Software Design Assurance Quality Engineer

LivaNova; Massachusetts; On-site; USD 100,000 - 150,000; Full time

Job summary

A global medical technology company is looking for a Software Design Assurance Quality Engineer in Massachusetts. The role involves providing technical leadership in software/firmware development for medical devices, focusing on validation and compliance with regulations. Candidates should have over 8 years of relevant experience, along with a strong educational background in engineering. A competitive salary and comprehensive benefits are offered.

Benefits

Health benefits – Medical, Dental, Vision

401(k) Retirement and Savings Plan

Employee Stock Purchase Plan

Flexible Work Schedules

Qualifications

• 8+ years of experience required.
• Proven track record in Quality Engineering roles.
• Ability to present clearly during audits and inspections.

Responsibilities

• Serve as a core team member on software/firmware development teams.
• Lead investigations of software/firmware related complaints.
• Validate software used in manufacturing processes.

Skills

Software/firmware development in medical device industry

Leadership skills

Knowledge of IEC 62304

Understanding of ISO 13485

Strong communication skills

Education

BS in Computer Engineering / Computer Science / Electrical Engineering

Advanced degree or professional certifications

Job description

Software Design Assurance Quality Engineer

Join to apply for the Software Design Assurance Quality Engineer role at LivaNova

LivaNova is a global medical technology company focused on improving patients’ lives with neuromodulation and other therapies. This role focuses on software and firmware development and validation for obstructive sleep apnea neuromodulation therapies, and involves active participation in product and non-product software development efforts.

Job Functions

• Serve as a core team member on software/firmware product development teams, providing technical leadership and direction. Responsible for risk management文件, design control compliance, development of design requirements and architecture specifications, and design verification/validation (including unit and integration testing).
• Chair the change control board within projects for change requests and defects identified during development.
• Provide technical feedback in code reviews.
• Lead investigations of software/firmware related complaints, defects from development or manufacturing nonconformities, and CAPAs to identify root causes and corrective actions.
• Generate and maintain risk management documentation throughout the product lifecycle.
• Lead post-market cybersecurity process by monitoring threats and coordinating with security experts.
• Validate software used in manufacturing processes, ensuring change impact assessments, regulatory compliance, risk assessment sufficiency, and acceptance criteria.
• Collaborate with suppliers as needed during development to support program needs.
• Ensure compliance with software/firmware development and non-product software validation procedures.
• Support regulatory audits as a subject matter expert and coordinate related activities.

Knowledge, Skills And Abilities

• Experience developing software or firmware in the medical device industry with proficiency meeting IEC 62304 requirements.
• Ability to build strong relationships with internal customers (R&D, Clinical, Regulatory Affairs, Operations) to support compliance and audits.
• Understanding of LivaNova device design, manufacturing, function and clinical benefits.
• Maintains up-to-date knowledge in software/firmware development and testing to support new product development and investigations.
• Strong leadership, written and verbal communication skills; ability to prioritize and plan activities.
• In-depth knowledge of relevant regulations (e.g., ISO 13485, 21 CFR Part 820) and ability to ensure proper documentation and compliant approaches.

Education

• BS in Computer Engineering / Computer Science / Electrical Engineering (with software development experience) preferred
• Advanced degree or professional certifications valued

Requirements

• 8+ years of experience
• Proven track record of performance in prior roles and accountability for representing Quality Engineering on project teams
• Ability to present procedural requirements and design deliverables clearly during audits and regulatory inspections

Pay Transparency

• Estimated annual base salary range: $100,000 - $150,000 plus discretionary annual bonus. Pay ranges may vary by location.

Employee Benefits

• Health benefits – Medical, Dental, Vision
• Personal and Vacation Time
• 401(k) Retirement and Savings Plan
• Employee Stock Purchase Plan
• Training & Education Assistance
• Bonus Referral Program
• Service Awards and Employee Recognition
• Flexible Work Schedules

Notice Regarding Diversity and Equality

LivaNova values equality and diversity and is committed to a recruitment process that is fair and free from unlawful discrimination. Our selection process focuses on the key demands/requirements for the role.

Legal and Compliance

Please note: LivaNova does not accept unsolicited resumes from recruiters or agencies without a signed Recruitment Services Agreement. We also advise applicants to beware of job scams and to verify postings at the official careers site.