Operations Project Temp
Evergen
Summary
Bachelor's degree in engineering required.
Job description
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.
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.
Skills
- 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.
Physical Requirements
Ability to lift and/or carry 50 lbs.
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
- Experience with transcatheter heart valve manufacturing and/or biomaterials preferred.
- Bachelor's degree in engineering required.
- Demonstrated mastery level knowledge of design controls.
- Demonstrated mastery level knowledge of process validation.
- Demonstrated mastery level knowledge of equipment design and procurement.
- Knowledge of safety precautions and protocols for safe handling and disposal of hazardous agents, reagents, chemicals and materials.
- Knowledge of effective engineering problem solving tools.
- Knowledge of 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.
Company overview
Evergen is a leading global Contract Development and Manufacturing Organization (CDMO) specializing in regenerative medicine solutions. Founded in 1998 and headquartered in Alachua, Florida, the company operates as a strategic partner to Original Equipment Manufacturers (OEMs) across multiple medical specialties including plastic and reconstructive surgery, sports medicine and orthopedics, neuro/spine, and cardiac applications. Evergen distinguishes itself as the only regenerative medicine CDMO offering a comprehensive portfolio of both allograft and xenograft biomaterials at scale, providing customers with unbiased, needs-driven solutions. The company maintains over 280,000 square feet of cutting-edge medical device manufacturing space worldwide, featuring Class 5-7 clean rooms and Class III PMA-ready facilities. With ISO 13485 certification and FDA/USDA registration, Evergen delivers end-to-end services spanning research and development, regulatory support, manufacturing, and supply chain management. The company's patient-first approach focuses on developing customized biomaterial solutions that promote healing, accelerate recovery, and prevent complications, positioning Evergen as a trusted partner in advancing regenerative medicine technologies.