Engineering Manager

Evergen • Eden Prairie, MN

3d • Onsite

About The Position

Evergen (formerly 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 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. This role is based in Eden Prairie, MN, and operates within an office environment with an assigned workstation during standard office hours of 8 am-5 pm.

Requirements

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

Nice To Haves

• Experience with transcatheter heart valve manufacturing and/or biomaterials preferred.

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.

Benefits

• The job description does not explicitly list benefits, but mentions the company's commitment to diversity, equity, and inclusion, and fostering an inclusive workplace.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager