GIE EDI Senior Staff Engineer for Specimen Management

About This Role

The Senior Staff Engineer for Equipment Development & Industrialization (EDI) leads the development and deployment of manufacturing equipment and process technologies for the Specimen Management Business Unit. This role translates new product development and design change requirements into robust equipment and operator-centric processes, ensuring efficient, compliant, and cost-effective production. This position manages a portfolio of projects, participates in capital planning, and ensures adherence to stage-gate governance.

Responsibilities

• Develop and execute the equipment and process technology roadmap for assigned sites/products aligned with segment priorities.
• Define URS and equipment specifications to meet manufacturing, safety, and regulatory requirements.
• Partner with PMO to ensure budget, timeline, and scope compliance for all EDI projects.
• Lead multiple capital projects from concept through FAT/SAT, installation, and validation.
• Manage vendor relationships, including selection, contracting, and performance oversight.
• Ensure risk management through FMEA, design reviews, and validation protocols.
• Work with Product Design to embed Design for Manufacturability (DFM) principles early in development.
• Align with Quality/Regulatory to ensure compliance with GMP, ISO, and FDA requirements.
• Collaborate with Operations & Maintenance to design equipment for reliability, maintainability, and operator safety.
• Oversee equipment integration and process optimization during ramp-up.

Requirements

• Bachelor's degree in Mechanical, Electrical, or related Engineering
• 10+ years in equipment/process development and leadership
• Proven ability to manage capital projects
• Experience with stage-gate governance, risk analysis (FMEA), and validation
• Strong financial acumen and project management skills

Qualifications

• B.S. in Engineering (Mechanical Engineering preferred), MBA or MS in Engineering is preferred.
• 10+ years in equipment/process development and leadership. Proven ability to manage capital projects, influence cross-functional teams, and deliver results in regulated environments.

Nice to Have

• MBA or MS in Engineering
• Familiarity with Lean, SPC, and continuous improvement methodologies

Skills

* Required skills

Benefits