Operations Engineer

About Evergen

Evergen (formerly RTI Surgical) is a global industry‑leading contract development and manufacturing organization (CDMO) in regenerative medicine. It is the only CDMO offering a comprehensive portfolio of allograft and xenograft biomaterials dquartered in Alachua, FL, it has manufacturing facilities in West Lafayette, IN,
Eden Prairie and Glencoe
, MN, Neunkirchen, DE, Glasgow, UK, and Marton, NZ.

The Operations Engineer will be based in the Eden Prairie, MN office and will support a global biomaterial medical‑technology organization. The role is a key member of the engineering team reporting to the Sr. Operations Manager. The Operations Engineer is a primary point of contact for manufacturing projects from new product introductions to continuous improvement projects. The Operations Engineer integrates with other departments on multiple manufacturing projects, ensuring that they run to budget and within timelines.

This role supports Production, EHS, Operational Excellence, and quality functions to ensure coordinated manufacturing of products.

• Supports active manufacturing with a focus on continuous improvement projects and operational excellence.
• Coordinate internal resources and third parties/vendors to ensure execution of projects.
• Ensure all projects are delivered on time, within scope and within budget.
• Develop project scopes and objectives, involving all relevant stakeholders and ensuring technical feasibility.
• Develop detailed project plans to track progress.
• Measure project performance using appropriate systems, tools and techniques.
• Report and escalated to management as needed.
• Manage the relationship with the client and all stakeholders.
• Perform risk management to minimize project risks.
• Establish and maintain relationships with third parties/vendors.
• Create and maintain comprehensive project documentation.
• Present to the business and key stakeholders as appropriate.
• Liaise with Commercial and R&D teams as required, providing information for proposal development.
• Actively support timely closure of CAPAs, Complaint & audit actions.
• Ensure effective engineering disciplines are followed to deliver launches of new products that are reliable and repeatably manufactured.
• Identify capacity and operational efficiency opportunities.
• Ensure all activities are performed in accordance with relevant regulations or requirements.
• Any other duties as requested by Senior Management.

• Bachelor’s degree in engineering required.
• Previous experience in medical device industry and/or medical tech engineering experience preferred.
• Design control/process validation experience preferred.
• Manufacturing Transfer/Line Transfer experience preferred.
• Understanding of Design for Six Sigma, Risk Management techniques, Statistical Analysis methods, and Design of Experiments preferred.
• Advanced degree in technical discipline preferred.
• Experience with transcatheter heart valve manufacturing and/or biomaterials preferred.

• Demonstrated knowledge of:
  • Design controls
  • Process validation
  • Equipment design and procurement
  • Safety precautions and protocols for safe handling and the disposal of hazardous agents, reagents, chemicals and materials
  • Cleaning validations
  • Effective engineering problem solving tools
  • QMS change control
• Works independently within established procedures associated with the specific job function.
• Can adjust to shifting and sometimes unexpected priorities and new responsibilities.
• Exceptional organizational, communication (verbal and written) and interpersonal skills.
• Ability to lift and/or carry 50 lbs.

• 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.

Mid‑Senior level

Full‑time

Engineering and Information Technology, Medical Equipment Manufacturing