HumCap, Inc.
Job Description
HumCap's client, a company in the biomedical technology space, is searching for a Director of Manufacturing Engineering who will build and lead the manufacturing engineering team. Reporting to the COO, the Director of Manufacturing Engineering 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. This is an opportunity for an experienced operations executive to get involved early and play a central role in shaping all operations activities at the company.
Responsibilities
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.
Qualifications
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)
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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HumCap's client, a company in the biomedical technology space, is searching for a Director of Manufacturing Engineering who will build and lead the manufacturing engineering team. Reporting to the COO, the Director of Manufacturing Engineering 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. This is an opportunity for an experienced operations executive to get involved early and play a central role in shaping all operations activities at the company.
Responsibilities
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.
Qualifications
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)
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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