Engineer III

support related to product design. The position is primarily onsite in North Lake County, IL, with occasional remote work possible depending on project requirements.

The Engineer III will be responsible for maintaining Design History Files and ensuring traceability throughout the product lifecycle. The role involves overseeing supplier changes, supporting compliance with global regulatory requirements and industry standards (including MDR, ISO 13485, ISO 14971, and ISO 10993), and collaborating with stakeholders across various functional groups and external vendors. Additional responsibilities include executing tests, managing deviations, reviewing data, and preparing technical reports.

The successful candidate will also contribute to standardizing and simplifying team processes to enhance efficiency in development and product support.

Candidates must hold a Bachelor of Science degree in engineering (bioengineering, chemical, or mechanical) and have at least three years of experience in medical device or pharmaceutical development roles. Proficiency in Design History File management, test execution, deviation reporting, and regulatory compliance is essential. Exceptional written and verbal communication skills are required, with the ability to clearly articulate development challenges and strategies to diverse stakeholders.

A graduate degree in a technical or scientific field and prior experience with consumable medical device or pharmaceutical development are desirable. The work environment includes both office and laboratory settings, with a standard Monday-Friday schedule and occasional overtime based on project needs. No travel is required for this role.

• Design History File product, on-market supplier changes, MDR requirements, ISO 13485, ISO 14971, ISO 10993

• written communication, verbal communication, medical device DHF traceability, test execution, deviation reporting, data review, report writing, FDA, EU medical device, consumable medical device development, pharmaceutical development

Support on-market medical device products by managing design changes, supplier updates, and product lifecycle documentation. This role focuses on maintaining Design History Files (DHF), ensuring traceability, supporting regulatory compliance, and providing manufacturing and product support.

• Maintain DHF documentation and product traceability
• Manage supplier and product changes for commercialized devices
• Support compliance with MDR, ISO 13485, ISO 14971, ISO 10993, and other regulatory requirements
• Execute testing, manage deviations, review data, and prepare technical reports
• Collaborate with cross-functional teams and external vendors to support product lifecycle activities and process improvements

• BS in Engineering (Bioengineering, Chemical, Mechanical, or related)
• 3+ years of medical device or pharmaceutical development experience
• Experience with DHF management, supplier changes, test execution, deviation reporting, and regulatory compliance
• Strong written and verbal communication skills

• Advanced degree in a technical/scientific field
• Experience with consumable medical devices or pharmaceutical products
• Familiarity with FDA and EU medical device regulations, data review, and technical report writing

EOE Statement: Specialist Staffing Group is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

In addition to base pay, employees may be eligible for benefits such as health insurance, health savings accounts, retirement savings plans, life and disability insurance, and paid leave where required by applicable law. Eligibility may vary based on factors such as location and hire date and is subject to change.