R&D Specialist at RTI Surgical Inc – West Lafayette, Indiana

Location: West Lafayette, IN

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

• Create product part numbers and bills of material, manufacturing instructions, work orders, and other quality system documents.
• Create and monitor change requests.
• Provide support for developing product labels based on engineering and regulatory input.
• Provide support for creating and modifying Instructions for Use, Patient Instructions, and Implant Cards.
• Take meeting minutes for design and phase review meetings.
• Ensure timely completion of tasks.
• Remain current and apply the understanding of FDA-ISO 13485 and Quality System requirements in carrying out duties.
• Learn how to perform tasks related to area of work and gain understanding in systems.
• Consult with senior team members and supervisor
• Work with members of the Engineering Logistics team to ensure project priorities are being achieved.
• Propose improvement opportunities
• Communicate with document control to address any issues with documentation.
• Communicate project updates to the affected areas.
• Conduct other corporate duties when required.

REQUIREMENTS:

Education

Experience

• Experience in basic office equipment, i.e., fax, copier, computer, printers, phone systems, etc.
• Able to present a professional and personable demeanor in phone and face-to-face interactions.
• Able to work both independently and as a member of a team depending on the needs of the project.

Skills

• Excellent written, verbal, and organizational skills.
• Attention to detail.
• Experience in Microsoft and Adobe software.
• Able to handle multiple and changing priorities along with fluctuations in workload.

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
• Remote positions only: Home office environment with minimum distractions

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.

#LI-Hybrid