Job Details

Overview

Project Manager & Scrum Master - PMO -[FDA, medical device, PMP or Scrum Certification mandatory] role at MillenniumSoft Inc. Location: San Diego, CA. Duration: 06 Months. Total Hours/Week: 40. 1st Shift. Employment Type: Contract on W2 (Need US Citizens or GC Holders or GC EAD or OPT or EAD or CPT).

Be among the first 25 applicants (posted 2 weeks ago).

Responsibilities

• As part of the Project Management Organization (PMO) of the Software Technology Solutions (STS) group within the client, develop connected enterprise software solutions, platforms and services and work across the product design process.
• Collaborate across core teams, platforms and business units to gain a holistic understanding of client products and services.
• Lead planning and execution of the development effort by leading one or more Agile/Scrum teams and drive cross-functional readiness for product commercialization.
• Accountability for the market delivery and success of an MMS Solution comprising multiple projects.
• Lead program planning, ensure requirements are clear and driven by customer need and experience; manage scope, schedule and resource projects accordingly.
• Identify and mitigate risks/issues, assign responsibility for mitigation actions, and manage mitigation plans.
• Provide servant leadership as a Scrum Master to development teams; lead technical design and commercial excellence reviews and challenge assumptions to improve results.
• Promote continuous learning, ensure cross-functional and technical lessons are reviewed and disseminated.
• Coordinate with Medical Affairs, R&D, Clinical, Regulatory Affairs, Quality, Manufacturing and Logistics to align timelines and decisions.
• Ensure effective communication with core teams and stakeholders; provide feedback for performance evaluations where appropriate.
• Develop and manage project plans with milestones and task assignments; identify risks early and develop action plans for resolution.
• Serve as primary point of contact for management regarding progress and goals; facilitate cross-functional meetings and resolve performance issues as needed.

Qualifications & Skills

• Bachelor's degree in a related field (MBA preferred but not required).
• 4+ years of experience delivering/leading medium-size programs in global companies, preferably in healthcare organizations; 4+ years leading cross-functional teams on complex programs.
• Demonstrated Project Management knowledge and competencies; effective verbal and written communication with customers, project teams and leadership.
• Experience with SCRUM/Agile/SAFe practices; knowledge of Quality Management System (QMS).
• Familiarity with JIRA, Confluence, TeamCenter, Azure DevOps (ADP).
• Strategic thinking, results-oriented, change management and process improvement; highly organized with strong follow-through.

Education & Experience

• Bachelor's degree in a related field; MBA preferred but not required.
• 4+ years of experience leading cross-functional teams on complex programs; healthcare or medical device/technology industry experience preferred but not required.

Desired Skills & Knowledge

• Understanding of government-regulated environment (FDA), regulatory submission and product commercialization.
• Experience with Software as Medical Device (SaMD) and Medical Device Design controls.
• Understanding of Regulatory standards such as IEC 62304, IEC 60601-1, and documentation per IEC 62304.
• Experience managing Cloud and SaaS programs; working in a functional organization is a plus.

Certifications

• PMP or Scrum Master Certification preferred but not required; healthcare/medical device industry experience preferred but not required.

Special Notes

• Seniority level: Mid-Senior level
• Job function: Engineering and Information Technology
• Industries: Staffing and Recruiting

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