Engineer III

Real; Orland Park (IL); Hybrid; USD 95,000 - 130,000; Full time

Job summary

Specialist Staffing Group is seeking an Engineer III for medical device/product lifecycle support in North Lake County, IL, primarily onsite with occasional remote work depending on project requirements. You will maintain Design History Files (DHF), oversee supplier changes, and support regulatory compliance across MDR and ISO standards.

The role requires a BS in Engineering (bioengineering, chemical or mechanical) with 3+ years in medical device or pharmaceutical development, strong written and

Qualifications

• Experience with DHF management and regulatory compliance.
• Familiarity with MDR, ISO 13485, ISO 14971, ISO 10993 requirements.
• Strong written and verbal communication skills.

Responsibilities

• Maintain DHF documentation and product traceability.
• Manage supplier and product changes for commercialized devices.
• Support MDR/ISO regulatory requirements and related standards.
• Execute testing, manage deviations, review data, and prepare technical reports.
• Collaborate with cross-functional teams and external vendors on lifecycle activities.

Skills

DHF management

Supplier changes

MDR requirements

ISO 13485

ISO 14971

ISO 10993

Education

Bachelor's degree in Engineering (Bioengineering, Chemical, Mechanical, or related)

Advanced degree in technical/scientific field

Job description

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.

Must-Have Skills: Design History File product, on-market supplier changes, MDR requirements, ISO 13485, ISO 14971, ISO 10993

Nice-to-Have Skills: 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

Engineer III - Medical Device/Product Lifecycle Support (North Lake County, IL)

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.

Key Responsibilities

• 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

Required Qualifications

• 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

Preferred Qualifications

• 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.