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.
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
3-5 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, and 62366, is preferred
Supporting medical device compliance testing (e.g. EMC, EMI, IEC) with external test houses, such as TUV an Intertek
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
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
IPG Photonics Corporation