Job
Description
Design engineer Risk Management V&V Job Overview: We are seeking highly skilled and experienced System Engineers to join our 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. This individual will play a critical role in ensuring that user needs are clearly traced to design inputs, verification, and validation throughout the product development lifecycle. Key Responsibilities: 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. This includes the development of comprehensive Design History Files (DHF) and validation documentation. 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. Required Qualifications: Experience: 5-8 years of experience in system engineering within a regulated environment, preferably in medical devices or other highly regulated industries. Design Controls: Strong experience in implementing and managing design controls processes, including traceability, user needs, and design verification/validation. Traceability: Proven ability to ensure full traceability from user needs to design validation and manage product documentation accordingly. Regulatory Knowledge: In-depth knowledge of FDA regulations (21 CFR 820), ISO 13485, and other applicable standards for medical devices. Collaboration: Strong communication and interpersonal skills, with experience working effectively in cross-functional teams. Strong verbal and written communication in English. Preferred Qualifications: Risk Management: Experience with risk management processes, including risk analysis, risk assessment, and mitigation strategies (e.g., ISO 14971). V&V Experience: Familiarity with verification and validation techniques and methodologies for ensuring that product designs meet both functional and regulatory requirements. Software and Tools: Experience with requirements management tools, traceability software, and common V&V tools. Personal Attributes: Strong analytical and problem-solving skills Ability to manage and prioritize multiple tasks in a fast-paced environment Detail-oriented with a commitment to accuracy Proactive and able to work independently or as part of a team
