1 день назад
R&D Program Manager (Enterprise Software)
103 600 - 176 400$
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Описание вакансии
Текст:
TL;DR
R&D Program Manager (Enterprise Software) (MedTech): Leading complex enterprise software programs for regulated medical device products with an accent on program governance, risk management, cloud and on-premises deployments, and regulatory compliance. Focus on coordinating cross-functional delivery, managing software verification and validation, and commercializing secure, quality-compliant platforms.
Location: US Remote. Preference is given to candidates located in Massachusetts and the Northeast region.
Salary: $103,600–$176,400 annually, with eligibility for discretionary bonuses and other incentive plans depending on the role.
Company
develops medical technology and enterprise software solutions supporting healthcare and medical device operations.
What you will do
- Lead complex enterprise software development programs for regulated medical device products from concept through commercialization.
- Plan and manage scope, schedules, budgets, resources, critical paths, risks, dependencies, and program metrics.
- Coordinate architecture, infrastructure, validation, deployment, and release activities across cloud-based and on-premises platforms.
- Establish governance structures and collaborate with Software Engineering, Quality, Regulatory Affairs, Cybersecurity, Product Management, Clinical, and Operations stakeholders.
- Ensure software verification, validation, traceability, documentation, Design History File deliverables, and release readiness.
- Drive process standardization and continuous improvement using Lean, Six Sigma, dashboards, KPIs, and lessons learned.
Requirements
- Bachelor’s degree required; engineering, computer science, or another technical discipline preferred.
- 7+ years of program or project management experience leading complex software development programs in medical devices, digital health, or regulated healthcare technology.
- Experience managing enterprise software programs supporting regulated medical device products; Class II or Class III device experience is preferred.
- Experience with both cloud-based deployments, including AWS, Azure, or GCP, and on-premises software environments.
- Strong knowledge of SDLC, Agile, DevOps, software verification and validation, cybersecurity, and regulated quality systems, including FDA QSR, IEC 62304, ISO 13485, and ISO 14971.
- Strong executive communication, presentation, stakeholder management, and cross-functional leadership skills.
Nice to have
- SaaS and connected medical device platform experience.
- Lean Six Sigma Green Belt or Black Belt certification.
Culture & Benefits
- Remote work arrangement within the United States.
- 401(k) with up to a 6% employer match and no vesting period.
- Employee stock purchase plan and potential long-term incentive plan participation.
- Flexible time off for salaried employees, paid sick time, holidays, parental leave, and disability insurance.
- Tuition reimbursement and health and welfare benefits, depending on location and eligibility.
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