Job Description

The primary responsibility of the Senior Process Development Engineer will be to develop, implement and validate manufacturing processes for electronic implantable medical devices. Will also provide oversight and guidance to technicians and engineers developing manufacturing processes.

Responsibilities:

• Develop, implement and validate manufacturing process for implantable electronic medical devices
• Equipment specification, procurement, installation and validation
• Manufacturing fixture/tooling specification, design and procurement
• Manual and semiautomatic assembly
• Laser welding, resistance welding, manual soldering
• Surface treatment, cleaning processes
• Molding
• DOE, range finding
• Cross sections sample analysis
• Process optimization
• Provide technical leadership and mentorship to the engineering team
• Collaborate with cross-functional teams including Supply Chain, Quality, and R&D on product requirements
• Maintain strong relationships with consultants and suppliers
• Maintain thorough documentation of engineering activities
• Establish and adjust work procedures to meet standard policies related to quality.
• Implement processes and workflows that are effective and efficient.
• Track KPIs for team’s performance

Qualifications and Experience:

• Bachelor's degree in engineering, mechanical is preferred.
• Advanced degree preferred.
• Minimum of 5 years of experience in developing manufacturing processes in the medical device industry.
• Experience with implantable pulse generator assembly preferred
• Risk analysis – PFMEA
• Failure analysis
• Design of experiments
• Strong knowledge of FDA regulations, ISO standards, and other relevant medical device regulations.
• Excellent problem-solving skills and attention to detail.
• Strong communication and interpersonal skills.
• Ability to work effectively in a fast-paced, collaborative environment.
• Proficient experience at all levels of the medical device product lifecycle.
• Strong working knowledge of Microsoft Office
• Proficiency with statistical tools, CAD, 3D modeling, Laser/RSW is preferred