Director of Manufacturing Engineering

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
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)

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