Senior Design Quality Engineer

company banner
The Judge Group, Inc.
Validation, Engineering, FDA, Risk Management, ISO, Microsoft Word, Excel
Full Time

Job Description

Location: Westborough, MA
Salary: Excellent!
Description:
AMAZING PERM OPPORTUNITY! MEDICAL DEVICE COMPANY!

Job 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 products

Assist regulatory department with FDA, CE, and other regulatory submissions

Perform all other essential duties as assigned

Job Requirements:

5-10 years of experience with engineering and development of Class II electro-mechanical medical devices

In-depth knowledge of all phases 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

Managing medical device compliance testing (e.g. EMC, EMI, IEC) with external test houses, such as TUV an Intertek

Authoring and 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

Experience with lasers and optical technologies desired, but not necessary

Strong working knowledge of Microsoft Word and Excel

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

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

Education Required:

Bachelor's Degree in scientific or engineering field; electrical engineering is preferred

Contact:

This job and many more are available through The Judge Group. Find us on the web at www.judge.com


Company Information

Judge is the 12th largest IT staffing firm serving clients across North America and Asia Pacific. Our clients include over 50 of the Fortune 100, fast-growing mid-market companies and some of the most innovative tech startups. We are experts at building high performing business-technology teams that lead digital transformations and technology modernization initiatives that help companies drive change. Every company has unique challenges and goals, and Judge invests in each client relationship to understand and deliver customized solutions that exceed expectations.

Dice Id : cxjudgpa
Position Id : 666444
Originally Posted : 3 months ago

Similar Positions at The Judge Group, Inc.

Senior Design Assurance Engineer
  • Mahwah, NJ
  • 1 day ago
Quality Assurance Engineer
  • Mahwah, NJ
  • 1 day ago
Senior Quality Assurance Engineer
  • Mahwah, NJ
  • 1 day ago
Senior Quality Assurance Engineer
  • Mahwah, NJ
  • 1 day ago
Quality Assurance Engineer
  • Mahwah, NJ
  • 1 day ago
Quality Engineer
  • Eden Prairie, MN
  • 1 day ago
Quality Engineer
  • Eden Prairie, MN
  • 1 day ago
Quality Assurance Engineer
  • Leesburg, VA
  • 1 day ago
Jr. Quality Engineers - QE
  • San Francisco, CA
  • 1 day ago
Quality Assurance Engineer
  • San Jose, CA
  • 1 day ago