Senior Process Engineer I
Integra LifeSciences
Summary
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.
Job description
Key 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.
Qualifications
- 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.
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
- 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
Benefits
- Medical, Dental & Vision
- Life Insurance
- Short- & Long-Term Disability
- Business Accident Insurance
- Group Legal Insurance
- 401(k) Savings Plan
Company overview
Integra LifeSciences Holdings Corporation is a global medical technology company headquartered in Princeton, New Jersey, founded in 1989. As a publicly traded company on NASDAQ under the symbol IART, Integra specializes in developing and manufacturing innovative medical devices for neurosurgery, reconstructive surgery, and general surgery applications. The company is renowned for its pioneering work in regenerative medicine, most notably the Integra artificial skin, which was the first commercially reproducible skin tissue used to treat severe burns and other skin wounds. Integra's comprehensive product portfolio includes surgical instruments, neurosurgical devices, advanced wound care solutions, orthopedic hardware, dermal regeneration products, and tissue-engineered wound dressings. With approximately 3,946-4,396 employees worldwide, the company serves hospitals, outpatient surgery centers, and medical practices globally through direct sales representatives and an extensive distribution network. Integra's commitment to limiting uncertainty for surgeons enables healthcare professionals to focus on providing optimal patient care through simplified procedures and reliable medical technology solutions.