Senior Manufacturing Engineer

• Responsible for leading manufacturing engineering activities focused on catheter manufacturing processes, yield improvement, process optimization, and new product introduction.
• The role involves driving continuous improvement initiatives, supporting production scale-up, and ensuring compliance with medical device quality and regulatory standards.

Requirement/Must Have:

• Bachelor s degree in Mechanical, Chemical, Biomedical, or related engineering discipline or equivalent experience.
• Minimum five years of manufacturing engineering experience in manufacturing or process development.
• Strong analytical, problem-solving, and project management skills.
• Demonstrated ability to work in cross-functional team environments.
• Ability to lead initiatives and drive process improvements.
• Strong communication and collaboration skills.
• Ability to travel up to 25 percent, including international travel.
• Experience in medical device manufacturing.

Experience:

• Experience in catheter or medical device manufacturing processes.
• Experience supporting new product introduction and process scale-up.
• Experience in yield improvement and manufacturing process optimization.
• Experience working in regulated environments such as FDA and ISO 13485.
• Experience in root cause analysis and structured problem-solving methodologies.

Responsibilities:

• Lead yield improvement initiatives across catheter manufacturing processes including reflow, assembly, soldering, bonding, and packaging.
• Apply structured problem-solving methods such as DMAIC, Root Cause Analysis, and A3 to resolve manufacturing issues.
• Analyze manufacturing data to identify trends and process improvement opportunities.
• Serve as technical subject matter expert for catheter manufacturing processes and equipment.
• Coordinate design, procurement, build, and debugging of tooling and test equipment.
• Support new product introduction and technology transfer from R&D to manufacturing.
• Collaborate with Quality, R&D, Supply Chain, Operations, and Regulatory teams.
• Ensure compliance with FDA, ISO 13485, GMP, and internal quality systems.
• Provide technical guidance during investigations and process improvement initiatives.
• Lead cross-functional project teams and drive accountability for deliverables.
• Mentor and coach junior engineers and technicians.

Should Have:

• Experience in pilot builds and ramp-to-production environments.
• Experience leading cross-functional manufacturing improvement projects.
• Strong leadership and mentoring capabilities.
• Ability to work in fast-paced manufacturing environments.
• Strong attention to detail and data-driven decision-making mindset.

Skills:

• Manufacturing process engineering.
• Yield improvement and process optimization.
• Root cause analysis and problem solving.
• New product introduction (NPI).
• Medical device manufacturing processes.
• Data analysis and process capability improvement.
• Cross-functional collaboration.
• Project management and leadership.
• Regulatory compliance (FDA, ISO 13485, GMP).

Qualification And Education:

• Bachelor s degree in Mechanical, Chemical, Biomedical, or related engineering field required or equivalent experience.