Sr Process Engineer

Integra Lifesciences Holdings Corporation

Full-time

Management of Companies and Enterprises

About the position

The position involves supporting product development and manufacturing operations within a medical device manufacturing environment. The role focuses on assessing the feasibility of new manufacturing processes, developing specifications for new equipment, and implementing these processes to enhance patient outcomes and innovate treatment pathways.

Responsibilities

• Work as part of a cross-functional team to transfer implantable collagen-based products from R&D to full-scale manufacturing.
• Lead efforts to create novel processes for full-scale manufacturing of Integra Regenerative products.
• Perform hands-on laboratory work for prototyping, testing, and optimizing processes from R&D to manufacturing.
• Develop specifications for new manufacturing processes and equipment.
• Work independently with vendors to develop new equipment and establish raw material specifications.
• Apply experience with manufacturing process equipment to lead the selection and design of equipment.
• Provide daily analytical and technical support to meet manufacturing objectives.
• Implement problem-solving skills to identify potential issues and develop mitigation plans.
• Train manufacturing personnel on new processes and changes to current operations.
• Lead teams in performing and updating Process FMECA risk management.
• Assemble and lead technical teams for projects involving various departments.
• Generate technical and compliance documents in accordance with company procedures and regulatory requirements.
• Develop and maintain effective cross-functional working relationships.

Requirements

• BS/MS in Mechanical Engineering, Bioengineering, Pharmaceutical Engineering, Chemical Engineering, Materials Science, or equivalent.
• 5+ years of experience in a medical device or pharmaceutical environment.
• Experience with Quality System Regulation (QSR), GMP, Design Control, and Process Validation guidelines.
• Knowledge of validation fundamentals (IQ/OQ/PQ), statistics, and process capability (CpK).
• Experience in clean rooms, lyophilization, or biomaterials is desirable.
• Exceptional problem-solving skills and practical product fabrication experience.

Nice-to-haves

• Use of statistical process tools such as Minitab, Six Sigma, and Lean.