Contractor - Manufacturing Engineer

Evergen•Eden Prairie, MN

1d•Onsite

About The Position

Evergen (formerly RTI Surgical) is a leading global contract development and manufacturing organization (CDMO) in regenerative medicine. As the only regenerative medicine company offering a comprehensive portfolio of allograft and xenograft biomaterials at scale, Evergen is headquartered in Alachua, FL, with manufacturing facilities in various locations including Eden Prairie, MN. This role supports active manufacturing with a focus on continuous improvement projects and operational excellence. The position involves coordinating internal resources and vendors, ensuring projects are delivered on time, within scope, and within budget, and developing project scopes and objectives. The engineer will also measure project performance, report to management, manage client and stakeholder relationships, perform risk management, and establish vendor relationships. Additionally, the role requires creating project documentation, presenting to stakeholders, liaising with Commercial and R&D teams, supporting CAPA and audit actions, ensuring effective engineering disciplines for new product launches, identifying capacity and efficiency opportunities, and ensuring compliance with regulations. The contract is expected to last 5-6 months.

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
Demonstrated mastery level 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.
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.

Nice To Haves

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

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 support 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.