Sr. Staff Engineer - Process & Equipment Design
Core
Leading the development, deployment, and industrialization of manufacturing equipment and process technologies for the Specimen Management Business Unit, bridging Product Development and Manufacturing.
Role type
Sr. Staff Engineer - Process & Equipment Design
Builds
Scalable, compliant, and operator-focused manufacturing solutions for medical device products.
Domain
Medical Technology / Regulated Manufacturing
Required skills
Capital project management, User Requirements Specifications (URS) definition, supplier/vendor management, risk analysis (FMEA), validation planning, stage-gate governance, Design for Manufacturability (DFM), regulatory compliance (GMP, ISO, FDA), continuous improvement methodologies (Lean, SPC), financial acumen.
Preferred skills
Team leadership, MBA or MS in Engineering, Mechanical/Electrical engineering background.
Technologies
None explicitly listed
Responsibilities
Develop and execute equipment and process technology roadmaps; Lead capital equipment projects from concept through production launch; Partner with Product Design to incorporate DFM principles; Oversee equipment integration, commissioning, and process optimization; Drive standardization of equipment and processes across sites; Manage project portfolios and supplier performance.
Seniority
Sr. Staff, hands-on IC with strategic planning and cross-functional leadership