A well-established medical technology company is seeking a Senior Design Assurance Engineer I, Software to join its Quality Engineering (QE) team. This role supports the full product lifecycle of ocular medical devices, with an emphasis on software quality and regulatory compliance. The ideal candidate will possess a strong understanding of medical device standards, risk management, and design controls for both new and existing software products.
Key Responsibilities
Support software design assurance activities throughout the product lifecycle
Review software design documentation for compliance with regulatory standards
Collaborate with development teams to ensure design control and risk management alignment
Evaluate and qualify software development tools and services
Participate in software design verification and validation activities
Ensure compliance with ISO 14971, IEC 62304, and other applicable standards
Support changes to approved medical device software designs
Assist in engineering change orders, CAPA tasks, and internal audits
Monitor quality system performance using data trends and process analysis
Qualifications
Minimum 5 years of experience in medical device or semi-regulated industry (8+ preferred)
Strong knowledge of software development within medical device frameworks
Proficient in ISO 13485, ISO 14971, IEC 62304, IEC 60601, 21 CFR Part 820, GDPR, and EU MDR
Experience with design control and quality assurance practices
Familiarity with programming languages (C++, Java, Python) and relevant tools (e.g., version control, automated testing)
Excellent documentation, communication, and cross-functional collaboration skills
Proven ability to work independently and within project teams
Bachelors degree in engineering or science discipline required; alternate education considered with relevant experience
ERP systems proficiency preferred
Additional Information
This is a full-time, exempt position based in Burlington, MA with a hybrid work schedule (Monday, Wednesday, Friday onsite).
Compensation includes base salary, bonus eligibility, and RSU grant.
Sponsorship available for qualified candidates requiring work authorization support.
Take the leap to a rewarding job that pays you well and that you enjoy.
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