A company in the medical device industry seeks to employ an innovative and detail-oriented Project Engineer to join their team. Reporting to Senior Engineers and/or the Managing Director, you will assist in taking projects from initial concept to implementation. This role involves working with a diverse range of clients to develop cutting‑edge medical device solutions, with a focus on precision, quality, and regulatory compliance.
Key Responsibilities
Design and Development
- Use SolidWorks CAD to create and refine 3D models and technical drawings (proficiency required).
- Contribute to the design, manufacture, and assembly of implants, catheters, jigs, and tooling.
- Apply expertise in medical device R&D, with preference for Class III device experience.
Supplier and Client Collaboration
- Work with suppliers to source and deliver custom mechanical parts, stock components, tooling, software, and turnkey solutions in a timely manner.
- Collaborate with internal and external teams to ensure project objectives are met effectively.
Technical Work – Perform hands‑on tasks including
- Quality control and assurance.
- Destructive and non‑destructive testing.
- Verification and validation (V&V) activities.
- Jig design, assembly, and operation.
- 3D printing and polymer fabrication.
- Conducting in‑vitro, ex‑vivo, and in‑vivo testing.
Project Documentation
- Maintain thorough records, including R&D notes, test protocols, and reporting.
- Manage administrative tasks such as purchase orders (POs), non‑disclosure agreements (NDAs), and timesheets.
- Ensure compliance with quality management systems (QMS) and regulatory pathways.
Innovation and IP Management
- Participate in ideation sessions and design reviews.
- Conduct intellectual property (IP) reviews and contribute to the documentation of new ideas and solutions.
Requirements
- Bachelor’s degree in Biomedical Engineering, Mechanical Engineering, or a related field.
- Minimum of 3 years of experience in medical device R&D (Class III device experience preferred).
- Hands‑on experience with CAD software, especially SolidWorks.
- Familiarity with regulatory standards and pathways for medical devices.
- Strong understanding of quality control, testing methodologies, and validation techniques.
- Proficiency in 3D printing, polymer fabrication, and mechanical part design.
- Excellent organisational, communication, and time‑management skills.
- Ability to collaborate with diverse teams and manage multiple projects simultaneously.
- Strong problem‑solving and creative thinking abilities.