Job Title: Product Development Engineer (Medical Device)
Location: North Chicago, IL
Hire Type: 12 month contract
Target Pay Rate: $50-$56/hr
Benefits: PTO, paid holidays, BCBS medical plans, dental/vision plans, 401(k), ESOP

Must-Have Skills:

• Bachelor's degree in Mechanical, Biomedical, Bioengineering, Chemical Engineering, or related engineering discipline
• 3+ years of medical device, combination product, or pharmaceutical product development experience
• Experience with Design History Files (DHF) and design controls
• Experience supporting commercialized/on-market products
• Strong technical writing, data analysis, and problem-solving skills
• Experience working with cross-functional teams in a regulated environment

Job Summary:

The Product Development Engineer supports commercially released medical devices and combination products through product lifecycle management, engineering change implementation, supplier change assessments, and manufacturing support. This role partners with cross-functional teams to evaluate, document, test, and implement product changes while ensuring compliance with quality and regulatory requirements.

Job Duties:

• Support product lifecycle management activities for commercialized medical devices and combination products
• Evaluate supplier, material, and manufacturing changes to determine product impact
• Maintain Design History File (DHF) documentation and ensure design traceability
• Develop and execute verification testing protocols for product and process changes
• Analyze engineering and test data, investigate deviations, and prepare technical reports
• Support risk management activities and regulatory compliance initiatives
• Collaborate with Engineering, Quality, Regulatory, Manufacturing, Supply Chain, and external suppliers to implement product changes
• Drive continuous improvement initiatives related to engineering processes and documentation
• Provide technical support for manufacturing and ongoing product performance

Qualifications:

• Bachelor's degree in Mechanical Engineering, Biomedical Engineering, Bioengineering, Chemical Engineering, or a related technical discipline
• 3+ years of experience developing or supporting medical devices, combination products, or other regulated products
• Experience with Design History Files (DHF), design controls, and engineering documentation
• Knowledge of FDA regulations and medical device quality systems preferred
• Familiarity with ISO 13485, ISO 14971, ISO 10993, MDR, or similar regulatory standards is a plus
• Experience with supplier change management is preferred
• Strong communication, analytical, and problem-solving skills
• Ability to work independently and collaborate effectively with cross-functional teams