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Product Development Engineer

Sterling Engineering, Inc.

North Chicago, IL

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JOB DETAILS
SALARY
$50–$56 Per Hour
SKILLS
Analysis Skills, Bioengineering, Biomedical Engineering, Biomedicine, Change Management, Chemical Engineering, Communication Skills, Continuous Improvement, Cross-Functional, Data Analysis, Document Management, Documentation, Drug Development, FDA Requirements, File Maintenance, Functional Analysis, Health Plan, Healthcare Quality, ISO (International Organization for Standardization), Maintain Compliance, Manufacturing, Manufacturing Requirements, Materials Testing, Mechanical Engineering, Medical Equipment, Problem Solving Skills, Process Improvement, Product Development, Product Engineering, Product Lifecycle Management, Product Support, Product Testing, Regulations, Regulatory Compliance, Regulatory Requirements, Reporting Skills, Risk Management, Supply Chain, Technical Support, Technical Writing, Test Data, Testing, Traceability, Vendor/Supplier Evaluation, Writing Skills
LOCATION
North Chicago, IL
POSTED
1 day ago

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
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.

About the Company

S

Sterling Engineering, Inc.

Sterling Engineering has been a trusted partner for engineering, project management, and staffing solutions for over five decades. We provide exceptional engineering/technical recruitment and engineering project services to clients nationwide:

 

  • Engineering & Technical Recruitment - With our focus on engineering, technical, and IT, Sterling has the in-depth knowledge, industry expertise, and robust employee pipeline it takes to rapidly find talent for even the most difficult to fill positions. Sterling’s extensive recruitment methodology allows us to engage the most talented employees in the marketplace. We offer exciting work and career-building opportunities for our candidates, along with expert support at every step of the process.

 

  • Engineering Project Services – Our experienced, multi-disciplined team of project managers, engineers, and designers, led by licensed Professional Engineers (PE), provide project management, engineering, design, and Commissioning, Qualification, and Validation (CQV) to manufacturing, OEM, and R&D customers. We work on complex, highly technical projects across a number of industry sectors, and our ability to scale and seamlessly integrate at multiple levels of your organization is what differentiates us.

 

Sterling offers a unique combination of engineering solutions and Best of Staffing level service to help our clients and talent achieve their goals.

COMPANY SIZE
500 to 999 employees
INDUSTRY
Staffing/Employment Agencies
FOUNDED
1969
WEBSITE
http://www.sterling-engineering.com

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