Systems Engineer - Medical Device

Fusion Life Sciences Technologies is seeking a highly skilled System Engineer to join their team. The ideal candidate will have 5-8 years of experience in the medical device industry, with a strong focus on Design Controls, traceability, and design validation.

Requirements

• Design Controls: Lead efforts to develop and implement robust design control processes for new and existing products, ensuring compliance with FDA regulations (21 CFR 820), ISO 13485, and other relevant industry standards.
• Traceability: Establish and maintain traceability throughout the design and development phases, ensuring that user needs, design inputs, and verification requirements are fully traced and documented.
• User Needs to Design Validation: Work cross-functionally to trace user needs to design validation, ensuring that final products meet both the defined requirements and user expectations.
• Design Verification & Validation (V&V): Collaborate with teams to ensure that all products undergo thorough design verification and design validation processes, providing evidence that the product meets the necessary specifications.
• Cross-Functional Collaboration: Work closely with other engineering disciplines, such as hardware, software, and quality teams, to ensure a seamless integration of design controls and traceability throughout the product lifecycle.
• Documentation and Reporting: Prepare and maintain detailed documentation for design control processes, ensuring all deliverables are compliant with internal and regulatory standards. Provide updates to leadership and stakeholders on project status, risks, and timelines.
• Continuous Improvement: Identify areas for process improvements in design control and traceability methods, and implement changes that enhance the efficiency and effectiveness of product development.