Job description
Thank you for your interest in positions at IPG Photonics.
All Applicants must apply on our company website to be considered. Please visit www.ipgphotonics.com and click on the “Company” tab. We look forward to seeing your application soon!
Job Description
Responsible for contributing to the design, development and management of projects for new and legacy products, with a focus on Design Assurance activities of medical laser products.
Duties:
- Conduct product design control activities for new and sustaining product development efforts
- Support risk analysis activities, including design and process FMEA
- Support Process/Design Validation/Verification activities, including software validation and IQ/OQ/PQ activities
- Support Design Engineering in the creation of Design History and Technical Files
- Interact with third-party test houses that conduct compliance testing of IPG products
- Assist regulatory department with FDA, CE, and other regulatory submissions
- Perform all other essential duties as assigned
Location(s)
225 Cedar Hill Road, Marlborough, Massachusetts 01752
Employment Type
Exempt
Requirements
- 5-10 years of experience with engineering and development of Class II electro-mechanical medical devices
- Knowledge of Design Controls and Risk Management practices, regulations and standards, such as FDA QSR's, ISO 13485, ISO 14971, IEC 60601, 60825, 62366, and 62304 is preferred
- Support medical device compliance testing (e.g. IEC60601: EMC, Safety) on site at external local test houses
- Maintenance of technical design documentation, such as design specifications, verification/validation protocols, and DFMEA/PFMEA.
- Working knowledge of advanced statistical methods (e.g., hypothesis testing, DOE, ANOVA, R&R studies, capability, tolerance interval analysis, power and sample size determinations, etc.), including statistical software tools, such as Minitab, is preferred
- Experience with lasers and optical technologies desired, but not necessary
- Strong working knowledge of Microsoft Word and Excel
Education Required:
- Bachelor's Degree in scientific or engineering field; electrical engineering is preferred
Personal Requirements:
- Excellent oral and written communication, and interpersonal skills
- Must be able to interact with customers, consultants, and suppliers
- Ability to work in an environment with competing priorities is necessary
- Must be able to work in a cross-functional team environment
This position must meet Export Control compliance requirements, therefore a “US Person” as defined by 22C.F.R. §120.15 are required. “US Person” includes US Citizen, lawful permanent resident, refugee, asylee. License exception Technology and software under restriction (TSR) defined in 15 CFR 740.6 may permit person from Country Group B.
The following link will take you to the government site with the list of Country Group B:
https://www.bis.doc.gov/index.php/documents/regulation-docs/452-supplement-no-1-to-part-740-country-groups/file
johnandkristie.com is the go-to platform for job seekers looking for the best job postings from around the web. With a focus on quality, the platform guarantees that all job postings are from reliable sources and are up-to-date. It also offers a variety of tools to help users find the perfect job for them, such as searching by location and filtering by industry. Furthermore, johnandkristie.com provides helpful resources like resume tips and career advice to give job seekers an edge in their search. With its commitment to quality and user-friendliness, johnandkristie.com is the ideal place to find your next job.