Senior R&D Project Leader – Regenerative Medicine (Contractor)

Rti Surgical Inc; Eden Prairie (MN); On-site; USD 208,000 - 260,000; Part time

Job summary

Evergen is seeking a Contractor - Senior R&D Project Manager for our Eden Prairie, MN site to lead cross-functional CDMO projects, manage timelines and budgets, and ensure regulatory compliance.

The role requires 5+ years of PM experience, a related bachelor's degree, and PMP preferred. This onsite position offers a 6-month contract with potential conversion, focusing on design transfer, risk management, and client collaboration.

Qualifications

• Bachelor's degree in Material Science, Bioengineering, chemistry or engineering related field.
• 5+ years of project management/technical team leadership experience.
• PMP certification, preferred.

Responsibilities

• Champion and drive execution of CDMO Project Management activities including: milestones, schedules, budgets, resources, status reports, and internal & external communication.
• Prepare project plans, timelines, and budgets.
• Actively manage project timelines and budgets from initiation through completion, ensuring projects are delivered on time and within budget.
• Ensure key stakeholders are informed of project status.
• Manage resource allocation for CDMO projects.
• Actively manage and mitigate project risks and issues.
• Track and communicate KPIs.
• Partner closely with commercial team to assess and to develop client proposals and quotations.
• Ability to quickly assess active projects, establish current status, identify risks, and assume ownership with minimal disruption.
• Build and maintain strong long-term relationships with clients.
• Demonstrate effective communication and interactions with clients, lead tactful and strategic conversations, understand client needs and expectations, and navigate issue resolution.
• Actively engage and collaborate on global cross functional product development teams.
• Medical Device Design Control and Risk Management.
• Prepare documentation in accordance with relevant internal SOPs.
• Author engineering reports and presentations as required to document and communicate results.
• Ensure compliance with regulatory and industry standards (FDA, MDD/MDR, ISO, ASTM, etc.) as appropriate.
• Support sustaining and process engineering efforts during process scale-up and manufacturing improvement initiatives.
• Lead and coordinate design transfer activities to ensure product designs, specifications, manufacturing documentation, and process requirements are effectively transitioned into controlled manufacturing operations.
• Oversee pre-validation manufacturing activities by managing workload, priorities, and cross-functional execution to support development builds, readiness activities, and progression toward validation.
• Other duties as assigned

Skills

Excellent verbal and written

Microsoft Office Suite

Matrix organization

Time management

Adaptability

Medical device industry understanding

Education

Bachelor's degree in Material Science, Bioengineering, chemistry or engineering related field

Job description

Evergen is seeking a Contractor - Senior R&D Project Manager for our Eden Prairie, MN site to lead cross-functional CDMO projects, manage timelines and budgets, and ensure regulatory compliance.

The role requires 5+ years of PM experience, a related bachelor's degree, and PMP preferred. This onsite position offers a 6-month contract with potential conversion, focusing on design transfer, risk management, and client collaboration.