Senior Design Assurance Engineer I, 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

Other Duties

Required Qualifications

Education

Preferred Attributes

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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