Scrum-Certified Project Manager - Medical Device R&D Focus
Irvine, CA
Schedule: Standard Office Hours
Duration: 16-18-month contract
Pay Range: $52-57.50/hr, depending on experience
Seeking an experienced, certified Scrum Project Manager with a strong background in managing medical device development projects. This role is best suited for candidates with hands-on experience in physical device R&D, especially within cardiovascular products, and who can effectively lead projects using Agile methodology in a highly regulated environment.
Key Responsibilities:
In this role, you will manage cross-functional teams and oversee the product lifecycle from planning through to development. Key responsibilities include:
- Develop a high-level integrated milestone plan for projects, managing scope, quality, schedule, cost, and contracts. Use MS Project and MS Planner to ensure project plans and schedules meet business requirements.
- Serve as Scrum Master, collaborating with R&D and product teams to manage and coordinate sprints using Agile methodology. Facilitate sprint planning, daily stand-up meetings, sprint reviews, and track sprint metrics.
- Apply a modified Scrum framework tailored for physical device development, ensuring compliance with quality systems and regulatory standards. Lead intensive planning sessions to establish a product backlog and align project milestones.
- Establish and maintain strong relationships with internal and external stakeholders, managing expectations and communication effectively throughout the project lifecycle.
- Ensure projects meet Design Control requirements in line with the Edwards Quality System. Manage the Design History Files within the document system and coordinate preparations for technical and design control phase gate reviews.
Technical Skills and Tools:
- Proficient in Excel for data tracking and analysis. Familiarity with MS Project and MS Planner is required for project scheduling and tracking.
- Experience with Windchill or similar PLM software is required to manage and document design control.
- Must have proven experience adhering to Agile principles and processes within the context of physical device development.
Education & Experience:
- Bachelor's degree in Engineering (preferred) or a related field.
- Minimum of 5 years of project management experience in the medical device or pharmaceutical industry.
- Certified Scrum Master with strong Agile methodology expertise.
- Direct experience in physical device development is essential; candidates with only software development experience will not be considered.
Skills & Competencies:
- Excellent problem-solving, organizational, analytical, and critical-thinking skills.
- Strong leadership and influence abilities; capable of driving cross-functional teams to achieve project goals.
- Outstanding documentation, communication, and interpersonal skills, with attention to detail.
- Demonstrated experience in regulated environments, specifically medical device development, is preferred.
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