Sr. R&D Project Manager - #249403

Location: West Lafayette, IN

RTI Surgical is now Evergen!

This rebranding reflects our strategic evolution as a leading CDMO in regenerative medicine and comes at the end of a significant year for the business, including the successful acquisitions of Cook Biotech in IN. and Collagen Solutions, MN. Our new brand identity emphasizes our unique positioning as the only CDMO offering a comprehensive portfolio of allograft and xenograft biomaterials at scale.

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.

Read more about this change and Evergen’s commitment to advancing regenerative medicine here: https://lnkd.in/eMSfVJkM ;

Responsibilities

• Leads a high-performing R&D team in the successful on-time execution of the company’s product roadmap from concept through regulatory approval and commercialization
• Translates short- and near-term strategies into tactical plans for achieving goals and objectives and executes and monitors progress against KPIs, including the creation and ownership of department functions or initiatives
• Leads problem-solving or process improvement activities and drives effective implementation of improvements
• Manages the development of engineering studies, design verification protocols, and validation protocols, ensuring the quality and integrity of product development and project management work on the team, including design history file development and risk management documentation
• Ensures that product designs consider and apply the latest regulatory guidance, best practices, and international standards
• Manages R&D performance against department metrics and KPIs, and effectively communicates progress to leadership
• Builds a strong, collaborative relationship with Marketing, Commercial, Quality, Regulatory, Sci Affairs/Clinical, and Operations in ensuring successful execution of NPD projects and other company objectives
• Leads the team by reinforcing department culture, recruiting, onboarding, training, developing career growth opportunities, and giving effective performance feedback
• Works proactively with R&D leaders to optimize systems and processes for the orderly and efficient flow of new product development projects from concept through launch
• Manages fiscal responsibilities for areas of R&D by supporting creation of the annual operating budget, recommending capital expenditures, and monitoring revenues and expenditures throughout the budget cycle
• Supports the commercial team by acting as a subject matter expert, attending industry conferences, engaging with customers in the business development phase, and providing feedback to develop customer requirements with a high level of customer service
• Supports development of the intellectual property portfolio
• Other duties as assigned
  
  

Requirements

Education

• Bachelor’s degree in engineering
  
  

Experience

• 7+ years of industry experience in medical device development preferred
• 5+ years of personnel development/supervisory and management experience directly with engineers
  
  

Skills

• Sufficient background to generally understand medical and biotechnology terminology
• Excellent written and verbal communication skills.
• Proven ability to lead and manage projects against scope, time, and budget
• Proven ability to communicate and work constructively with colleagues to establish and achieve mutual goals
• Proven ability to manage and develop scientists and engineers
  
  

Travel

• Less than 20% travel
  
  

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.)
  
  

Working Environment

• 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 RTI in 2020 and has supported the transformation of the company to its next level of potential.