Job Role
:
Senior Design Assurance Engineer
— Medical Device (Onsite —
Arbor Lakes
, MN
)
Contract

Overview:

From development to commercialization, we partner with Pharmaceutical, Medical Device and Biotechnology clients to provide solutions to complex compliance issues. We collaborate with our partners by providing technical
expertise
in Quality, Regulatory Compliance and Manufacturing Science and Technology. Our business mission is to ensure our clients exceed their compliance goals while improving patient health and safety. Visit us at
www.pharmavise.com
and follow us on LinkedIn:
https://www.linkedin.com/company/pharmavisecorp

Our F500 Medical Device client has an exciting opportunity for a
Senior Design Assurance Engineer.

Job Summary:

The Sr Design Assurance Engineer provides focused quality engineering leadership on sustaining design assurance activities.
Design assurance drives the ISO14971 risk management process and the Verification & Validation (V&V) process.
This includes quality plans, risk management plans and reports, hazard analysis, product risk management workbook (user FMEA and design FMEA), sampling systems / procedures and statistical techniques, verification protocols/testing/reports, validation protocols/testing/reports. This role will
be responsible for
supporting risk
document
and post market record review during remediation activities as well as ensuring quality and compliance through post commercialization sustaining activities.

Requirements

Required
Qualifications

• 
  Bachelor’s degree in mechanical, electrical, biomedical engineering, or related discipline

• 
  5+ years of related experience in design assurance, new product development, or related medical device or regulated industry experience

• 
  Understanding of electrical safety standards IEC 60601

• 
  Experience with reliability testing

• 
  Demonstrated
  use of Quality tools/methodologies

• 
  Strong written/verbal communication skills.

• 
  Risk documentation per ISO14971

Preferred Qualifications:

• 
  Experience with class III medical devices
• 
  BS in Electrical Engineering
• 
  Previous
  R&D experience
• 
  Strong knowledge of QSR and ISO standards
• 
  Medical device experience
• 
  ASQ certification