Senior Software Project Manager Medical Devices / Robotics (Embedded Systems)

Hi,

Hope you are doing well.
My name is Rohen and I represent Vision InfoTech. Let me know if you're interested in the below position.

Role: Senior Software Project Manager Medical Devices / Robotics (Embedded Systems)

Locations: Sunnyvale, CA 3 Days Onsite

Project Duration: 6 Months

Mode of interview: Zoom

Interview Process: 2 Rounds Zoom Including Panel

Pharma industry experience is required

Spotlight Call Notes

• This is a Temp Project Manager role for approx. 6 months covering for someone on maternity leave.
• looking an experience Software Project Manager who can hit the ground running from day one. Project is currently in an active release cycle involving verification and validation.
• Role focuses on the tactical aspects: leading meetings, tracking and reporting, ensuring deliverables are met, managing cross-team dependencies.
• Lead and manage a cross-functional team in the Software Project Management Office (PMO). Take responsibility for project execution, tracking deliverables, maintaining the schedule, stakeholder management, risk and mitigation. Direct involvement in ongoing platform/system releases, including hardware integration and software validation/verification.
• Min 5 years project management experience, in medical devices (at least 2 3 years).
• Must have embedded software development/release experience in the medical device industry. And Embedded software development process familiarity.
• Knowledge of compliance standards is required (FDA 21 CFR Part 820, IEC 62304, ISO 13485, and design control processes); candidates don't need to be experts but should be familiar and have real-world compliance release experience.
• Experience with complex capital equipment development (robotics, large medical capital devices) is a plus.

Job Description:

We are seeking a dynamic and experienced Software Project Manager to lead and coordinate the development of cutting-edge surgical robotic platforms. The successful candidate will be responsible for managing software development lifecycles, ensuring timely delivery, compliance with medical device standards, and collaboration across multidisciplinary teams including but not limited to: product management, software & controls engineers, hardware engineers, clinical design engineers, human factors, regulatory and quality engineering teams.

Key Responsibilities:

• Manage Full Software Development Lifecycle:
• Plan, track, and oversee software project activities from requirements gathering to design, development, testing, validation, documentation, and release.

Cross-Functional Team Leadership:

• Facilitate communication and collaboration among inter-, and intra-project teams (with several cross-functional stakeholders) to ensure project success.

Project Planning & Tracking:

• Develop detailed project schedules, set milestones, allocate resources, monitor progress, and proactively mitigate risks.
• Provide clear communication to the organization on accurate project status, critical path, as well as potential areas of risk

Stakeholder Engagement:

• Serve as the main point of contact for project stakeholders, reporting on project status, challenges, and solutions.

Regulatory Compliance:

• Support the team to ensure deliverables adhere to regulatory standards (e.g., IEC 62304, ISO 13485, FDA 21 CFR Part 820), documentation, and quality system requirements.

Continuous Improvement:

• Explore process improvements and arrive at recommendations for future adoption relevant to best practices in agile, waterfall, or hybrid project management methodologies tailored to medical device software.

Budget & Resource Management:

• Track project budgets, forecasts, and resources to keep projects on target.

Qualifications:

• Bachelor's or Master's degree in Computer Science, Engineering, or related technical discipline.
• 5+ years of project management experience in software development, with at least 2-3 years in medical device or robotics.
• Proven track record leading software projects for medical devices, preferably surgical robotics.
• Solid understanding of software development methodologies (Agile, Waterfall, Hybrid).
• Familiarity with surgical robotic platforms, control software, integration with hardware systems, and surgical workflow.
• Strong knowledge of regulatory requirements for medical software (IEC 62304, ISO 14971, FDA regulations).
• Exceptional communication, leadership, and organizational skills.
• Project Management Professional (PMP) or equivalent certification.
• Experience with project management tools (JIRA, MS Project, Confluence, etc.).

Thanks and Regards,

Rohen Singh

Talent Acquisition Specialist

VISION INFOTECH INC

Phone: .

Email:

368 Main Street, st#3, Melrose MA 02176

E-Verified Company