What are the responsibilities and job description for the Design Control Specialist – Medical Devices (only W2) position at Navitas Partners, LLC?
Job Title: Design Control Specialist – Medical Devices
Location: West Point, PA OR Rahway, NJ
Duration: 12 months
Job Overview:We are seeking a Design Control Specialist with hands-on experience in design verification, validation, and lifecycle management within the medical device industry. The ideal candidate will be responsible for creating and managing design control documentation, ensuring compliance with regulatory requirements, and supporting product development activities.
Key Responsibilities:- Author Design Verification & Validation (V&V) documents to support regulatory submissions and product development.
- Develop and maintain Design Traceability Matrices (DTM) and Verification & Validation Matrices (VVM).
- Manage Design History Files (DHF) and Global Design Files (GDF) to ensure compliance with industry regulations.
- Actively participate in lifecycle management of medical devices, supporting design changes and continuous improvement initiatives.
- Collaborate with cross-functional teams, including engineering, quality assurance, and regulatory affairs, to ensure design compliance.
- Support risk management activities, including Failure Mode and Effects Analysis (FMEA) and other hazard assessments.
- Assist in CAPA investigations related to design and validation processes.
- Ensure compliance with FDA, ISO 13485, and other regulatory requirements for medical devices.
- Bachelor's or Master’s degree in Engineering, Biomedical Engineering, or a related field.
- 3-5 years of experience in medical device design verification, validation, or quality engineering.
- Strong knowledge of design control regulations (FDA 21 CFR Part 820, ISO 13485, IEC 62304, ISO 14971, etc.).
- Hands-on experience with DHF, DTM, and VVM documentation.
- Experience working with product lifecycle management (PLM) tools.
- Familiarity with risk management tools such as FMEA.
- Strong technical writing skills and experience in authoring validation reports.
- Preferred Qualifications:
- Previous experience in medical device product development or quality engineering.
- Certification in CQE, Six Sigma, or PMP is a plus.
- Experience with software validation in medical devices is desirable.
