Job Details

1. Can you please confirm your top 3 skills sets required?
   1. Process Development: DOE, problem solving, process improvement and validation
   2. Medical device experience or other regulated industry (aerospace, nuclear, etc.)
   3. Minimum technical background (engineering/science degree or experience), laser welding experience preferred, IPG ideally
2. Can you please confirm the 3 main responsibilities/day to day activities required for this role?
   1. Collaborate with cross functional support members and operations representatives to understand and execute on project scope and timeline
   2. Lead and own critical welding process documentation, including control plans, process instructions, validation protocols/reports, and engineering change orders
   3. Execute validation work for process qualification, including running processes, data analysis, and report documentation
3. What products (if any) will this role support?
   1. CRM pacing and defibrillation devices
4. What is your target years of experience?
   1. 5+ years

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As a Sr Process Engineer in the Advanced Manufacturing Engineering (AME) Joining/Welding group, you will play a key role in developing, optimizing, and scaling the joining and welding processes that enable safe, reliable, and cost-effective medical device manufacturing for the company’s portfolio of cardiovascular and neurological products. You will collaborate closely with design engineering, operations, quality, and supplier partners to launch new products and continuously improve existing lines, with a focus on laser and resistance welding applications.

A Day in the Life

• Design, develop, and qualify robust joining and welding processes (e.g., laser, resistance, micro?welding) for new and existing products, in alignment with AME’s mission to lead process development for project launches.
• Lead process improvement and cost?reduction projects using structured problem?solving and DMAIC principles to improve yield, throughput, and process capability.
• Own critical welding process documentation, including control plans, process instructions, validation protocols/reports, and engineering change orders.
• Partner with manufacturing representatives to transfer processes from development to production, ensuring smooth ramp?up, training, and long?term sustainability.
• Characterize and optimize welding parameters through DOEs, capability studies, and data analysis, leveraging statistical tools to drive evidence?based decisions.
• Collaborate with equipment vendors on specification, selection, installation, and qualification of welding and joining equipment and fixtures.
• Support nonconformance investigations and CAPA activities related to welding/joining processes, driving root cause analysis and durable corrective actions.
• Contribute to a culture of continuous improvement, safety, and compliance with quality and regulatory requirements (including ISO 13485 and FDA expectations).

Must?Have: Minimum Requirements

• Bachelor’s degree in Engineering (Mechanical, Welding, Materials, Biomedical, etc) or related field (Materials Science, Physics, etc).

·         5+ years of relevant engineering experience in manufacturing, process, or advanced manufacturing engineering; or 3+ years with an advanced degree.

• Hands?on experience with at least one of the following: battery or capacitor manufacturing, laser welding, resistance welding, micro?joining, or similar thermal joining processes.
• Demonstrated experience applying structured problem?solving (e.g., DMAIC, root cause analysis, 5 Whys, fishbone).
• Ability to interpret engineering drawings and specifications, and to work effectively with cross?functional teams in a regulated environment.

Nice to Have

• Experience in medical device, pharmaceutical, automotive, or other highly regulated industries.
• Prior work with laser systems, welding equipment, or automated joining cells, including equipment selection and qualification.

·         Familiarity with automation, robotics, vision systems, or custom equipment for joining/welding.

• Knowledge of design for manufacturability (DFM), design of experiments (DOE), and statistical analysis tools (Minitab or similar).
• Familiarity with quality systems and regulations (ISO 13485, FDA QSR, GMP).
• Experience supporting new product introductions and transferring processes from development to production.
• Exposure to Lean, Six Sigma, or formal continuous improvement programs (Green Belt or higher preferred).