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

Computer Software / Programs :