Job Description

Job Title: Design Engineer (Medical Device Industry)
Location: United States (Location details specific to the role)

Duration: 12 months (Contract on W2)

We are seeking a highly skilled Design Engineer to join our team in the medical device industry . In this role, you will be responsible for designing and developing innovative medical devices, ensuring that they meet both functional requirements and regulatory standards. You will work collaboratively with cross-functional teams, including R&D, manufacturing, and quality assurance, to bring new products from concept to commercialization. This is a fantastic opportunity to be part of a dynamic and impactful industry that focuses on improving patient care and outcomes.

• Design and develop medical devices, from concept through to detailed design, ensuring compliance with regulatory and quality standards.
• Collaborate with cross-functional teams (R&D, manufacturing, regulatory, and quality assurance) to translate customer needs and technical requirements into design solutions.
• Develop and document detailed design specifications, including CAD models, drawings, and design verification plans.
• Perform detailed analysis and simulations to ensure product designs meet performance, safety, and reliability criteria (e.g., mechanical, thermal, and electrical analyses).
• Create and maintain accurate documentation of the design process, including risk assessments, design history files (DHF), and design transfer materials.
• Participate in design reviews, ensuring that designs meet internal and external customer requirements, quality standards, and compliance guidelines.
• Lead prototype development, testing, and validation, iterating designs based on test results and customer feedback.
• Manage design changes and updates, ensuring that all revisions are tracked and communicated effectively across teams.
• Ensure that designs comply with FDA regulations , ISO 13485 , and other relevant medical device industry standards.
• Contribute to the design transfer process by collaborating with manufacturing engineers to ensure designs can be efficiently produced at scale.
• Assist in the creation and review of technical documentation for regulatory submissions (e.g., 510(k), PMA) as required.
• Stay updated on industry trends, emerging technologies, and best practices related to medical device design.

• Bachelor's degree in Biomedical Engineering , Mechanical Engineering , Industrial Engineering , or a related field.
• 2-5 years of experience in medical device design , preferably with experience in designing Class II or Class III medical devices .
• Strong proficiency in 3D CAD software (e.g., SolidWorks , Pro/Engineer , AutoCAD ).
• Knowledge of FDA regulations , ISO 13485 , and other applicable regulatory standards for medical devices.
• Strong understanding of material selection, manufacturing processes, and design for manufacturability.
• Experience with design verification and validation testing , including the development of test protocols and reports.
• Excellent problem-solving, analytical, and troubleshooting skills.
• Strong communication skills, both verbal and written, for documentation, presentations, and collaboration with cross-functional teams.
• Ability to manage multiple projects simultaneously and work effectively under deadlines.

• Experience in designing Class II or Class III medical devices .
• Certified SolidWorks Professional (CSWP) or other relevant CAD certifications.
• Experience with design control processes and maintaining Design History Files (DHF) .
• Familiarity with Failure Mode Effects Analysis (FMEA) and risk management processes.
• Knowledge of biocompatibility , sterilization processes , and packaging for medical devices.
• Experience with regulatory submissions (e.g., 510(k), PMA) and preparing technical documentation for FDA submissions.

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