About the job
Position: Systems Engineer - Medical Device Industry
Location: Newark, DE
Contract Duration: Long-Term
Overview:
We are on the lookout for highly proficient Systems Engineers to become integral members of our innovative team. The successful candidate will possess between 5-8 years of experience in the medical device field, with a keen emphasis on Design Controls, traceability, and design validation. This role is pivotal in ensuring that user needs are systematically linked to design inputs, verification, and validation throughout the entire product development lifecycle.
Key Responsibilities:
- Design Controls: Spearhead the development and implementation of effective design control processes for both new and existing products, ensuring adherence to FDA regulations (21 CFR 820), ISO 13485, and pertinent industry standards.
- Traceability: Create and uphold traceability during the design and development stages, ensuring comprehensive documentation of user needs, design inputs, and verification requirements.
- User Needs to Design Validation: Collaborate across functions to connect user needs to design validation, confirming that the final product aligns with specified requirements and user expectations. This encompasses the formulation of detailed Design History Files (DHF) and validation records.
- Design Verification & Validation (V&V): Partner with various teams to guarantee that all products undergo meticulous design verification and design validation processes, demonstrating compliance with established specifications.
- Cross-Functional Collaboration: Engage closely with other engineering disciplines, including hardware, software, and quality assurance teams, to ensure cohesive integration of design controls and traceability throughout the product lifecycle.
- Documentation and Reporting: Develop and maintain comprehensive documentation for design control processes, ensuring that all outputs comply with both internal and regulatory standards. Provide regular updates to leadership and stakeholders regarding project status, risks, and timelines.
- Continuous Improvement: Identify opportunities for enhancing design control and traceability methodologies, implementing changes to improve the efficiency and effectiveness of product development.
Required Qualifications:
- Experience: 5-8 years in systems engineering within a regulated environment, ideally focused on medical devices or similarly regulated sectors.
