Senior Design Assurance Engineer , Software

Senior Design Assurance Engineer I, Software Senior Design Assurance Engineer I, Software

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Senior Design Assurance Engineer I, Software

Location: Burlington, MA

Schedule: Hybrid (Onsite M/W/F)

Employment Type: Full-Time, Exempt

Compensation: $82,500 - $107,200 + 10% bonus + $20,000 RSUs

Relocation Assistance: Available

Sponsorship: Available

Reports To: Sr. Manager, Quality Assurance

About the Role

We are seeking a Senior Design Assurance Engineer I, Software to support full product lifecycle activities related to innovative ocular medical devices. You will focus on design assurance, risk management, and regulatory compliance for software components of medical devices. This includes new development, enhancements, and sustaining engineering efforts.

This is a critical role to support increased development work in our software portfolio and is an urgent hire.

Key Responsibilities

• Support software development for medical devices in collaboration with application developers and product teams.
• Assist in software tool qualification and validation.
• Review software test protocols and results for design verification and validation.
• Participate in risk management activities ensuring compliance with ISO 14971, IEC 62304, and ANSI/AAMI SW96.
• Evaluate and support product design changes.

Quality Systems

• Contribute to engineering change order (ECO) preparation and review.
• Participate in periodic reviews of quality system procedures.
• Support CAPA investigations and follow-up tasks.
• Analyze data trends and help improve quality system processes.
• May assist in internal audits and compliance checks.

Other Duties

• Collaborate across departments including R&D, Operations, Clinical, and Regulatory to support business objectives.
• Take on additional responsibilities as needed.

Required Qualifications

• 5+ years of experience in medical device or a semi-regulated industry (8+ preferred).
• Strong background in software development and design assurance.
• In-depth knowledge of:
• ISO 14971, IEC 62304, ISO 13485, 21 CFR Part 820, EU MDD/MDR, GDPR, IEC 60601
• Proficiency in software development tools and languages (e.g., C++, C#, Python).
• Experience with version control, bug tracking, and automated test tools.
• Experience in software-related risk assessments, CAPAs, and design reviews in a regulated environment.

Education

• Bachelor’s degree in science or engineering required.
• In lieu of a bachelor’s degree, an associate’s degree or upper-level certification in a related field may be accepted.

Preferred Attributes

• Excellent documentation and communication skills.
• Organized, detail-oriented, and able to manage cross-functional coordination.
• Demonstrated leadership potential and strategic thinking.
• Proficient in data entry, ERP systems, and quality/compliance documentation.

Seniority level

• Seniority level
  
  Mid-Senior level

Employment type

• Employment type
  
  Full-time

Job function

• Job function
  
  Engineering, Science, and Quality Assurance
• Industries Pharmaceutical Manufacturing, Biotechnology Research, and Medical Equipment Manufacturing

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Inferred from the description for this job

Medical insurance

Vision insurance

401(k)

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