Operations Project Temp

Location: On site: 1425 Innovation Pl., West Lafayette, IN 47906 20-40 hours per week $17-20 per hour Length of Contract: 5-6 weeks 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 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. Travel -10% Skills: 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. 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…

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