Associate Engineer, Engineering

Location: Portage, MI Salary: $38.00 USD Hourly - $42.00 USD Hourly Description: Our client is currently seeking a Associate Engineer, Engineering

Job Title: Associate Engineer, Engineering (Change Control & Data Collection)

Location: Portage, MI (Hybrid - 2-3 Days Onsite)

Duration: 18 Months

Job Summary

We are seeking an Associate Engineer to support change control, data collection, and regulatory compliance initiatives within a regulated manufacturing environment. This role will be responsible for retrieving, validating, analyzing, and managing product compliance data while collaborating with cross-functional teams and suppliers. The ideal candidate will have strong analytical skills, attention to detail, and experience working with engineering, quality, supply chain, and regulatory stakeholders.

Responsibilities

Lead data retrieval and collection activities from internal systems and external sources to support regulatory compliance initiatives.

Gather, compile, cleanse, and validate complex datasets to ensure accuracy, completeness, and traceability.

Partner with Engineering, Supply Chain, Quality, Regulatory Affairs, and suppliers to obtain product, component, and material compliance information.

Create, review, and manage Engineering Change Notices (ECNs) and change control documentation within Quality Management Systems.

Support regulatory compliance efforts by collecting and maintaining required documentation and evidence.

Coordinate supplier communications to obtain material declarations, certifications, and compliance documentation.

Conduct data analysis and gap assessments, identifying missing or inconsistent information and driving corrective actions.

Maintain project tracking tools, reports, and dashboards to monitor progress and compliance status.

Support audits by ensuring documentation is complete, accurate, and audit-ready.

Contribute to process improvement initiatives by standardizing data collection methods, workflows, and reporting practices.

Act as a Change Owner when required, coordinating implementation activities and ensuring timely completion.

Required Qualifications

Bachelor's Degree in Engineering or a related technical field.

Strong analytical and problem-solving skills.

Experience gathering, validating, and analyzing data from multiple sources.

Excellent communication and collaboration skills.

Strong organizational and project coordination abilities.

High attention to detail and ability to manage complex information.

Preferred Qualifications

Experience with change control or change management processes in a regulated industry.

Experience within the medical device, manufacturing, or healthcare industry.

Familiarity with Product Environmental Compliance (PEC) regulations such as REACH, RoHS, PFAS, or similar requirements.

Experience using PLM systems such as Windchill, onePLM, or equivalent platforms.

Experience working with supplier compliance documentation and supplier communications.

Knowledge of Quality Management Systems (QMS) and engineering documentation processes.

Key Competencies

Data Analysis & Validation

Change Control Management

Regulatory Compliance

Cross-Functional Collaboration

Supplier Management

Project Coordination

Process Improvement

Attention to Detail

Problem Solving

Communication Skills

Work Environment

Hybrid work schedule with 2-3 days onsite per week.

Initial training period may require increased onsite presence.

Fast-paced, collaborative environment supporting engineering and compliance initiatives.

Medical, dental, and vision insurance are available to qualified candidates who meet eligibility requirements.
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