Operations Engineer 2

Job Description

Job Description

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

• Lead process improvement projects to elevate constraints and eliminate waste.
• Complete sustaining activities including OOS / OOSC forms, supplier change notifications, dose audits, and validation reviews.
• Facilitate and / or complete Corrective and Preventive Action (CAPA) activities.
• Solve problems using root cause analysis methodologies (e.g. 5 whys, fishbone analysis).
• Use statistical analysis tools and methodology to drive process improvement projects and decision making.
• Complete process validations.
• Procure and qualify equipment, tools and instruments (ETI).
• Generate technical drawings of ETI using 3D CAD software.
• Write and revise quality system documents.
• Remain current and apply the understanding of FDA-ISO 13485 and quality system requirements in carrying out duties.
• Other corporate duties as required.

REQUIREMENTS

Education

Experience

Skills

SAFETY

Physical Requirement

75%) stationary position (standing or sitting) while utilizing digital displays

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 :

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-Onsite