Associate Engineer - Change Control & Data CollectionLocation: Hybrid - Kalamazoo, MI (2-4 days onsite after training)
Position OverviewWe are seeking an Associate Engineer to join a growing Project Management Office (PMO) supporting Product Environmental Compliance (PEC) initiatives across global medical device manufacturing operations. This is an excellent opportunity for an early-career engineer who enjoys working with data, collaborating across teams, and supporting regulatory compliance efforts.
In this role, you will support multiple engineering projects by collecting, validating, and managing product compliance data while coordinating engineering change activities. You will partner with Engineering, Supply Chain, Quality, Regulatory Affairs, and suppliers to ensure product information is accurate, complete, and ready for regulatory submission.
This position is ideal for someone who is highly organized, analytical, detail-oriented, and eager to grow within a fast-paced engineering environment.
ResponsibilitiesChange Control & Compliance Support- Coordinate Engineering Change Notices (ECNs) within the Quality Management System (QMS), ensuring documentation is complete, accurate, and audit-ready.
- Support change control activities related to Product Environmental Compliance (PEC) requirements.
- Assist with implementation planning and change execution to meet regulatory timelines.
Data Collection & Analysis- Gather, organize, validate, and maintain engineering and compliance data from internal systems (PLM, ERP, QMS) and external supplier sources.
- Analyze complex datasets to identify missing, inaccurate, or inconsistent information.
- Translate regulatory requirements into specific data and documentation needs.
- Build reports, dashboards, and tracking tools using Excel and Power BI to monitor project progress and compliance status.
- Review source files and engineering documentation to ensure data integrity and traceability.
Cross-Functional Collaboration- Partner with Engineering, Regulatory Affairs, Supply Chain, Quality, and external suppliers to obtain product and material compliance documentation.
- Track supplier responses, certifications, and material declarations while following up to ensure timely completion.
- Support multiple projects simultaneously while communicating status, risks, and priorities to stakeholders.
Process Improvement- Identify opportunities to improve data collection processes, reporting methods, and documentation standards.
- Help standardize templates and workflows to improve efficiency and consistency across projects.
- Proactively escalate issues and recommend solutions when data gaps or project risks arise.
QualificationsRequired- Bachelor's degree in Engineering or a related technical discipline.
- Approximately 1-3 years of professional experience supporting engineering, change control, project coordination, or data management. Strong internship experience will also be considered.
- Experience gathering, analyzing, and validating data from multiple sources.
- Strong organizational skills with the ability to manage multiple priorities simultaneously.
- Excellent analytical, problem-solving, and communication skills.
- Proficiency with Microsoft Excel; experience with Power BI is a plus.
Preferred- Experience working in a regulated industry such as medical devices, pharmaceuticals, or manufacturing.
- Exposure to engineering change control or change management processes.
- Familiarity with Product Lifecycle Management (PLM) systems such as Windchill or onePLM.
- Knowledge of Product Environmental Compliance (PEC) regulations, including REACH, RoHS, PFAS, or similar requirements.
- Experience working with suppliers to collect compliance documentation or technical data.
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