Process Development Engineer

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

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

• Bachelor's degree in engineering, mechanical is preferred.
• Advanced degree preferred.
• Minimum of 2 years of experience in developing manufacturing processes in the medical device industry.
• Experience with implantable pulse generator assembly preferred.
• Risk analysis – PFMEA.
• 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.

• Full Coverage Medical Benefits – Employee + family contribution is 100% covered by Impulse Dynamics.
• Paid Vacation, floating holidays, and sick time.
• Paid Holidays.
• 401k Match (up to 6%).

Unless specifically indicated communicated otherwise in writing, all employees are "at-will" employees. The Company reserves the right to modify the aforementioned terms with appropriate notice and under no circumstance do the above described compensation and benefits constitute a promise to continue them for the duration of an employee’s employment.

Impulse Dynamics is an equal opportunity employer.

Impulse Dynamics is committed to the spirit and letter of all federal, state, and local laws and regulations pertaining to equal opportunity. To provide equal employment and advancement opportunities to all applicants, employment decisions at the company will be based on merit, qualifications, and abilities. The company does not unlawfully discriminate based on race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, veteran status, genetic information, or other protected status.

This policy extends to all terms, conditions, and privileges of employment, as well as the use of all Impulse Dynamics facilities.