Senior Process Engineering Manager

Responsibilities

• Lead and mentor a team of process development engineers, manufacturing engineers and equipment technicians in support of current manufacturing as well as new product development to achieve Operations goals
• Design and develop manufacturing processes, tooling and fixtures that enhance safety, Quality and productivity. Own line layout and space utilization in all clean rooms
• Manage equipment qualification and process validation activities (IQ/OQ/PQ) including protocol development, execution, data analysis and reporting to deliver process capability against all specifications prior to launch
• Manage product scale-up and design transfer activities from R&D to Manufacturing to ensure completion per project plans and that design intent is maintained
• Collaborate with the engineering team to develop, manage and update work instructions, process documents, risk documents and workmanship standards and ensure that operators and technicians are properly trained
• Collaborate with R&D, Quality and Manufacturing to address process performance issues and support prototype builds, pilot production of new products, product changes and enhancements
• Drive continuous improvement initiatives for commercial products to enhance yield, quality, productivity, workflow, reliability, efficiency and cost savings using tools such as Measurement System Analysis (GR&R), Process Capability Analysis (Cpk) and Statistical Process Control (SPC)
• Provide subject matter expertise in the following areas: plastics extrusion, injection molding, packaging, adhesives, coatings, laser fibers and statistics
• Monitor and report Manufacturing and Quality metrics; support investigations and corrective actions for non-conforming products, CAPA’s and customer complaints
• Lead root cause analysis and corrective actions for production issues, product defects, customer complaints and other technical challenges
• Assist with regulatory approvals and responses related to existing products
• Supervise and actively develop staff and provide training on relevant processes and technologies
• Develop departmental budgets and ensure adequate resourcing to support planned activities
• Support identification and approval of suppliers for manufacturing processes and equipment. Identify alternative suppliers as needed. Support resolution of Supply Chain and component obsolescence issues, including supplier/customer coordination
• Proactively communicate project progress, risk, s and recommendations to management
• Perform additional tasks as needed to support team and organizational success

• Minimum of 10 years of process or manufacturing engineering experience in an FDA/ISO-regulated medical device industry with a minimum of 4 years of supervisory experience.
• Experience with ISO 13485 and FDA Quality System Regulation.
• Process Development experience in medical devices, especially with plastics processes such as extrusion, injection molding, and adhesive bonding.
• Demonstrated project management skills with the ability to prioritize multiple concurrent projects in a fast-paced environment and identify/resolve issues as they arise with minimal supervision.
• Lean Six Sigma training or certification and knowledge of statistical data analysis techniques (DOE, GR&R, Cpk, SPC); experience with Minitab or other statistical evaluation software.
• Basic CAD experience (preferably Solid Works).
• Cross-functional team player with a strong work ethic, strong engineering and problem-solving skills, creative thinking, good decision-making skills, high attention to detail, effective interpersonal skills, and excellent verbal/written communication and presentation skills.
• Experience with biomedical fiber optic components and processing, clean room monitoring and management, or process automation design and implementation is a plus.
• Bachelor’s degree in mechanical, plastics, biomedical, or related engineering field, or equivalent combination of relevant education and demonstrated years of experience in a related role.