Senior Design Assurance Engineer I, Software

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

Senior Design Assurance Engineer I, Software

This position supports the Quality Engineering (QE) staff for the full product lifecycle of ocular medical device development. Responsibilities include execution of design control deliverables, risk management activities, Design History File compliance, and supporting assessment/implementation of design changes to already approved medical devices. This role supports development of new product software designs as well as maintenance and enhancements of existing products from the software perspective.

Base pay range

$80,000.00/yr - $105,000.00/yr

Additional compensation types

RSUs

Responsibilities

• Under general managerial supervision/oversight, works with development teams in the following areas:
• Work with application developers and product teams to support the development of medical devices with software.
• Support the development and qualification of software development tools and services
• Assist in the review of the software test cases and test runs in support of design verification/validation activities
• Review Software Design Documentation
• Support in risk management activities for effective product development and operational activities ensuring compliance with ISO 14971, IEC 62304, ANSI/AAMI SW96.
• Support changes to product designs.
• Assist in engineering change order preparation/review
• Assist in quality system procedures periodic review
• Assist QE CAPA owners on CAPA task follow up.
• Assess and improve quality system processes through data monitoring and trend analysis.
• May participate in internal audits, conducting audits.
• Other duties as assigned to facilitate R&D, Operations, Production, Engineering, Clinical and Regulatory goals and objectives.

Experience

5+ years of medical device experience or experience in a semi-regulated industry is required; 8+ years preferred.

Knowledge, Skills and Abilities

Strong knowledge of medical device manufacturing and software development.

• In-depth knowledge of GMP, ISO 13485 (note: original text indicated ISO 13845), ISO 14971, EU MDD/MDR, GDPR, and 21 CFR Part 820 FDA requirements, ISO 62304 and IEC 60601 software requirements.
• Expertise in medical product quality assurance (including the requirements for test protocols and statistical techniques).
• Proficiency in programming languages such as C++, Java, or Python, and experience with software development tools (version control, bug tracking, automated testing).
• Excellent documentation skills, attention to detail and accuracy.
• Team player with good written and oral communication.
• Organized with the ability to coordinate activities with internal departments and outside vendors.
• Establishes reputation as an emerging leader with sustained performance.
• Demonstrates strategic thinking and commercial/industry understanding in functional projects.
• Proficient data entry and typing skills.
• ERP systems experience required.

Education

Bachelor’s degree required. In lieu of a Bachelor’s degree, an Associate's degree or upper education certification program in a science or engineering field is acceptable.

Senioriority level

Mid-Senior level

Employment type

Full-time

Job function

• Engineering and Quality Assurance

Industries

• Biotechnology Research
• Pharmaceutical Manufacturing
• Medical Equipment Manufacturing