10 часов назад
R&D Project Manager (Medtech)
150 000 - 180 000$
Мэтч & Сопровод
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Описание вакансии
Текст:
TL;DR
R&D Project Manager (Medtech): Managing the CONNECT digital environment extending the Edison System, including connectivity, remote systems, portals, data capabilities, releases, and field upgrades with an accent on regulated medical-device development, design controls, data privacy, and cross-functional execution. Focus on coordinating software, hardware, quality, regulatory, cybersecurity, and external-partner dependencies, integrating CONNECT releases with the Edison System, and maintaining release readiness across the program.
Location: Hybrid in Plymouth, Minnesota, United States; up to 10% domestic travel. Visa sponsorship is not available.
Salary: $150,000–$180,000 annually
Company
is a commercial-stage medtech company developing the Edison System, a non-invasive histotripsy therapy platform, and expanding its clinical and commercial applications.
What you will do
- Manage the CONNECT operational cadence, including the System DHF, release schedules, status meetings, action tracking, milestones, risks, and resource visibility.
- Coordinate system-level development and verification activities across hardware upgrade kits, sourcing, manufacturing, software configuration, logistics, quality, regulatory, and systems engineering.
- Plan and execute field upgrades, prioritize customer systems, and drive CONNECT portal adoption and internal training.
- Manage customer agreement implementation and global data privacy activities with Legal and Data Privacy teams.
- Coordinate cybersecurity, infrastructure, data management, and integration requirements for each CONNECT release.
- Support portfolio-level tracking, resource planning, dependency mapping, governance, and standardized project reporting.
Requirements
- Bachelor’s degree in computer science, software engineering, electrical engineering, or a related discipline.
- 10+ years of experience in medical devices or other complex, regulated technical product development, including software or connected-systems projects.
- Background as a software developer, software engineering lead, or software project/program manager with experience owning cross-functional, system-level programs.
- Working knowledge of database architecture, medical-device design controls, ISO 14971 risk management, IEC 62304 software lifecycle standards, and verification and validation processes.
- Knowledge of cybersecurity requirements for connected medical devices and experience with project management tools such as MS Project, Smartsheet, Jira, or Azure DevOps.
- Willingness to travel domestically up to 10%.
Nice to have
- PMP, Certified ScrumMaster, PMI-ACP, or an equivalent certification.
- Experience with customer agreements, HIPAA, GDPR, or other data privacy frameworks.
- Experience planning field deployments or upgrades for connected medical devices.
- Familiarity with Azure, AWS, Google Cloud, DevOps, CI/CD, imaging, or multi-modality medical-device programs.
Culture & Benefits
- Work at the intersection of cutting-edge science and real-world medical applications.
- Health, dental, and vision insurance.
- Life, short-term disability, and long-term disability insurance.
- 401(k), paid time off, and other benefits for full-time employees.
- Equal opportunity workplace focused on diversity and inclusion.
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