Software Quality & Regulatory Assurance Engineer

Philips; Bedford (MA); On-site; USD 102,480 - 163,968; Full time

Benefits offered by this job

Generous PTO

401k (up to 7% match)

Stock purchase plan

Education reimbursement

Job summary

Philips in Bedford, MA is seeking a Software Design Assurance Engineer to lead quality assurance efforts in FDA regulated medical device software development. The ideal candidate will have over 5 years' experience and a Bachelor's degree in a relevant field, focusing on quality standards and regulatory compliance.

This position requires a full-time on-site presence and offers a salary range of $102,480 to $163,968. Philips provides a generous benefits package including PTO, 401k matching, and education reimbursement.

Qualifications

• 5+ years of experience in FDA regulated medical device software environments.
• Strong understanding of Quality Management Systems (QMS) related to Software Design Controls.
• Ability to interpret software design and code.

Responsibilities

• Lead assessment of software designs to uphold quality and regulatory standards.
• Implement software quality plans and risk management activities.
• Conduct detailed root cause analyses for software quality issues.

Skills

FDA regulated environments

Risk Management (ISO 14971)

Root Cause Analysis

Software V&V

Agile

C/C++/C#

Education

Bachelor's Degree in Quality, Computer Science/Engineering

ISTQB certification (desired)

Job description

Philips in Bedford, MA is seeking a Software Design Assurance Engineer to lead quality assurance efforts in FDA regulated medical device software development. The ideal candidate will have over 5 years' experience and a Bachelor's degree in a relevant field, focusing on quality standards and regulatory compliance.

This position requires a full-time on-site presence and offers a salary range of $102,480 to $163,968. Philips provides a generous benefits package including PTO, 401k matching, and education reimbursement.