Project Manager (ISIJP)

Amicis Global

Job Location:

Sunnyvale, CA - USA

Monthly Salary: Not Disclosed

Posted on: 30+ days ago

Vacancies: 1 Vacancy

Job Summary

Job Title: Project Manager

Location: Sunnyvale CA 94043 - Hybrid

Duration: 6 Months

Position Summary:

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:

Bachelors or Masters 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 preferred.
Experience with project management tools (JIRA MS Project Confluence etc.).

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Job Title: Project Manager Location: Sunnyvale CA 94043 - Hybrid Duration: 6 Months ...