LivaNova
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.
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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.
#J-18808-Ljbffr