Serve as a key quality representative in the Neuromodulation Software and Firmware product development team, ensuring software and firmware meet regulatory, reliability, and quality standards throughout the product lifecycle in a highly regulated medical device setting.
Responsibilities
- Collaborate with a team of Product Software Quality Assurance Engineers to support quality initiatives.
- Participate in all phases of software and firmware quality assurance within a regulated environment for active implantable and capital equipment medical devices.
- Validate software and firmware requirements, security controls, and compliance with applicable regulatory standards.
- Support end-to-end development activities across the product lifecycle, from initial requirements to product retirement.
- Develop and execute design validation plans, protocols, and reports, including system-level testing, while documenting and escalating issues.
- Review design, development, and testing processes to ensure alignment with quality and regulatory expectations.
- Evaluate and approve critical documentation such as user requirements, hazard analyses, risk assessments, design specifications, test protocols, and traceability matrices.
- Assist in validating Automated Test Equipment (ATE) used in testing processes.
- Support Corrective and Preventive Action (CAPA) processes related to software quality.
- Conduct comprehensive design validation reviews covering user needs, functional specs, code reviews, unit and integration testing, black-box and white-box testing, test automation, exploratory testing, cybersecurity, usability, risk management, FMEAs, and hazard analysis.
Requirements
- Bachelor of Science degree in Computer Science, Software Engineering, Electrical Engineering, Biomedical Engineering, or a related engineering field.
- At least five years of professional experience in software quality assurance or a similar role.
- Familiarity with software testing methodologies and processes.
- Hands-on experience performing manual system-level testing in a regulated environment.
- Knowledge of Software Development Life Cycle (SDLC) practices as defined by IEC 62304.
- Some programming experience with languages such as C#, C++, Swift, Node.js, Java/JavaScript, Python, LabView, or platforms including Cloud, Windows, iOS, and Android.
Nice to Have
- Master of Science degree in Computer Science or Software/Electrical Engineering.
- Strong organizational abilities and effective verbal and written communication skills.
- Team-focused with solid interpersonal skills and a proactive, positive approach.
- Detail-oriented mindset with a commitment to embedding quality into product development.
- Prior experience in the medical device industry or another highly regulated sector.
- Basic understanding of Neuromodulation principles from academic study.
- Experience with CAPA processes, complaint investigations, and external audits.
- Knowledge of risk management practices according to ISO 14971.
- Familiarity with premarket and postmarket cybersecurity standards, including IEC 81001-5-1.
- Understanding of Bluetooth technology and its application in medical devices.
- Experience in mobile application development.
- Awareness of data privacy regulations such as HIPAA and GDPR.
- Certification as an ASQ Certified Quality Engineer (CQE) or Certified Software Quality Engineer (CSQE).
Tech Stack
C#, C++, Swift, Node.js, Java, JavaScript, Cloud, Windows, iOS, Android, Python, LabView, IEC 62304, ISO 14971, IEC 81001-5-1, Bluetooth, HIPAA, GDPR
Benefits
- Access to up-to-date tools, training, and technical resources.
- Support for career growth and skill development.
- Eligibility for employee benefits; details available at bscbenefitsconnect.com.
- Annual bonus targets and long-term incentive opportunities for eligible roles.
- Variable pay components such as overtime and shift differentials for non-exempt positions.
Compensation
The expected pay range is $89,200 to $169,500 per year, based on experience and training. Hiring typically occurs within the middle of this range. Long-term incentives are available for eligible exempt roles. Annual bonus targets depend on plan eligibility and performance criteria.
Work Arrangement
Hybrid – requires presence in the Neuromodulation division office at least three days per week; specific location not disclosed.
Team
Part of a team of Product Software Quality Assurance Engineers within the Neuromodulation Software and Firmware product development group.
- Diversity
- Innovation
- Caring
- Global Collaboration
- Winning Spirit
- High Performance
- Inclusion, equality, and opportunity for all
- Advancing science for life
- Transforming lives through innovative medical solutions
Additional Information
- This is a 2-year fixed-term contract position.
- Visa sponsorship is not available for this role at this time.
- Relocation assistance is not provided.
- The position is classified as safety-sensitive, requiring a prohibited substance test as part of the hiring process.
- Some U.S.-based roles may require proof of COVID-19 vaccination.
