Principal Engineer, Image Control - Marlborough, MA
IPG Photonics, Marlborough, MA, United States
IPG Medical Corporation is focused on developing next-generation medical products based on its state-of-the-art technology. Headquartered in Marlborough, MA, we aspire to work together with our employees and customers to apply light in ways that improve life.
Our mission is to develop innovative medical device laser solutions that make the world a better place. To accomplish this mission, we are committed to attracting and retaining the best talent and an engaged, diverse, and thriving workforce that drives a sustainable future for our company and society.
Working at IPG Medical Group you can expect challenging projects, a motivating and friendly environment, and competitive benefits.
Responsibilities:
- Lead development of complex medical instruments through all development phases from design input through verification and validation to manufacturing transfer stages and in coordination with overall system requirements;
- Assist in developing IP portfolio for these instruments and provide original technical solutions to improve performance, functionality, reliability costs requirements;
- Develop product specification in coordination with marketing, customers, other company departments, and contracted companies.
- Maintain business relationships with 3rd party consultants, contractors, and suppliers. Including correspondence when the quality, timeline, or budget are at risk;
- Sensitivity and awareness of both program budget and product costs including clinical economics.
- Assure products are designed to meet stringent global regulatory requirements of medical devices, such as FDA regulations, ISO 13485, CE mark for medical product and others;
- Assist in development and maintaining of design history file and other documentation to support product regulatory approval and manufacture.
Education requirements
- Bachelor of Science degree in engineering discipline, MS preferred
- Strong knowledge of US and global regulatory requirements for medical devices
- Solid technical planning skills to support "Stage Gate" medical device product development.
Experience requirements
- 10+ years of work experience in research and development designing medical image control systems, with more than 5 years in senior position of supervising technical part of development projects with internal and external teams, development partners and suppliers within a company operated under ISO 13485 and FDA protocol in all phases from design input to transfer to production;
- Innovative approach in development of multi-functional medical instruments including image processing / creating software documentation / writing and understanding software coding with clinical and lab experimentation.
- Coordination of technical development teams, work within strict time schedules and budget boundaries, managing multiple suppliers and development partners, negotiating specifications and technical terms of the projects;
- Successful assembly of documentation to support rapid prototyping for pre-clinical and clinical studies.
- Knowledge of Design Controls and Risk Management practices, regulations and standards, such as FDA QSR's, ISO 13485, EU MDR, ISO 14971, IEC 60601, 60825, and 62366, is preferred.
#IND123
#ZR
Location(s) 225 Cedar Hill Road, Marlborough, Massachusetts 01752, United States Employment Type Exempt