IPG Photonics

Design Assurance Engineer

IPG Photonics • $88K — $105K *
Marlborough, MA 01752In-Person
Healthcare
Less than 5 years of experience
Today
Be an Early Applicant
Job Overview by Ladders

Qualifications

  • Bachelor's Degree in scientific or engineering field; electrical engineering preferred
  • 3-5 years of experience with Class II electro-mechanical medical devices
  • Knowledge of Design Controls and Risk Management practices
  • Experience with regulatory submissions (FDA, CE)
  • Familiarity with compliance testing through external test labs
  • Proficiency in advanced statistical methods and tools like Minitab
  • Strong skills in Microsoft Word and Excel

Responsibilities

  • Conduct product design control for new and existing products
  • Support risk analysis activities such as design FMEA
  • Assist in validation and verification efforts, including software validation
  • Develop Design History and Technical Files in collaboration with Design Engineering
  • Engage with third-party test houses for compliance testing
  • Aid regulatory department with submission processes for medical devices
  • Perform additional duties as assigned

Benefits

  • Opportunity to work on cutting-edge Class II medical devices
  • Collaborative work environment with cross-functional teams
  • Engagement in the entire product development lifecycle
  • Professional growth with exposure to regulatory compliance processes
  • Possibility to contribute to innovative testing methods and processes
Full Job Description
  • 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


  • Bachelor's Degree in scientific or engineering field; electrical engineering is preferred
  • 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, 62366, and 62304 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

About IPG Photonics

IPG Photonics is a leading developer and manufacturer of high-performance fiber lasers and amplifiers for diverse applications in numerous markets. IPG Photonics' diverse lines of low, medium and high-power lasers and amplifiers are used in materials processing, communications, entertainment, medical, biotechnology, scientific and advanced applications.
Learn more about IPG Photonics
Size
6,580 employees
Market Cap
$4.4 billion
Industry
Manufacturing & Automotive
Net Income
$159.5 million
Founded
1990
5 Year Trend
+7.7%
Revenue
$1.2 billion
NASDAQ
IPGP
* Ladders Estimates

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