Product Development Engineer

Net2Source Inc. is an award-winning total workforce solutions company recognized for their accelerated growth and global operations. They are seeking a Product Development Engineer with a solid background in medical device design controls and product development to refine documentation and ensure regulatory alignment for new and existing products.

Responsibilities:

• Define the design approach, ensuring alignment with product objectives, user needs, clinical workflows, and system performance
• Translate user needs and system requirements into practical design solutions
• Lead design discussions and technical reviews, evaluating alternatives and trade-offs
• Ensure design decisions address usability, risk mitigation, technical feasibility, and long-term product sustainability
• Implement and review product verification and validation (V&V) testing, including developing protocols, test methods, and performance specifications
• Perform manual and automated testing and document results accurately
• Collaborate with QA, Service, Compliance, and Regulatory teams to meet documentation requirements and ensure cross-functional alignment
• Create, review, and maintain risk management files, including cybersecurity risks
• Ensure all product requirements are documented, traceable to verifiable tests, and kept up-to-date
• Ensure compliance with FDA, ISO, and internal design controls
• Maintain the Design History File (DHF) to be complete, accurate, and regulatory-compliant, addressing gaps proactively

Requirements:

• 5+ years of experience
• Strong Experience with Software as a Medical Device (SaMD)
• Strong experience in design controls in a multi-disciplinary organization
• Experience drafting and maintaining DHF (design history file) content, including user needs, design inputs, design outputs, traceability matrices, and risk documentation
• Able to support risk analysis (e.g. uFMEA, etc.) and contribute to usability planning and design mitigations
• Familiarity with ISO 14971 is required, and IEC 62366 preferred
• Ability to define testable requirements, support V&V protocol development, and ensure traceability in collaboration with the Product Development team
• Strong collaboration skills across R&D, QA, clinical, and regulatory functions; able to clearly translate technical information across stakeholders
• Must have experience in a regulatory environment with strict compliance
• Strong analytical skills and accurate judgment-making skills
• Ability to deal effectively with internal and external collaborators
• Excellent communications skills; written and verbal
• Experience with Codebeamer, Jira, or similar
• Bachelor's degree in engineering or science related field; biomedical engineering preferred