Senior Process Engineer I

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.

Job Description

The Senior Process Engineer independently leads cross-functional engineering projects from planning through implementation, driving accountability, alignment, and results across teams. The role is responsible for understanding, optimizing, and sustaining manufacturing processes within a value stream, leveraging Lean and Six Sigma methodologies to improve processing, layout, workflow, assets, assembly methods, workforce utilization, and process efficiency. This position also provides end-to-end process and product understanding and control, including managing lifecycle and sustaining engineering changes.

Salary Pay Range

$71,000.00 - $98,000.00 USD Salary

Our salary ranges are determined by role, level, and location. Individual pay is determined by several factors including job-related skills, experience, and relevant education or training . In addition to base pay, employees may be eligible for bonus, commission, equity or other variable compensation . Your recruiter can share more about the specific salary range for your preferred location during the hiring process.

Responsibilities

Independently lead cross-functional process and product projects across Product Development, Quality Assurance, Facilities, Regulatory, and Manufacturing, ensuring effective planning, coordination, execution, and delivery of project objectives.; Develop cross-functional partnerships with EHS, Product Development, Process Technology, Centers of Excellence, Facilities, Quality, Regulatory, Planning, and Procurement to address process challenges and lifecycle/sustaining changes.; Represent value stream teams on strategic site and enterprise projects involving quality improvements, lifecycle management, and new product introductions.; Initiate, develop, and implement engineering studies, IQ/OQ/PQ/TMV validations, manufacturing process requirements and specifications, ECR/ECOs, and engineering drawings.; Leverage statistical process control and analyze process inputs, outputs, and parameters to improve manufacturing yield, reduce scrap, and error-proof manufacturing processes.; Perform technical investigations related to non-conformances, FMEA, and CAPA.; Identify, financially justify, and lead projects focused on process, quality, reliability, and cost improvements using Lean Six Sigma tools and methodologies.; Ensure BOMs, routers, and work instructions align with manufacturing processes and support cost accuracy throughout the product lifecycle.; Drive process improvements to achieve targeted KPIs.; Develop hands-on product, process, and equipment training programs.

Requirements

Bachelor’s degree in Engineering or equivalent with 5+ years of experience, or Master’s degree with 3+ years of experience.; Demonstrated ability to independently organize, manage, and deliver complex cross-functional projects, influencing stakeholders and driving accountability without direct authority.; Experience with CNC machining processes, including milling, turning, tooling, fixturing, and manufacturing process optimization.; Experience with statistical process control tools such as SPC and Minitab.; Lean Six Sigma experience.; Strong organizational and communication skills.; Project management and process improvement experience, PMP preferred.; Knowledge of ERP/MRP systems and Microsoft Office.; Experience with systems/tools such as SAP, statistical analysis tools, MS Project, Jira, and QMS platforms.; Experience working within a regulated manufacturing environment, including GMP, FDA, ISO 9001, ISO 13485, EU MDR, and other applicable requirements.