Med Device Software QA Engineer - Design

Philips International; Bedford, Northern (MA, KY); On-site; USD 102,000 - 164,000; Full time

Benefits offered by this job

PTO (Generous)

401k match

HSA

Stock purchase plan

Education reimbursement

Job summary

Philips, a health technology company, seeks a Software Design Quality Engineer in Bedford, MA. You will lead design assessments, review test data for safety and regulatory compliance, and drive quality plans across the software lifecycle. Strong experience in FDA/IEC 62304 environments and risk management is required; ISTQB is a plus.

Office-based role with travel possible. Candidate will interpret software design and code (C/C++/C#) to verify requirements, support post-market analytics, and

Qualifications

• Bachelor’s degree in Quality, CS/Engineering required.
• FDA-regulated, IEC 62304 environments preferred.
• Experience in software design controls and risk management.

Responsibilities

• Lead assessment of software designs through data reviews.
• Ensure compliance across the software lifecycle and regulatory filings.
• Perform root cause analyses for software quality issues.
• Develop and implement software quality plans and risk management activities.

Skills

Root Cause Analysis

Risk Management

Software V&V

Regulatory compliance

SDLC

C/C++

Education

Bachelor's degree in Quality, CS/Engineering

Tools

C/C++/C#

Job description

Philips, a health technology company, seeks a Software Design Quality Engineer in Bedford, MA. You will lead design assessments, review test data for safety and regulatory compliance, and drive quality plans across the software lifecycle. Strong experience in FDA/IEC 62304 environments and risk management is required; ISTQB is a plus.

Office-based role with travel possible. Candidate will interpret software design and code (C/C++/C#) to verify requirements, support post-market analytics, and