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Manufacturing Project Engineer
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What they do
A Manufacturing Project Engineer manages the manufacturing process from conception to completion. Supervises manufacturing teams, evaluates proposals and documentation, plans the whole manufacturing process and oversees the implementation to completion. Is the primary technical point of contact for the project.
$91,578 / year median in the U.S.
+6% projected growth
Job Description
Job Title:
Manufacturing Project Engineer Job Description We are seeking a highly motivated Project Engineer to support a large-scale capital equipment transfer project involving the relocation of a medical device production line. In this role, you will play a key part in planning, coordinating, and executing activities associated with a multi-million-dollar equipment transfer initiative, ensuring projects are completed on schedule, within scope, and in compliance with quality and regulatory requirements. You will work closely with cross-functional teams including Manufacturing Engineering, Quality, Validation, Operations, Supply Chain, and Regulatory Affairs to manage project deliverables throughout the transfer lifecycle. This position requires strong project management skills, exposure to validation activities, and the ability to drive progress using Agile and Scrum methodologies in a regulated medical device environment. Responsibilities Lead and coordinate activities associated with the transfer of manufacturing equipment and production processes between facilities. Develop and manage detailed project plans, timelines, milestones, and deliverables to ensure successful project execution. Facilitate and manage change control activities in accordance with established quality system requirements. Collaborate with cross-functional stakeholders to identify project risks, dependencies, and mitigation strategies. Support all phases of equipment implementation, including commissioning, qualification, validation, and production readiness activities. Ensure that all project activities meet applicable medical device regulations, quality standards, and internal procedures. Drive project execution using Agile and Scrum methodologies, including facilitating project meetings, providing status updates, and resolving issues. Coordinate documentation and approvals for validation protocols, reports, and associated project records. Monitor project performance, track key metrics, and communicate progress to leadership while escalating issues when necessary. Support continuous improvement initiatives and process optimization efforts throughout the transfer project. Apply risk management tools to identify, assess, and control project risks. Contribute to the development and refinement of continuous improvement methodologies within the project scope. Essential Skills Bachelor's degree in Engineering or a related technical discipline. Minimum of 3 years of project engineering or project management experience within the medical device industry. Experience leading and managing engineering or capital equipment projects in a regulated environment. Working knowledge of equipment qualification and validation activities, including commissioning, IQ/OQ/PQ, and process validation concepts. Experience managing or participating in change control processes. Strong understanding of project planning, scheduling, and execution methodologies. Excellent communication skills with the ability to present information clearly to diverse stakeholders. Effective stakeholder management skills and the ability to work collaboratively across multiple functional groups. Strong organizational abilities with a proven track record of managing multiple tasks and priorities. Demonstrated problem-solving and decision-making skills in complex technical and regulatory environments. Project management experience specific to medical device or similarly regulated industries. Ability to work effectively in cross-functional, project-based teams. Additional Skills & Qualifications Experience supporting manufacturing line transfers, equipment relocations, or site transfer projects. Familiarity with Agile and Scrum project management methodologies. Experience working under FDA or other regulated medical device quality systems. Knowledge of risk management tools used in engineering and project environments. Understanding of continuous improvement methodologies and their application to manufacturing and equipment transfer projects. Certification in Project Management, Agile, or Scrum is a plus. Exposure to medical device production processes and related quality and regulatory requirements. Work Environment The role operates within a regulated medical device environment focused on the successful transfer and implementation of production equipment and manufacturing lines. You will collaborate closely with Manufacturing Engineering, Quality, Validation, Operations, Supply Chain, and Regulatory Affairs, working in a structured, project-driven setting that emphasizes compliance with quality systems and regulatory standards. The work involves both office-based project planning and documentation activities and close interaction with production and equipment implementation areas during commissioning, qualification, and validation phases. Agile and Scrum methodologies guide project execution, promoting regular communication, iterative progress, and continuous improvement. The environment values cross-functional teamwork, clear documentation, and disciplined change control processes to ensure reliable, compliant, and efficient production line transfers. Job Type & Location This is a Contract position based out of Noblesville, IN. Pay and Benefits The pay range for this position is $48.08 - $55.29/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:- Medical, dental & vision
- Critical Illness, Accident, and Hospital
- 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available
- Life Insurance (Voluntary Life & AD&D for the employee and dependents)
- Short and long-term disability
- Health Spending Account (HSA)
- Transportation benefits
- Employee Assistance Program
- Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a fully onsite position in Noblesville,IN.