A company in the medical device industry seeks to employ a detail-oriented and innovative R&D Lab Technician to join their dynamic team. This role involves hands‑on manufacturing, assembly, and testing of small medical device components in a lab environment, with a focus on precision and quality. The successful candidate will collaborate closely with engineers and quality personnel to develop creative manufacturing processes and devices. Projects are primarily in structural heart but span various applications, including orthopaedics, pelvic floor dysfunction, anaesthetics, and surgical training.
Key Responsibilities
Manufacturing and Assembly
- Perform accurate assembly of small medical device components in clean or semi‑clean environments.
- Assist in designing and improving manufacturing processes and tools.
Testing and Quality Control
- Conduct destructive and non‑destructive testing on components and assemblies.
- Perform catheter assembly and testing (experience in this area is a plus).
- Ensure quality control compliance, adhering to Class III medical device standards (experience in Class III is a plus).
Technical Work and Development
- Design and fabricate jigs, fixtures, and prototypes using 3D printing and polymer fabrication techniques.
- Participate in in‑vitro, ex‑vivo, and in‑vivo testing to validate device performance.
Collaboration
- Work closely with internal and external team members, including engineers, quality personnel, and external vendors.
- Actively participate in design reviews, ideation sessions, and problem‑solving discussions.
Documentation and Administration
- Maintain thorough R&D notes, including test protocols, work procedures, and quality management system (QMS) documentation.
- Manage administrative tasks, such as purchase orders (POs) and timesheets, ensuring organizational compliance.
- Document and organize project results for design reviews and quality assurance.
Requirements
- Diploma or degree in a relevant technical field (e.g., Biomedical Engineering, Mechanical Engineering, or similar).
- Minimum of 2 years of experience in medical device manufacturing or R&D, with catheter assembly and Class III device experience preferred.
- Hands‑on technical experience with 3D printing, jig design, polymer fabrication, and testing techniques.
- Proficiency in manufacturing processes and quality control methodologies.
- Familiarity with regulatory standards for medical devices, including QMS documentation.
- Strong organizational and communication skills.
- Ability to work collaboratively in a team‑oriented environment.
- Creative problem‑solving and attention to detail.