Overview
Product Development Engineer (Medical Device/Pharmaceutical) Jobs in North Chicago, IL at Sterling Engineering
Title: Product Development Engineer (Medical Device/Pharmaceutical)
Company: Sterling Engineering
Location: North Chicago, IL
Job Title: Product Development Engineer (Medical Device/Pharmaceutical)
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
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.
