Operations Engineer

Location : 6455 City W. Pkwy, Ste 100 Eden Prairie, MN

Pay Rate: $70,000/yr DOE

Schedule: Monday-Friday, 8am-5pm

Collagen Solutions is now Evergen!

This rebrand 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/Midwest Swine, MN. Our new brand identity emphasizes our unique positioning as the only CDMO offering a comprehensive portfolio of allograft and xenograft biomaterials at scale.

About Evergen

Evergen (formally RTI Surgical) 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

Position Summary

The Operations Engineer will be based out of Eden Prairie, MN office and will support a global biomaterial med tech 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.

Essential Functions And Responsibilities

• 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 that all projects are delivered on time, within scope and within budget.
• Developing 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 escalate 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.
• Liaising with the Commercial and R&D teams as required, providing information for proposal development
• Actively supporting timely closure of CAPAs, Complaint & audit actions.
• Ensure effective engineering disciplines are followed to deliver launches of new products that can be reliably & repeatedly manufactured.
• Identify potential capacity and operation efficiency opportunities.
• Ensure all activities are performed in accordance with relevant regulations or requirements.
• Any other duties as requested by Senior Management.
  
  

Qualifications

• Bachelor’s degree in engineering or equivalent combination of education and professional experience required.
• Previous medical device industry/med tech engineering experience or equivalent and applicable course work preferred.
• Design control/process validation experience preferred.
• Demonstrated understanding of Design for Six Sigma, Risk Management techniques, Statistical Analysis methods, and Design of Experiments preferred.
• An advanced degree in applicable technical discipline is preferred.
• Experience with transcatheter heart valve manufacturing and/or biomaterials preferred.
  
  

Knowledge & Skills

• Demonstrated knowledge with:
• Design controls.
• Process validation.
• Equipment design and procurement.
• Safety precautions and protocols for safe handling and the disposal of hazardous agents, re-agents, chemicals and materials.
• Cleaning validations
• Knowledge of effective engineering problem solving tools.
• QMS change control.
• Works independently within established procedures associated with the specific job function.
• Must be able to 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.
  
  

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.