Manufacturing Process Development Leader

3 weeks ago


New Brighton, Minnesota, United States Shockwave Medical Full time
Job Overview:
We are seeking an experienced Manufacturing Process Development Leader to join our team at Shockwave Medical. As a key member of our R&D group, you will play a crucial role in designing, developing, and implementing processes, tooling, and fixtures for our medical devices.

Key Responsibilities:
• Design and develop processes, tooling, and fixtures for medical devices, collaborating with R&D, Quality, and Production departments.
• Analyze process performance and capabilities for company products, identifying areas for improvement.
• Perform tolerance analyses for components, manufacturing materials, packaging, and supplies used for in-house processing, ensuring compliance with quality standards.
• Develop and maintain process Failure Modes and Effects Analyses (pFMEAs) for company processes, reducing the risk of defects and improving overall quality.
• Participate in development and maintenance of product design FMEAs, working closely with cross-functional teams to ensure seamless integration.
• Identify requirements, advise Operations management, prepare proposals, and implement equipment & fixturing needed for development and manufacturing efforts, driving business growth and efficiency.
• Develop and maintain documentation for design control, product configurations, and other Quality System requirements, ensuring regulatory compliance and maintaining high-quality standards.
• Lead and/or actively participate in product/process engineering problem resolution, leveraging your expertise to resolve complex issues and drive results.
• Lead and/or actively participate in process/product improvement projects, Validation activities (IQ, OQ, and PQ), and other initiatives that drive business growth and improve quality.
• Collaborate with Materials, QA, and R&D departments to select suppliers, develop technical specifications, and ensure compliance with quality standards.
• Conduct complex engineering studies and investigations, preparing reports for company leadership and driving informed decision-making.
• Provide engineering guidance to other departments, help to train new engineers, and stay up-to-date on industry trends and best practices.
• Perform productivity and costing analyses, identifying opportunities to reduce costs and improve efficiency while maintaining high-quality standards.

Requirements:
• Bachelor's degree in an Engineering discipline (Mechanical, Biomedical, etc.).
• Minimum of 10 years of experience in medical device manufacturing with a BS or 8 years with an MS or PhD degree.
• Experience with process validations (IQ-OQ-PQ), Lean Sigma, 6S, and statistical analysis tools (e.g., CPK, DOE).
• Strong written and verbal communication skills, with the ability to create and deliver presentations.
• Advanced skills in software applications such as Microsoft Office and Solidworks.
• Expertise in data analysis, problem-solving, and design thinking.
• Knowledge of Quality System requirements (e.g., QSRs, ISO, MDD) and the ability to work in a fast-paced environment managing multiple priorities.

  • New Brighton, Minnesota, United States Howmet Corporation Full time

    Job SummaryThis role is responsible for developing and implementing cost-effective manufacturing processes, providing technical support to program management and operations, and coordinating project activities to ensure efficient production. The ideal candidate will have a strong background in manufacturing engineering and experience with CAD/CAM systems and...


  • New Brighton, Minnesota, United States Tactile Medical Full time

    Are you passionate about engineering and eager to launch your career? Tactile Medical's Product Engineering Internship is an ideal opportunity to develop your skills, gain industry experience, and contribute to meaningful projects.During this 11-week internship, you will work closely with the Engineering team to:Develop and implement innovative solutions for...


  • New Brighton, Minnesota, United States Tactile Medical Full time

    Tactile Medical invites ambitious students to apply for its Product Engineering Internship. This 11-week program provides a comprehensive learning experience, including tours of different sites and departments, one-on-one mentorship, and social and community outreach events.Responsibilities:Collaborate with the Engineering team to develop innovative...


  • New Brighton, Minnesota, United States Mytech Partners Full time

    About the RoleMytech Partners is seeking a highly skilled Process Efficiency Analyst to join our team. As a Process Efficiency Analyst, you will play a pivotal role in analyzing and optimizing current processes, driving change management initiatives, and leveraging our scale to enhance team member satisfaction, client success, and overall profitability.Key...


  • New Brighton, Minnesota, United States Verterra Energy Full time

    Job OverviewAt Verterra Energy, we're pioneering a novel modular hydropower technology that captures baseline, zero emission electricity. To achieve this mission, we are seeking a highly skilled Senior Mechanical Engineer to contribute to numerous phases of product design, development, prototyping, manufacturing and operational support.


  • New Prague, Minnesota, United States Electromed Full time

    About ElectromedWe develop, manufacture, and market innovative airway clearance devices that help people around the world breathe better, stay healthier, and lead active and fulfilling lives. Our mission is to make life's important moments possible-one breath at a time.We are committed to fostering a culture of excellence, innovation, and collaboration. Our...


  • New Ulm, Minnesota, United States Disability Solutions Full time

    As a skilled Manufacturing Specialist, you will join the Volt team in New Ulm, MN, working on a contract basis for 12+ months. With a competitive hourly rate of $21-$22.50, this role offers a unique opportunity to develop your skills and expertise in assembly and packaging. Your primary responsibilities will include:• Assembling and packaging manufactured...


  • New Ulm, Minnesota, United States Disability Solutions Full time

    Job DescriptionIn this role as a Manufacturing Assembler, you will be responsible for assembling and packaging manufactured products in a fast-paced production environment. You will work closely with our team to ensure high-quality products are produced efficiently and effectively.About the OpportunityThis contract opportunity offers a competitive pay rate...


  • New Brighton, Minnesota, United States TÜV SÜD America Full time

    Account Executive Role at TÜV SÜD AmericaWe are seeking an experienced Account Executive to join our team and contribute to our mission of delivering exceptional safety and sustainability solutions to our customers.About the Job:This is an excellent opportunity for a sales professional to leverage their expertise in growing sales revenue and expanding...


  • New Ulm, Minnesota, United States 3M Full time

    Your Key ResponsibilitiesDrive safety, quality, service, cost, and employee engagement improvementsOversee day-to-day operations of a production areaEnsure a safe working environment through formal inspections and corrective actionsProvide training and instructions to employees on standard and new operating proceduresMonitor production rates, yields, and...


  • New Ulm, Minnesota, United States Aerotek Full time

    Job DescriptionAerotek seeks a Manufacturing Specialist to join our team in New Ulm, Minnesota. This is a Contract to Hire position offering a competitive salary and excellent benefits. ResponsibilitiesThe ideal candidate will have experience in electronic and mechanical assembly, machine tool operations, and production tooling and fixtures. Key...

  • Project Estimator

    2 days ago


    New Brighton, Minnesota, United States Howmet Corporation Full time

    About the RoleWe are seeking a highly skilled Project Estimator to join our team at Howmet Corporation. As a key member of our engineering department, you will play a critical role in providing accurate cost estimates for manufacturing projects.The successful candidate will have a strong background in engineering and manufacturing processes, with attention...


  • Elko New Market, Minnesota, United States Niagara Bottling Full time

    About the RoleThe Production Supervisor will manage and direct activities of assigned shifts, maintain effective working relationships with team members, and analyze production schedules to meet targets. The ideal candidate will have 4 years of experience in a field or similar manufacturing environment, with a strong understanding of production processes and...


  • New Brighton, Minnesota, United States Creative Financial Staffing Full time

    We are Creative Financial Staffing, a leading staffing agency for the financial sector. We have an exciting opportunity for a highly skilled Regional Accounting Director to join our team.This is a fantastic chance to take on a challenging role that will allow you to develop your skills and experience in financial leadership.The successful candidate will be...


  • New Prague, Minnesota, United States Chart Industries Full time

    About the JobWe are looking for a highly motivated Design and Development Engineer to join our team at Chart Industries. As a Design and Development Engineer, you will be responsible for the design and development of cryogenic systems, including hydrogen products.Company OverviewChart Industries is a global leader in the manufacturing of cryogenic equipment...


  • New Hope, Minnesota, United States Vital Path Full time

    Job DescriptionWe are seeking a highly motivated and experienced New Product Development Manager to join our team. As a critical member of our organization, you will be responsible for developing and implementing innovative solutions that drive business growth and customer satisfaction.The ideal candidate will have a strong background in mechanical...


  • New Brighton, Minnesota, United States Howmet Corporation Full time

    Key ResponsibilitiesDevelop detailed cost estimates for manufacturing projects, including material costs, labor costs, equipment costs, and overheads.Use historical data and industry benchmarks to support estimates and ensure accuracy.Obtain and analyze quotes from suppliers and subcontractors to include in cost estimates.The ideal candidate will possess...


  • New Ulm, Minnesota, United States SpecSys Full time

    **About the Company:**SpecSys is a family-owned company that specializes in providing project management, engineering, and manufacturing services for large mobile equipment. Our team is committed to delivering high-quality solutions, while prioritizing safety and customer satisfaction.About the Job:Develop detailed designs and specifications for mechanical...


  • New Brighton, Minnesota, United States TÜV SÜD America Full time

    About TÜV SÜD AmericaTÜV SÜD America is a global leader in safety and sustainability solutions, serving various industries including ITE, consumer goods, machinery, SEMI, lighting, and laboratory equipment.Job Description:We are seeking an experienced Account Executive to join our team and contribute to our mission of delivering exceptional safety and...


  • New York Mills, Minnesota, United States Brunswick Full time

    Brunswick Corporation is seeking a skilled New York Mills Manufacturing Specialist to join our team. As a key member of our operations team, you will be responsible for performing preventive, routine, and troubleshooting maintenance tasks in our large manufacturing facility.The ideal candidate will have a strong background in skilled trades areas such as...