Product Development Engineer

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

• 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

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.

• 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

• 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

Qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or genetic information.