Overview In this role you lead a mid-sized team to ensure compliant validation and manufacturing readiness for genomic analysis systems. You align quality and engineering activities with product development goals, driving continuous improvement and cross-functional collaboration. You shape validation programs to meet FDA and international standards and guide teams through complex regulatory environments. This position offers impact across development, manufacturing and market delivery in a mission-driven genomics company.
Compensation / Benefits- access to genomics sequencing
- health/dental/vision benefits
- retirement benefits
- paid time off
- bonus or equity potential
- inclusive, growth-oriented culture
Responsibilities- Manage staff performance, coaching, recruiting, and development to sustain productivity and a safe work environment
- Set strategic goals by collecting business/operational data, defining objectives, and evaluating outcomes
- Oversee validation programs to meet FDA/ISO/IEC requirements and support multiple markets
- Coordinate documentation, processes and standardization across teams; drive timely validation engineering initiatives
- Lead cross-functional product development and manufacturing teams; participate in new product development cycles
- Collaborate with scientists, engineers, marketing, and project management to deliver genetic analysis systems
- Potentially lead cross-functional teams to resolve system issues
- Communicate validation/audit readiness and maintain manufacturing audit support
Key requirements- 5-7 years managing a mid-size team (6-10 FTE) with coaching and disciplinary experience
- Experience in medical device/IVD quality systems and process controls in FDA-regulated environments
- 5-7 years in manufacturing, QA or engineering within FDA-regulated settings
- Knowledge of FDA 21 CFR Part 11/820, ISO 9001/13485, IEC 62304, MDSAP
- Knowledge of validation principles and industry practice
- Proven continuous improvement leadership with ability to plan and execute timelines
- Experience with FMEA and risk analysis; CAPA
- Strong analytical and communication skills; ability to discuss technical topics with non-technical stakeholders
- Nice-to-have: RUO to Dx/IVD transition experience; SPC/DOE knowledge; Six Sigma Black Belt, PMP, ASQ certifications
- Solid understanding of medical device manufacturing processes
- Domain experience in cross-functional, project-based environments
- strong verbal and written communication
- leadership and people development
- analytical problem solving
- FDA/ISO/MDSAP regulatory knowledge
- Validation principles and quality systems
- FMEA and risk analysis
