Senior Design Assurance Engineer I, Software

Job DescriptionJob Description

Senior Design Assurance Engineer I, Software

Location: Burlington, MA

Schedule: Hybrid (Onsite M/W/F)

Compensation: $82,500 - $107,200 (Exempt)

Bonus: 10% annual target

Equity: 20,000 RSUs

Sponsorship: Available if needed

Overview

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+ )
• 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 (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
• Bachelor’s degree in engineering or science discipline required; alternate education considered with relevant experience
• ERP systems proficiency

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.

Benefits:

med, dental, vision, PTO, holidays, sick days, RSUs Restricted Stock Units

Application Process

Qualified candidates are encouraged to submit a resume highlighting relevant experience and qualifications.

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