Medical Device Senior Advanced Manfacturing Engineer

The Medical Device Senior Advanced Manufacturing Engineer will have high collaboration between R&D, Pilot, and commercial manufacturing, and contribute to from Early Human Use to the commercialization of new products. The Medical Device Senior Advanced Manufacturing Engineer will also ensure that design and manufacturing processes are characterized, robust, scalable utilizing best technologies, reflect standard work, are capable and compliant with Regulatory requirements, and are validated for Design Control, Manufacturing using LEAN Six Sigma, Design for Manufacturing and Design for Cost Methodologies. The Medical Device Senior Advanced Manufacturing Engineer will act as a liaison between R&D, Supplier Development, Quality, and Operations team members assigned to the project. This position is full time and offers a hybrid work schedule requiring you to be in the office three days per week and an option to work from home two days per week. Note that work schedules and office reporting requirements may change from time to time based on business needs.

• Developing manufacturing processes to support medical device product development projects, especially the project with catheters and other disposable devices
• Collecting information to prospectively evaluate quality, cost, delivery, and management of contract manufacturing partners
• Supervising and collaborating with contract manufacturers in the selection and development of manufacturing processes and sites
• Ensure DFM, Six Sigma, and LEAN considerations are incorporated into product and process designs, including design and process 3P
• Review engineering product specifications, CAD data/drawings, as part of the design review process to ensure they meet industry and manufacturing standards and practices
• Manage pilot production builds, planning, tracking, and execution
• Drive the development and execution of complex experiments and tests (including writing and executing protocols) on new or existing product lines to qualify and validate manufacturing processes, analyze results, make recommendations, and develop reports
• Responsible for Characterization and Validation activities, including CTQ flow-down and identification of critical control points within manufacturing
• Act as the liaison between Contract Manufacturing Organization (CMO), and company to co-ordinate manufacturing activities as directed by Management
• Deploy manufacturing risk assessment and mitigations, including hands-on and resourceful action plans
• Responsible for part/drawing release, and accuracy of the Bill of Materials (BOM)
• Developing and maintaining manufacturing work instructions, equipment instructions, and other documents that require quality management system controls
• Coordinating technical communications between company and contract manufacturers, including design transfer
• Developing processes to monitor manufacturing performance on an ongoing basis to ensure quality, productivity, and delivery
• Providing technical expertise in conducting PFMEA and developing process validations
• Coordinating builds for prototypes, validations, and pilot runs
• Sharing expertise in Lean Six Sigma process excellence principles
• Collaborating with cross-functional product development teams including project managers, optical engineers, mechanical engineering, electrical engineers, software engineers, quality engineers, regulatory specialists, clinical specialists, marketers, buyers, and others
• Ability to travel up to 20% domestically as needed

• Development and maintenance of project task list for DFM Activities
• Creation and maintenance up-to-date BOM’s, Work Instructions, and Travelers
• Creation and maintenance pFMEA

• Education: Bachelor’s degree or higher in an engineering discipline required
• At least five (5) years of experience in medical device manufacturing engineering
• At least three (3) years of experience in new product development manufacturing engineering, including time working with contract manufacturers/vendors working with electronics testing, and/or catheter manufacturing is strongly preferred
• Proven track record in design transfers to Operations and process, equipment validation experience
• Understand injection molding, polymers, and commonly used materials in the medical device space, such as Nitinol, with working knowledge of metal processing
• Technical expertise in manufacturing engineering: design for manufacturability, design and process excellence methodologies including Six Sigma, LEAN experiencGMPcGMP, EH&S guidelines, supplier development engineering, and process validation
• Proficient in the use of CAD, preferably SolidWorks
• Strong proficiency with Microsoft Office Suite, and Minitab Statistical Analysis software (or equivalent)
• Lean and/or Six Sigma certifications preferred