Senior Software Quality Engineer (Medical Devices)

TL;DR

Senior Software Quality Engineer (Medical Devices): Develops and maintains software quality standards and procedures for medical device systems, ensuring compliance with regulations like ISO 14971 and IEC 62304. Focus on conducting evaluations, defining quality measures, reviewing designs, and providing verification and validation for complex software systems.

Location: Onsite in Boston, Massachusetts, United States of America

Salary: $102,400.00 - $153,600.00 USD

Company

hirify.global leads global healthcare technology, focusing on alleviating pain, restoring health, and extending life through innovation and engineering.

What you will do

• Develop, modify, apply, and maintain software systems quality operating methods, processes, and procedures.
• Conduct evaluations of software systems activities including requirements, design, development, and testing.
• Define appropriate measures to ensure product quality and ensure compliance with project and contract requirements.
• Review software systems design, change specifications, and plans against contractual and process requirements.
• Provide or direct verification and validation of software system requirements, traceability, and testability.
• Contribute to the completion of work group objectives and advance existing or introduce new technology and therapies.

Requirements

• Baccalaureate degree (or equivalent) with a minimum of 4 years of relevant experience, or an advanced degree with a minimum of 2 years relevant experience.
• Good grasp of Risk Analysis concepts (ISO 14971).
• Good grasp of Medical SW Development concepts (IEC 62304).
• Basic computer hardware architecture knowledge (RAM, ROM, FPGA, firmware).
• Linux & Windows systems knowledge (bootloader, OS startup).
• Experience with performing FMEA (top-down, bottom up) and risk management planning/reporting.
• Must be legally authorized to work in the United States.

Nice to have

• Experience with SW testing.

Culture & Benefits

• Competitive Salary and flexible Benefits Package.
• Health, Dental, and Vision insurance, Health Savings Account, Healthcare Flexible Spending Account.
• 401(k) plan plus employer contribution and match, Short-term disability, Paid time off, Paid holidays.
• Employee Stock Purchase Plan, Employee Assistance Program, Tuition assistance/reimbursement.
• Opportunity to contribute to a global team of 95,000+ passionate people focused on healthcare.