Senior Mechanical Engineer for Medical Devices
Overview:
This is an exciting opportunity to lead and contribute to the mechanical design and development of implantable devices and supporting instruments.
The ideal candidate will have a strong background in mechanical engineering, with experience in medical device design and commercialisation.
They will be responsible for driving design controls, ensuring regulatory-compliant documentation, and collaborating with cross-functional teams to gather insights and ensure designs meet user needs.
Key Responsibilities:
* Lead and contribute to the mechanical design and development of implantable devices and supporting instruments.
* Act as an independent technical leader while mentoring junior engineers.
* Drive design controls and ensure regulatory-compliant documentation (requirements, risk analysis, DFMEA, verification, etc.).
* Collaborate with physicians, patients, marketing, manufacturing, and global teams to gather insights and ensure designs meet user needs.
* Deliver innovative, manufacturable, and cost-effective designs, ensuring reliability and compliance with standards.
* Support product builds, validation activities, and design verification testing.
Requirements:
* Degree in Mechanical or Biomedical Engineering (minimum BSc; MSc or PhD desirable).
* 7+ years of experience with BSc, or 5+ years with MSc, in medical device design and commercialisation.
* Proven experience as a design originator/owner responsible for new product development of implantable or external devices.
* Proficiency with SolidWorks 3D CAD and industry drafting standards (ANSI Y14.5 or equivalent).
* Hands-on experience bringing products through to commercial launch.
Preferred Qualifications:
* Experience with one or more of the following: implantable pulse generators, implant leads, surgical tools, or handheld/wearable medical devices.
* Materials science/biocompatibility (metals, polymers, plastics).
* Usability assessment: animal studies, cadaver labs, preclinical or clinical evaluations.
* Strong understanding of design for manufacturability and functional testing of mechanical assemblies.
* Track record of innovation and delivering improvements or novel designs.
Benefits:
* Opportunity to work on cutting-edge medical device projects.
* Collaborative and dynamic work environment.
* Professional growth and development opportunities.