Product Development Engineer

Job Title: Product Development Engineer (Medical Device)Location: North Chicago, ILHire Type: 12 month contractTarget Pay Rate: $50-$56/hrBenefits: PTO, paid holidays, BCBS medical plans, dental/vision plans, 401(k), ESOPMust-Have Skills:Bachelor's degree in Mechanical, Biomedical, Bioengineering, Chemical Engineering, or related engineering discipline3+ years of medical device, combination product, or pharmaceutical product development experienceExperience with Design History Files (DHF) and design controlsExperience supporting commercialized/on-market productsStrong technical writing, data analysis, and problem-solving skillsExperience working with cross-functional teams in a regulated environmentJob 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 productsEvaluate supplier, material, and manufacturing changes to determine product impactMaintain Design History File (DHF) documentation and ensure design traceabilityDevelop and execute verification testing protocols for product and process changesAnalyze engineering and test data, investigate deviations, and prepare technical reportsSupport risk management activities and regulatory compliance initiativesCollaborate with Engineering, Quality, Regulatory, Manufacturing, Supply Chain, and external suppliers to implement product changesDrive continuous improvement initiatives related to engineering processes and documentationProvide technical support for manufacturing and ongoing product performanceQualifications:Bachelor's degree in Mechanical Engineering, Biomedical Engineering, Bioengineering, Chemical Engineering, or a related technical discipline3+ years of experience developing or supporting medical devices, combination products, or other regulated productsExperience with Design History Files (DHF), design controls, and engineering documentationKnowledge of FDA regulations and medical device quality systems preferredFamiliarity with ISO 13485, ISO 14971, ISO 10993, MDR, or similar regulatory standards is a plusExperience with supplier change management is preferredStrong communication, analytical, and problem-solving skillsAbility to work independently and collaborate effectively with cross-functional teamsQualified 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.