Biomaterials Developer Jobs (NOW HIRING)

Location: On site: 6455 City West Pkwy Suite 100, Eden Prairie, MN 55344

Bonus: Eligible for $15,000 annual target

Office hours: 8am-5pm

Why Join Us?

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:

• Oversees the overall performance of the engineering responsibilities and employees within; including project completion, quality/regulatory compliance, driving lean initiatives and achieving set metrics.
• Participates in lean daily management and supports relevant metrics and drivers for assigned areas
• Drives plant performance and predictability by establishing, maintaining, and cultivating relevant KPIs, goals, and expectations
• Oversees engineering activities required for the development, verification, and validation (process & development) of market-released product
• Coordinates with site leadership on new product development to ensure operational readiness for the implementation of new processes into production
• Coordinates with planning, production, quality and other support functions to ensure production goals can be met on-time
• Mentors and gives timely performance management feedback to direct staff and provides strong oversight for employees reporting under direct staff; provides clear, consistent, and measurable direction regarding timelines and deliverables
• Understands and makes recommendations for materials, processes, procedures, and equipment within assigned areas to drive cost efficiency and improvement
• Develops engineering process controls to achieve consistent and predictable outcomes
• Ensures a continuous improvement safety culture that drives the assigned areas to achieve the goal of zero incidents
• Supports problem-solving activities and effective corrective actions in assigned areas

Qualifications:

• 4+ years of medical device industry/med tech engineering experience required.
• Design control/process validation experience required.
• Thorough understanding of Design for Six Sigma, Risk Management techniques, Statistical Analysis methods, and Design of Experiments required
• Experience with transcatheter heart valve manufacturing and/or biomaterials preferred.

Education:

• Bachelor’s degree in engineering required.

Experience

• 5+ years of experience in a regulated engineering production environment
• 3+ years of leadership experience in a regulated engineering production environment

Travel -10%

Skills:

• Microsoft Office Suite, advanced
• Excellent verbal and written communication
• Business Intelligence software
• Project Management
• Current Good Manufacturing Practices (CGMP)
• Lean Manufacturing Practices
• Computer Aided Drafting software
• Technical writing
• Statistical methods and analysis

Physical Requirements:

• Ability to lift and/or carry 50 lbs.

Onsite: Office environment with assigned workstation

COMPANY SUMMARY:

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 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 headquartered in Alachua, FL, and has manufacturing facilities in West Lafayette, IN., Eden Prairie and Glencoe, MN., and Neunkirchen, Germany.

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 Evergen in 2020 and has supported the transformation of the company to its next level of potential.