr. Manufacturing Engineer II: Advanced technical contributor; leads major workstreams, drives cross-functional initiatives, and influences technical direction
Minimum Qualifications
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
Skills & Abilities
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
Experience with CAD and/or data analysis tools preferred
Physical Requirements
Ability to sit at a desk and work on a computer for extended periods
Ability to lift up to 15 pounds occasionally
Work Location and Travel
Company Headquarters in Valencia, CA
Minimal travel opportunities may be available based on interest and business need
Company Description
SetPoint Medical is a commercial-stage medical technology company dedicated to improving care for people living with chronic autoimmune diseases.
Department: Operations
Reports To: Sr. Manager, Manufacturing Engineering
FLSA Status: Exempt
Location: Valencia, CA
In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification form upon hire. Candidates must have and maintain authorization to work within the United States as a condition of employment.
We are proud to be an equal opportunity employer and we value diversity. SetPoint does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.
Salary Description
$110K - $150K yr - Depending on experience