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Manufacturing Engineer

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Job Title: Manufacturing Engineer

Job Status: Full Time Exempt

Reports to: Director, R&D

Location: On-site 60% —California, SF Bay Area. (Candidate may live in Bay Area or Dallas)

Amount of Travel Required: up to 20%

Work Schedule: Full-time

Positions Supervised: None

 

Position Summary:

The Manufacturing Engineer leads volume scale-up and commercialization build activities for the company’s Class II device(s). This individual is responsible for the development and validation of manufacturing processes, and works closely with production, R&D, RA/QA to drive product initiatives. The Manufacturing Engineer is a critical team member, reporting directly to the Director of R&D.

 

Essential Functions:

  • Essential Functions of the Position Include but are not limited to the following. Other duties may be assigned.

  • Primary manager of Contract Manufacturing Activities (e.g., production/quality/yield issues)

  • Lead product builds from clinical stage through launch and commercialization

  • Oversee supply chain management and equipment (e.g., calibration tools)

  • Manage COGS reduction, reliability improvements, continued DFM, etc.

  • Execute process improvements, validations, and ongoing test development

  • Creating, maintaining, and improving controlled technical documents (incl. BOMS, MPIs, inspection procedures) through change order processes

  • Design tools and tooling to optimize the manufacturing lines

  • Support Research & Development team with manufacturing strategy for future product development

  • Support Regulatory Affairs with manufacturing process flow and materials documents

  • Develop and document FDA and ISO compliant design history files, including risk management.

  • Ensure company compliance with Good Manufacturing Practices.

  • Support Quality in preparation of Design History Files, Complaint Handling and other areas of regulatory compliance.

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POSITION QUALIFICATIONS

Experience and Education:

  • Minimum B.S. degree in mechanical, electrical or biomedical engineering

  • Minimum 5+ years of life science manufacturing experience

  • Experience with injection molding

  • Experience with PCBA manufacturing

  • Hands-on technical troubleshooting skills for manufacturing issues

  • Demonstrated root cause analysis skills

  • Experience in supplier development and management

  • Experience establishing and driving operations key initiatives and NPI/design transfer of a product to Contract Manufacturing

  • Preferred experience with sterile disposable devices

  • Demonstrated understanding of FDA QS regulations and ISO 13485

  • Working knowledge of FDA requirements for Good Laboratory Practices

  • Effective working independently with minimal direction and within project teams

  • Excellent organizational and communication skills

  • Hands-on, driven work ethic and entrepreneurial spirit

  • Willing and able to travel as needed (typically 15-20%, 40-60% if not located in California)

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Computer Software / Programs:

  • Proficient in CAD (e.g., Solidworks)

  • MS Office, MS Project and general business software applications

  • Familiarity with statistical analysis systems (e.g., MATLAB, SAS) preferred

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