Contractor - Senior R&D Project Manager

Evergen•Eden Prairie, MN

8d•Onsite

About The Position

Evergen is a global industry-leading contract development and manufacturing organization (CDMO) in regenerative medicine. As the only regenerative medicine company that offers a differentiated portfolio of allograft and xenograft biomaterials at scale, Evergen is headquartered in Alachua, FL, and has manufacturing facilities in West Lafayette, IN., Eden Prairie and Glencoe, MN., Neunkirchen, DE., Glasgow, UK., and Marton, NZ. This role is a contractor position for a Senior Project Manager, working 100% onsite in Eden Prairie, MN, Monday through Friday, 7am to 4pm. The contract is for 6 months with the potential to convert to a full-time position in the future.

Requirements

Bachelor’s degree in Material Science, Bioengineering, chemistry or engineering related field
5+ years of project management/technical team leadership experience
Excellent verbal and written communication
Microsoft Office Suite
Proven ability to operate in a matrix organization and work effectively with leadership, clients, and across geographic and organization boundaries.
Strong time management and prioritization skills are required for management of multiple projects
Adaptability to rapidly changing priorities.
Thorough understanding of medical device industry.

Nice To Haves

PMP certification

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