Senior Compliance Engineer (24-57) - IPG Photonics
Marlborough, MA 01752
About the Job
Thank you for your interest in positions at IPG Medical. 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!
IPG Medical, a wholly owned subsidiary of IPG Photonics (NASDAQ: IPGP), is focused on developing next-generation products based on IPG Medical’s state-of-the-art laser technology. Headquartered in Marlborough, MA, we aspire to work together with our employees and customers to apply light in ways that improve life.
IPG Medical, a wholly owned subsidiary of IPG Photonics (NASDAQ: IPGP), is focused on developing next-generation products based on IPG Medical’s state-of-the-art laser 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.
The ideal candidate is a diligent, hardworking individual who is willing and able to learn new skills and technologies to ensure the IPG Medical team achieves its mission.
Job Function:
- Support risk analysis activities, including risk management plans, hazard analysis, FMEA, and risk management reports
- Monitor the status of relevant international standards, and provide guidance on present and future regulatory testing requirements
- Support pre-compliance testing and mitigation of new and modified designs
- Interact with third-party test houses that conduct compliance testing of IPG products. This includes creation of EMC test plans, checklists, documentation packages, on site test support, test report reviews.
- Assist regulatory department with FDA, CE, and other regulatory submissions
- Perform all other essential duties as assigned
Requirements:
- 10+ years of experience with engineering and development of Class II electro-mechanical medical devices
- Knowledge of standards and regulations such as ISO 14971, IEC 60601-1, 60601-1-2, 60601-1-6, 60601-2-22, 60825-1, 62366, 62304, ETSI EN 301 489, 21 CFR 1040.10, 1040.11
- Knowledge of Design Controls, regulations and standards such as FDA QSR's, and ISO 13485 is preferred
- Knowledge of EMC/EMI mitigation techniques
- Supporting medical device compliance testing (e.g. EMC, EMI, and Safety) with external test houses, such as TUV an Intertek. Including EMC Test Plans, Safety Checklists, and documentation packages
- Knowledge of technical design and risk management documentation, such as design specifications, verification/validation protocols, risk management plans, hazard analysis, FMEA, and risk management reports
- 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
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
Equal Opportunity Employer / Affirmative Action M/F D/V
IPG Photonics Corporation is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans. All employment decisions and personnel actions at IPG Photonics are administered without regard to race, color, religion, creed, national origin, ancestry, sex, age, qualified mental or physical disability, gender identity, sexual orientation, genetic carrier status, any veteran status, any military service, any application for any military service, or any other category or class protected by applicable federal, state or local laws. IPG Photonics Corporation provides reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Assistance Act of 1974 and Title I of the Americans with Disabilities Act of 1990. Applicants who need accommodation in the job application process should contact (508) 506-2527 or email HR.Accommodations@ipgphotonics.com to request assistance. Please note that only those inquiries concerning a request for reasonable accommodation will be responded to.
Source : IPG Photonics