Contractor - Senior R&D Project Manager

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

If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process.

Contractor - Senior R&D Project Manager

Contractor Eden Prairie, MN, US

3 days ago Requisition ID: 2549

Salary Range: $100.00 To $125.00 Hourly

Position: Contractor - Senior Project Manager

Hourly Rate: $100.00-125.00 per hour

Work Arrangement: 100% onsite in Eden Prairie - Monday through Friday, 7am to 4pm

Contract Length: 6 months, with the potential to convert to a full-time position in the future

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.

• 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

REQUIREMENTS

Education

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

Experience

• 5+ years of project management/technical team leadership experience

Certification

• PMP certification, preferred

Skills

• 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.

Travel

N/A

SAFETY

Physical Requirement

• Move or lift objects up to 25 pounds
• Frequent (>75%) stationary position (standing or sitting) while utilizing digital displays
• Frequent (>75%) fine manipulation using hands and fingers (typing, opening, writing, clicking, paper sorting, etc.)

Onsite: Office environment with assigned workstation

More about Evergen:

Evergen provides customers across a diverse set of market segments with leading-edge expertise, scale, and flexibility across end-to-end services including design, development, regulatory support, verification and validation, manufacturing, and supply chain management.

Evergen is rooted in a steadfast commitment to quality, integrity, and patient safety with a focus on five key values:

• Accountable: We own our actions and decisions.
• Agile: We embrace change to stay ahead of the curve and evolve to drive innovation and growth.
• Growth Mindset: We embrace challenges as opportunities for continuous learning.
• Customer-Centric: We prioritize customers at every touch point.
• Inclusive: We thrive on the richness of our diversity and ensure every voice is heard, respected, and celebrated.

At Evergen, we are committed to fostering an inclusive workplace where we embrace the richness of our diversity and ensure that every voice is heard, respected, and celebrated. We believe that by embracing diversity and promoting inclusivity, we not only uphold our values but also strengthen our position as the CDMO of Choice in regenerative medicine solutions. We recognize that cultivating a growth mindset is essential to our success, and we are dedicated to continuous learning and improvement in our diversity, equity, and inclusion efforts. Through accountability and action, we strive to create an environment where individuals can thrive, innovate, and contribute their unique perspectives to drive our collective success.

Montagu Private Equity ("Montagu"), a leading European private equity firm, acquired Evergen in 2020 and has supported the transformation of the company to its next level of potential.