Design Engineer

Design Engineer

Location: Wilmington, Delaware (Hybrid)

About Our Client:

Our Hiring Company, a best-in-class Medical Device Manufacturer has an opening for a new team member at their facility. Holding itself to the highest standards of integrity, quality and excellence, this company has contributed to the healthcare industry for over 90 years and has been rated as Forbes top 14 most innovative companies in the world. With a strong vision for making medical treatments easier on its patients, this company gears its technological innovations from its top-talented engineers towards making a significant contribution to our society.

Key Responsibilities:

• Leading structured and interdisciplinary development of product systems from concept to production.
• Collaborating with cross-functional teams to ensure product development aligns with customer needs and regulatory requirements.
• Maintaining and following the company's quality system requirements, including change control, validation, documentation, and design controls.
• Providing cross-functional leadership as the product integrity group representative in NPD projects.
• Ensuring a consistent approach in product development to deliver high-quality, customer-focused products.
• Coordinating with internal teams and external partners to drive results and ensure quality.
• Troubleshooting system-level issues through hands-on problem-solving and cross-functional collaboration.
• Leading human factors and usability activities to ensure clinical acceptability of new products.
• Participating in design, development, and testing activities to uphold product design intent.
• Defining and writing test plans/protocols, performing testing, analyzing results, and documenting findings in technical reports for regulatory submissions.
• Coordinating design verification activities and supporting the development of test methodologies.
• Managing partnerships with external organizations for design, prototyping, testing, and validation.
• Ensuring cost viability of new products throughout the development cycle.
• Preparing and leading portions of design reviews with cross-functional teams.
• Contributing to project team meetings with innovative ideas and process improvements.
• Planning and scheduling technical objectives, coordinating resources, and ensuring proper documentation.

Qualifications:

• Bachelor’s degree in Mechanical Engineering or Biomedical Engineering.
• 3 years of experience with product development and design controls.
• Experience in an FDA-regulated industry (medical device or pharmaceutical).
• Hands-on experience in the product development life cycle and understanding of test method development.
• Ability to provide technical oversight, lead design input documentation, and support product specification completion.
• Strong analytical and problem-solving skills for solving moderately complex system-level issues.
• Strong communication skills, including the ability to explain complex engineering problems to non-engineers, present to executive management, and develop detailed technical reports for regulatory submissions.
• Strong coordination skills to align cross-functional and external teams to deliver high-quality products.
• Ability to implement systems engineering strategies and evaluate alternative product designs, processes, and test methods.
• Experience in creating documentation for Design History Files (DHF) and regulatory filings.
• Ability to define, write, and execute test protocols, including design verification.
• Experience in technical drawing review and approval.
• Ability to work with engineering drawings, specifications, and marketing requirements.
• Familiarity with mechanical, electronic, and chemical equipment used in laboratory testing.
• Willingness to travel for clinical observations, trade shows, training, and supplier visits (vendor credentialing required).
• Experience with SolidWorks is preferred.

Interested Candidates please apply on our website at https://jobs.jblresources.com.

For more information about our services and great opportunities at JBL Resources, please visit our website: https://www.jblresources.com.

JBL Resources is proud to have earned the reputation of being a premier provider of top talent professionals in the fields of engineering, human resources, logistics, operations, and supply chain management. As specialists in both permanent placement and contract services, our mission is to help companies and individuals become all they were created to be.

**JBL is an Equal Opportunity Employer and E-Verify Company