Sr Manager Design and Construction
Core
Lead design and construction efforts for genetic analysis systems, ensuring validation and quality compliance for medical device manufacturing.
Role type
Senior Manager, Design and Construction (Medical Device/IVD)
Builds
Commercial and internal genetic analysis systems, validation programs, and manufacturing processes
Domain
Medical Device / In Vitro Diagnostics (IVD) / Genomics
Required skills
FDA regulations (21 CFR Part 11/820), ISO 9001/13485/IEC 62304/MDSAP compliance, Validation Principles, FMEA, Risk Analysis, CAPA, Manufacturing process knowledge, Team management (6-10 FTE), Strategic planning, Cross-functional leadership
Preferred skills
Six Sigma Black Belt, PMP, ASQ accreditations, Statistical Process Control, DOE techniques, RUO to Dx/IVD transition experience
Technologies
FDA 21 CFR Part 11, ISO 9001, ISO 13485, IEC 62304, MDSAP
Responsibilities
Drive staff results through coaching and performance management; Establish strategic goals based on business and operations data; Maintain staff via recruiting, training, and safety compliance; Ensure validation programs meet regulatory requirements; Report on validation activities and audit readiness; Estimate timelines and budgets for validation engineering; Formalize and document processes; Assist in designing and improving verification tests; Participate in new product development teams; Lead cross-functional teams to address system issues
Seniority
Senior Manager, hands-on leadership