R&D Principal Engineer

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

• Champion new product development projects: researching, developing, and securing regulatory approval for new regenerative medicine products.
• Actively engage and collaborate on global cross functional product development teams.
• Medical Device Design Control and Risk Management.
• Project management as necessary.
• Plan, schedule and coordinate project tasks and activities.
• Utilize structured problem-solving approaches to resolve design investigations during development.
• Provide mentorship.
• Conceptualize new devices, techniques, and technologies using material knowledge and innovative design.
• Prepare documentation in accordance with relevant internal SOPs.
• Work closely with product development team to establish product development goals while ensuring market compatibility.
• Grow the company’s IP & patent portfolio through strategic internal research.
• Ability to interface with physicians on product design and use.
• Author engineering reports and presentations as required to document and communicate results.
• Create prototypes and conduct product testing, as necessary.
• Performs preclinical needs assessments.
• Experience with 3D modeling software (e.g. – Solidworks).
• 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.
• Contribute to and maintain compliance with company’s ISO 13485 Quality System.
• Technical team member for non-conformances, deviations, CAPAs, and root cause investigations.
• Stay current with industry trends, emerging technologies, and best practices in biomedical engineering, tissue-related fields and structural heart market.
• Maintain laboratory notebooks.
• Maintain a safe work environment.
• Other duties as reasonably assigned by the management team.

REQUIREMENTS

Education

Experience

• 10 years of medical device and design control experience.
• Extensive knowledge of the industry and market conditions, specifically collagen, tissue and other related biomaterials and contract development/manufacturing.
• Experience in tissue engineering and biomaterials is a plus.
• Experience designing and testing cardiovascular implants such as transcatheter and surgical heart valves including:
  1. Tissue selection
  2. Leaflet design
  3. Fabric integration
  4. ISO 5840 testing
     • BDC and ViVitro testing equipment
  5. Tissue Fixation
  6. Chemical Sterilization

Skills 

• Project management experience a plus.
• Working knowledge of laboratory prototyping, safety precautions and protocols for safe handling and the disposal of hazardous agents, re-agents, chemicals, and materials.
• Thorough understanding of medical device industry. Working knowledge of other related disciplines.
• Working knowledge of Design for Six Sigma, Risk Management techniques, Statistical Analysis methods, and Design of Experiments.
• Ability to travel as needed (<20%) within the US and globally.
• Exceptional organizational, communication (verbal and written) and interpersonal skills.
• Work under minimal supervision.
• Attention to detail, effective problem solving and decision-making skills.
• Knowledge of MS project software, Outlook, MS Excel, MS Word, MS PowerPoint.

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

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.