Senior Software Design Assurance Engineer, Medical Devices

Green Key Resources; Burlington (MA); On-site; USD 80,000 - 105,000; Full time

Job summary

A leading medical technology firm is seeking a Senior Design Assurance Engineer I to support quality engineering for medical device software. This mid-senior level position involves managing design control deliverables, risk management, and ensuring compliance with regulatory standards. Ideal candidates should have over 5 years of relevant experience and strong skills in programming languages like C++, Java, or Python. This full-time role is located in Burlington, Massachusetts and offers competitive compensation.

Qualifications

• 5+ years of experience in medical device or semi-regulated industry.
• In-depth knowledge of GMP, ISO 13485, ISO 14971, and FDA requirements.
• Experience in software test protocols and statistical techniques.

Responsibilities

• Support software development for medical devices.
• Assist in software test case review and design documentation.
• Participate in risk management activities and internal audits.

Skills

Medical device manufacturing knowledge

Software development proficiency

Attention to detail

Team collaboration

Documentation skills

Education

Bachelor's degree

Associate's degree in science or engineering

Tools

C++

Java

Python

ERP systems

Job description

A leading medical technology firm is seeking a Senior Design Assurance Engineer I to support quality engineering for medical device software. This mid-senior level position involves managing design control deliverables, risk management, and ensuring compliance with regulatory standards. Ideal candidates should have over 5 years of relevant experience and strong skills in programming languages like C++, Java, or Python. This full-time role is located in Burlington, Massachusetts and offers competitive compensation.