Sr. Project Engineer II

Changing lives. Building Careers. Joining us is a chance to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, our colleagues are challenging what’s possible and making headway to innovate new treatment pathways to advance patient outcomes and set new standards of care. The Senior Project Engineer II
- Utilities & Equipment leads cross‑functional engineering initiatives to design, develop, validate, and commercialize medical devices in compliance with regulatory and quality requirements. This role is responsible for end‑to‑end project execution—from concept feasibility through product launch—ensuring that technical objectives, timelines, and quality standards are met. The Senior Project Engineer acts as a technical leader, problem‑solver, and liaison between engineering, manufacturing, quality, regulatory, suppliers, and external partners.

They plan and execute their duties in compliance with corporate policies, U.S. Food and Drug Administration regulations, Good Manufacturing Practices (GMP), ISO 9001, ISO 13485, EU MDR, the Canadian Medical Device Regulations (CMDR), and other applicable regulatory agencies.

Under direct supervision of the Engineering Manager

• Develop cross-functional network with Environmental, Health, and Safety (EHS), site value stream teams, product development, process technology, Centers of Excellence (CoE's), facilities, quality, regulatory, planning, procurement to execute projects to support facilities, equipment, and process changes.
• Assist in strategic site and enterprise projects on cross-functional teams addressing quality improvements, lifecycle management efforts, new product introductions, etc.
• Initiate, develop and implement engineering studies, IQ/OQ/PQ/TMV validations, manufacturing process requirements, specifications, Engineering Change Requests/Orders (ECR/ECO), and Engineering Drawings for equipment, processes and facilities.
• Leverage statistical process control (as necessary), analyze and trend existing process parameters, process inputs and outputs, improve manufacturing yields, reduce manufacturing scrap, and error proof manufacturing processes.
• Perform timely technical investigations, non-conformance, Failure Mode Effects Analysis (FMEA), and Corrective and Preventive Action (CAPA).
• Identify, financially justify, and lead projects to drive process, quality, reliability and cost improvements leveraging advanced technologies, lean six-sigma tools and methodologies.
• Leverage project management tools/techniques/methods manage projects in their entirety including scheduling, resource forecasting, and financial budgeting.
• Partner with product development to develop prototypes, specifications, manufacturing processes, and equipment to transfer new and/or improved products to manufacturing.
• Track and financial project budgets including labor, expense, capital, scrap, inventory, and risk.
• Develop hands‑on product/process/equipment training programs.
• Lead cross-functional process and product project teams including suppliers, product development, quality assurance, facilities, regulatory, and manufacturing.
• Complete other job‑related duties as assigned.

• A Bachelor’s degree in engineering or equivalent with 8+ years of experience or Master’s degree with 3+ years of experience.
• Experience with statistical process control tools required (SPC, Minitab, other software) required.
• Lean Six Sigma experience required.
• Demonstrate excellent organizational and English communication skills (oral & written).
• Project management and process improvement experience, PMP desired.
• Knowled…