Senior Mechanical Engineer
1 week ago
Direct message the job poster from Neo-Bionica Technical Leader | Medical Device Technologies | Neurotechnologies | Mechanical/Biomedical Engineer | ex-Synchron Organisation Context Neo-Bionica is a pioneering product development and contract manufacturing company specialising in neurotechnology, headquartered in Australia.
Our mission is to partner in developing cutting-edge medical devices that improve the quality of life for individuals with neurological conditions.
We are committed to innovation, excellence, and transforming healthcare through advanced technology.
Position Summary: This role plays a key role in designing, developing, and transferring Class III and AIMD neurotechnology medical devices.
This hands-on role requires expertise in mechanical engineering, systems integration, DFM, risk management, and regulatory compliance.
The candidate will lead projects from concept to manufacturing, mentor junior engineers, and collaborate cross-functionally to optimize development processes.
Key Responsibilities: Lead mechanical and systems engineering activities from concept to design transfer.
Collaborate with cross-functional teams (electrical, software, regulatory, manufacturing) to define system requirements and ensure seamless integration.
Design mechanical components and systems compliant with Class III medical device regulations with DFM, DTC, and DFA considerations.
Conduct design reviews, risk management (FMEA, ISO 14971), and verification/validation (V&V) with related documentation.
Prototype, test, and validate mechanical systems in a regulated environment.
Mentor junior engineers and support cleanroom practices.
Core Competencies: Education & Experience: Bachelor's in Mechanical, Biomedical, or Mechatronics Engineering (or equivalent), with 5-7 years in mechanical/systems engineering, preferably in Neurotech or Class III devices.
Technical Expertise: CAD (Solid Works, Fusion 360), prototyping, cleanroom manufacturing, DFM/DFA/DTC, risk management (ISO 14971), fixture/tooling design, and design transfer.
Teamwork & Leadership: Strong collaboration, project ownership, mentoring ability, and stakeholder communication.
Knowledge of ISO 13485, ISO 14971, FDA regulations.
Experience with implantable leads or minimally invasive devices.
Experience with PLM, FEA, CFD (ANSYS, Cosmos).
This role requires a proactive, hands-on engineer who thrives in a collaborative environment and is committed to delivering high-quality medical devices.
Seniority level Mid-Senior level Employment type Full-time Job function Engineering and Information Technology Industries Medical Equipment Manufacturing #J-18808-Ljbffr
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