Medical Software Quality & Regulatory Engineer

Philips; Bedford (MA); Hybrid; USD 102,000 - 164,000; Full time

Benefits offered by this job

Total Rewards benefits

Generous PTO

401k match

HSA

Stock purchase plan

Education reimbursement

Job summary

Philips in Bedford, MA is seeking a Software Design Quality Engineer to lead software quality documentation, reviews, and regulatory submissions. You will drive software risk management, validation, and lifecycle compliance across design controls and post-market monitoring.

The role requires 5+ years in FDA-regulated medical software, strong RCAs, and ability to work in an office-based setting with in-person collaboration. Onsite role in Bedford, MA.

Qualifications

• Minimum 5+ years in FDA-regulated, IEC 62304 medical device software environments.
• Experience with software design assurance/control, risk management, SDLC, and QMS for software design.
• Proven RCAs, software V&V, design traceability and quality tooling.
• Ability to interpret software design and code in languages like C/C++/C#.

Responsibilities

• Lead assessment of software designs using test and performance data.
• Apply and improve software design control, risk management, and systems validation.
• Track and risk assess software anomalies pre- and post-market.
• Conduct root cause analyses for quality issues and validate usability, reliability, and performance.
• Author/test protocols, generate reports, and ensure regulatory planning and filings.

Skills

Software Design Assurance

Risk Management

Regulatory Compliance

Root Cause Analysis

Software V&V

Agile / SAFe

C/C++/C#

Communication Skills

Education

Bachelor’s Degree in Quality/CS/Engineering

Tools

ISTQB certification

Job description

Philips in Bedford, MA is seeking a Software Design Quality Engineer to lead software quality documentation, reviews, and regulatory submissions. You will drive software risk management, validation, and lifecycle compliance across design controls and post-market monitoring.

The role requires 5+ years in FDA-regulated medical software, strong RCAs, and ability to work in an office-based setting with in-person collaboration. Onsite role in Bedford, MA.