PURPOSE OF JOB
A Senior R&D Engineer is required to support Needletech Product’s world-class Medical Device Design Services team through a phase of rapid growth due to new business activities. This position will report to the Design Services Manager and will be responsible for supporting all aspects of the Product Development Process. The role will require a hands-on approach involving design, prototyping, and development of novel interventional guidewire and catheter devices for our clients in the vascular access and therapies sector. The successful candidate will apply their diverse engineering and problem-solving skills to develop novel solutions which exceed customer expectations while also providing excellent internal and client-facing communication skills. Given the nature of minimally invasive intravascular products, the ideal candidate will have a good eye for detail and possess manual dexterity skills to manipulate small components during the fabrication of prototype medical devices. The range of projects that the role will support will be diverse and present an opportunity to acquire significant skills in the development of novel interventional medical devices.
RESPONSIBILITIES
- Design and develop innovative technology solutions to meet customer needs. This will include developing novel processing technologies and prototyping of medical device designs.
- Build and enhance Needletech Product’s intellectual property portfolio in device design and process technology know-how.
- Manage and track “time and material” efforts for each assigned project, keep organized records, and provide technical reports as needed.
- Document novel assembly processes and device designs using 3D/2D design modeling, written specifications, design verification testing, laboratory notebook, etc.
- Ensure strict adherence to relevant Design Control, ISO Good Manufacturing Practice, and safety procedures.
REQUIREMENTS
EDUCATION:
- Bachelor’s Degree in Biomedical/Mechanical/Polymer Engineering (required)
EXPERIENCE:
- 5 - 10 years of relevant experience within the medical device manufacturing industry (required)
- Good working knowledge of medical device manufacturing processes, such as machining, wire and tube grinding, spring coiling, molding and extrusions, small component welding, catheter assembly, etc.
PREFERRED QUALIFICATIONS:
- Experience with surgical products, catheters, or microcatheters highly preferred.
- Knowledge of contract engineering and design services.
- Understanding of Design Control processes.
- Previous experience managing and tracking “time and material” in projects.
- Demonstrated experience in the design of medical devices and/or manufacturing tooling using Solidworks or equivalent.
POSITION SKILLS:
- Proficient in 3D Modelling software (e.g., Solidworks), along with MS Office software (MS Excel, Word, PowerPoint).
- Must be able to communicate effectively, keep detailed documentation, and write clear, concise technical reports.