Senior Process Engineering Manager

Gentuity•Sudbury, MA

11d

About The Position

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 cleanrooms. 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, risks and recommendations to management. Perform additional tasks as needed to support team and organizational success.

Requirements

Minimum of 10 years of process or manufacturing engineering experience in a medical device production industry with a minimum of 4 years of supervisory experience.
Experience with ISO 13485 and FDA Quality System Regulations.
Process Development experience in medical devices, especially with plastics processes such as extrusion, injection molding and adhesive bonding.
Demonstrated project management skills with 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.
Risk management experience (DFMEA, PFMEA.
Basic CAD experience (preferably SolidWorks).
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.
Bachelor’s degree in mechanical, plastics, biomedical (or related Engineering degree) plus minimum of 7 years of experience working in an FDA/ISO regulated medical device/medical equipment industry or equivalent education and years of experience.

Nice To Haves

Experience with biomedical fiber optic components and processing is a plus.
Experience with clean room monitoring and management protocols is a plus.
Experience with automation design and implementation is a plus.

Responsibilities

Lead and mentor a team of process development engineers, manufacturing engineers and equipment technicians
Design and develop manufacturing processes, tooling and fixtures that enhance safety, Quality and productivity
Own line layout and space utilization in all cleanrooms
Manage equipment qualification and process validation activities (IQ/OQ/PQ)
Manage product scale-up and design transfer activities from R&D to Manufacturing
Collaborate with the engineering team to develop, manage and update work instructions, process documents, risk documents and workmanship standards
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
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
Proactively communicate project progress, risks and recommendations to management
Perform additional tasks as needed to support team and organizational success