Manufacturing Engineer II

Position Summary:

Individuals in this role will work on a new product launch and sustained support, working cross-functionally with partners from operations, supply chain, and development teams. This position will support the launch and ramp of a new product line, as well as assist with building out the rest of the technical staff to support the production area.

Key Responsibilities:

• Lead various aspects of Operations Readiness as part of launching new products for our organization's Electrophysiology business unit
• Engage with development (Research and Development and Process Development) teams to build knowledge for current state operations and use insight to build plans and execute successful design transfers and ramp.
• Engage with operations (Production and Supply Chain) teams to build ramp plans, new line introduction plans, including equipment ordering, receipt, qualification, and validation.
• Drive cross-functional engagement to support process, product, and equipment improvements.
• Provide guidance and leadership to other engineers and technicians.

• Provide technical mentorship to engineers and technicians
• Conduct Process FMEAs and Process Validations
• Improve product quality, labor efficiency, and throughput through the use of Lean manufacturing concepts
• Coordinate the design, procurement, build, and debug of tooling, machinery and test equipment
• Work with Product Development to ensure Design for Manufacturability
• Provide front-line engineering support for day to day needs of production

• Mechanical, Chemical, Biomedical or any engineering or technical degree or equivalent experience required
• Minimum 3 years of manufacturing engineering experience. Prior manufacturing engineering or process development experience is required.
• Strong analytical, problem-solving solving and project management skills
• Demonstrated leadership capability in team settings
• Ability to lead and motivate peers, drive change, and problem-solve with creativity.
• Ability to travel approximately 15%, including internationally.

• Medical device experience is preferred