What are the responsibilities and job description for the Sr. R&D Engineer position at Evergen?
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 project workstreams or entire projects and serves as an SME in the design and development of new implants and improvements to existing designs
- Applies and advises/mentors junior-level staff on sound engineering problem-solving techniques to resolve challenges during the product development process and analyzes data to draw conclusions using statistically sound and scientifically based methodology
- Writes, reviews, or approves protocols, reports, Standard Operating Procedures (SOPs), and other technical documents in accordance with Good Documentation Practices with high attention to detail. May serve as an owner of documents within the QMS. Knowledgably applies principles of ISO 13485 and ISO 14971
- Designs, develops, and validates test methods to meet design requirements with the highest level of execution
- Effectively leads by influence on cross-functional teams with quality, regulatory, engineering, and production throughout the product development process and to meet project objectives
- May independently lead discussions with internal or external customers to obtain design requirements and feedback on prototype designs with a high level of customer service
- Maintains project timelines by providing appropriate inputs, target times, and resource needs
- Apply deep knowledge and experiences from across multiple clinical segments to develop innovative solutions to satisfy customer needs
- Evaluate product design for manufacturability and suggest design process adjustments and quality improvements
- Participates in the selection, development, and testing of tools, fixtures, machinery, and equipment used in manufacturing
- May mentor or lead other team members
- Other duties as assigned
REQUIREMENTS:
Education
- Bachelor of Science Degree in Biomedical Engineering or another relevant engineering discipline
Experience
- At least 6 years’ engineering experience designing or modifying medical devices or implants
Skills
- Excellent verbal and written communication
- Microsoft Office Suite
- Project Management
- Computer Aided Drafting (CAD) software
- Statistical analysis software
- Design Control and Design History Files
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.)
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.
Salary : $85,000 - $105,000