Project Engineer Medical Device Equipment Transfer
Overview
Own the transfer of capital equipment and manufacturing lines for a medical device leader, ensuring full compliance with IQ/OQ/PQ protocols. Work with a cross-functional team of process engineers and quality specialists to validate equipment performance at scale. This role demands direct coordination with vendors and regulatory stakeholders to hit aggressive project milestones. You will drive measurable outcomes in a regulated environment, reporting to the site engineering lead.
What You'll Do8
- 1Lead the transfer of capital equipment from legacy to new production lines, coordinating with vendors and internal stakeholders.
- 2Develop and execute commissioning and validation protocols, including IQ/OQ/PQ, for new and relocated equipment.
- 3Manage project timelines, budgets, and resources using MS Project or similar tools, tracking milestones against a 12-18 month roadmap.
- 4Collaborate with quality assurance to ensure all equipment meets regulatory and user requirements, documenting deviations and corrective actions.
- 5Facilitate risk assessments and design reviews for equipment modifications, applying FMEA and other reliability methods.
- 6Coordinate with maintenance and operations teams to schedule equipment installation and startup without disrupting production.
- 7Provide technical leadership during equipment troubleshooting and performance qualification, driving root cause analysis.
- 8Prepare and present project status reports to management, highlighting risks and mitigation strategies.
Requirements7
- 13+ years in project engineering or project management within the medical device industry.
- 2Bachelor's degree in engineering or a related technical discipline.
- 3Proven experience leading capital equipment transfer, line transfer, or engineering projects in a regulated environment.
- 4Strong working knowledge of equipment qualification and validation, including IQ/OQ/PQ.
- 5Hands-on experience with FDA regulations and ISO 13485 standards.
- 6Ability to manage multiple priorities and coordinate cross-functional teams in a fast-paced setting.
- 7Excellent communication and documentation skills, with attention to detail.
Salary Insight
$40 - $45k per year
Location
Required Skills
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