R&D Director

New Today

R&D Director Location:  Eden Prairie, Minnesota 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 : Minimum Bachelor's degree in engineering or scientific discipline Experience: 10+ years of engineering/scientific experience designing or modifying medical devices or implants 5+ years of leadership experience Skills: Excellent verbal and written communication Microsoft Office Suite Customer Relationship Management (CRM) Project Management software New Product Development R&D Budget Management Talent Management Strategic Planning Design Control and Design History Files Travel: Up to 20% of travel may be required SAFETY: Physical Requirements : 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.) Work Environment : Office environment with assigned workstation #LI-Onsite
Location:
Eden Prairie

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