Operations Project Temp

Evergen•West Lafayette, IN

10h•$17 - $20•Onsite

About The Position

The Operations Project Temp supports active manufacturing, with a focus on continuous improvement projects and operational excellence. The role coordinates internal resources and vendors to deliver projects on time, within scope, and within budget. Responsibilities include defining project scopes and objectives, developing project plans, tracking performance, managing risks and stakeholder relationships, maintaining project documentation, and reporting or escalating issues to management. The position works with Commercial and R&D teams as needed to support proposal development, and supports timely closure of CAPAs, complaints, and audit actions. It applies effective engineering disciplines to launch products that can be reliably and repeatedly manufactured, identifies capacity and operational-efficiency opportunities, and ensures activities meet relevant regulations and requirements. The role is onsite in an office environment with an assigned workstation, at 1425 Innovation Pl., West Lafayette, Indiana. The contract is 5–6 weeks, with a schedule of 20–40 hours per week and travel of 10%.

Requirements

At least 4 years of medical device industry or med-tech engineering experience.
Experience with design controls and process validation.
Thorough understanding of Design for Six Sigma, risk management techniques, statistical analysis methods, and Design of Experiments.
Bachelor’s degree in engineering.
Mastery-level knowledge of design controls, process validation, equipment design and procurement, safety precautions and protocols for safely handling and disposing of hazardous agents, reagents, chemicals, and materials, effective engineering problem-solving tools, and QMS change control.
Ability to work independently within established procedures associated with the job function.
Ability to adjust to shifting and sometimes unexpected priorities and new responsibilities.
Exceptional organizational, verbal and written communication, and interpersonal skills.
Ability to lift and/or carry 50 lbs.

Nice To Haves

Experience with transcatheter heart valve manufacturing and/or biomaterials.

Responsibilities

Support active manufacturing, focusing on continuous improvement projects and operational excellence.
Coordinate internal resources and third parties or vendors to ensure project execution.
Ensure projects are delivered on time, within scope, and within budget.
Develop project scopes and objectives with relevant stakeholders and assess technical feasibility.
Develop detailed project plans and track progress.
Measure project performance using appropriate systems, tools, and techniques.
Report and escalate issues to management as needed.
Manage relationships with clients and stakeholders.
Perform risk management to minimize project risks.
Establish and maintain relationships with third parties and vendors.
Create and maintain comprehensive project documentation.
Present to the business and key stakeholders as appropriate.
Liaise with Commercial and R&D teams as required, providing information for proposal development.
Support timely closure of CAPAs, complaints, and audit actions.
Ensure effective engineering disciplines are followed to deliver launches of new products that can be reliably and repeatedly manufactured.
Identify potential capacity and operational-efficiency opportunities.
Ensure activities are performed in accordance with relevant regulations or requirements.
Perform other duties as requested by Senior Management.