Job Description
What You’ll Do (Responsibilities)
Lead and manage a team of software engineers delivering medical device software solutions.
Own Agile delivery execution, including sprint planning, tracking and on-time delivery.
Drive end‑to‑end software development lifecycle (SDLC) execution in a regulated environment.
Provide technical leadership across design, implementation, verification, validation, and sustainment.
Partner with software architects to ensure scalable, secure, and clinically safe solutions.
Ensure compliance with FDA regulations and medical device standards (IEC 62304, ISO 14971, IEC 62366, FDA cybersecurity guidance).
Enforce strong documentation, traceability, verification, and audit readiness practices.
Collaborate cross‑functionally with Product Management, Quality, Regulatory, Cybersecurity, Manufacturing, Support, and Implementation teams.
Recruit, mentor, and develop engineers; conduct performance reviews and career coaching.
Champion responsible use of Generative AI tools (e.g., End-to-end Agentic (Copilot or Claude) pipelines including design, coding, test generation, documentation).
Balance delivery speed, quality, technical debt, and patient safety priorities.
What You Bring (Qualifications)
Bachelor’s degree in Computer Science, Software Engineering, or related field.
8+ years of software development experience, including people management.
Proven experience delivering in a healthcare OR medical device software Or from a regulated environment.
Strong hands‑on understanding of:
Agile / Scrum development
Regulated SDLC and design controls
Risk management and verification & validation (V&V)
Technical depth to credibly guide architecture and design discussions.
Experience leading cross‑functional teams in complex product environments.
Hands‑on experience with Generative AI tools supporting development workflows (coding, testing, documentation, defect analysis).
Nice to Have
Experience with clinical systems and/or cath lab software.
HL7 integrations, client/server or on‑prem medical systems experience.
Experience supporting FDA submissions, audits, inspections, or field actions.
Prior leadership in AI‑assisted development pipelines.
Why Join Us
Build software that directly impacts patient care and clinical outcomes.
Lead a high‑visibility, regulated medical device product.
Apply modern GenAI‑enabled engineering practices in a safety‑critical environment.
Collaborate with passionate and experienced engineers, clinicians, and product leaders.
Compensation
The salary range provided in this job posting is intended to reflect the general market value for the position. The actual salary offered may vary based on factors such as the candidate’s experience, qualifications, skills, and the specific requirements of the role. This range may also be subject to change as market conditions evolve. We encourage open communication throughout the interview process to discuss compensation expectations. For base-salary + commission sales roles, the range represents On-Target Earnings.
Min – Max :
$155,324.00 - $232,986.00 (USD)
Benefits
The benefits described represent the current offerings at our organization, however, benefits are subject to change and may vary by location and employment status. We strive to provide a comprehensive benefits package that supports our employees’ health, wellness, and financial goals. Please note that benefits may be discussed in more detail during the hiring process.
Remote first / work from home culture
Flexible vacation to help you rest, recharge, and connect with loved ones
Paid leave benefits
Health, dental, and vision insurance
401k retirement savings plan
Infertility benefits
Tuition reimbursement, life insurance, EAP – and more!
It is the policy of Merative to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Merative will provide reasonable accommodations for qualified individuals with disabilities.
Merative participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here: http://www.uscis.gov/e-verify/employees
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