Principal Design Quality Assurance Engineer

Boston Scientific Foundation Inc

Waltham, MA, US
Base: $ to $; bonus/equity: not specified; benefit...
On-site
Quality system for medical electrical equipment
Risk management processes for new products
Verification and validation of capital equipment
The Principal Design Quality Assurance Engineer will bring their leadership to new product development projects and sustaining projects for our innovative electrophysiology cardiovascular products portfolio

Job Summary

  • The Principal Design Quality Assurance Engineer will bring their leadership to new product development projects and sustaining projects for our innovative electrophysiology cardiovascular products portfolio.
  • Lead Quality function for product development teams within the BSC Quality System to develop new Medical Electrical Equipment (MEE) and Medical Electrical Systems (MES) as part of a core group of Design Quality Assurance (DQA) Engineers.
  • At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges.

Matching Summary

The Principal Design Quality Assurance Engineer will bring their leadership to new product development projects and sustaining projects for our innovative electrophysiology cardiovascular products portfolio.

Salary

Base: $ to $; Bonus/Equity: Not specified; Benefits: Not specified

Skills & Requirements

Must-have

  • Quality System for Medical Electrical Equipment
  • Risk Management processes for new products
  • Verification and validation of Capital Equipment
  • Compliance to all quality requirements
  • Applied knowledge of statistical concepts

Nice-to-have

  • Leadership, relationship building, team building
  • Mentoring and coaching others
  • Strong communication and presentation skills
  • Software as a Medical Device (SaMD)

Key Requirements

  • Bachelor’s of Science in Biomedical, Electrical Engineering or equivalent
  • 10 years of medical device engineering experience
  • Experience in Medical Electrical Equipment/Systems (MEE / MES)
  • Experience in regulated environments (FDA, ISO, EUMDR, IEC 60601, EN ISO 14971, IEC 62304, EN ISO 13485)
  • Travel approximately 5-10%

Work Rights

Not specified

Tailored Resume

Cover Letter