Senior Process Development Engineer
Gateway Recruiting, Philadelphia, PA, United States
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
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