Location
Melbourne, VIC
Overview
A fast-growing medical device startup developing a novel gastrointestinal endoscopy. Their mission is to transform minimally invasive diagnostics and improve patient outcomes through advanced engineering and thoughtful design. They have received FDA approval for their device towards the end of 2025. The Senior Medical Device Engineer will play a critical role in the development and commercialization of the endoscopic platform. This person will be working in a team to ensure that engineering deliverables align with functional requirements, project timelines, regulatory requirements, and medical device quality standards, and validating prototypes on the bench and with clinicians.
Responsibilities
* Participate in engineering activities with internal teams and external manufacturing partners
* Support with the final design and development of the commercial product
* Conducting design verification and validation activities
* Support with design control documentation and ensure compliance with ISO 13485
* Contribute to preparation of regulatory submissions, including FDA 510(k) documentation
* Identify technical risks and implement mitigation strategies to support project milestones
* Develop scalable manufacturing processes and supplier quality controls
* Collaborate with cross-functional teams including regulatory, quality, and clinical advisors
Qualifications
* Bachelor's degree in biomedical or mechanical engineering or equivalent
* Extensive experience in medical device development (minimally invasive or endoscopic systems)
* Demonstrated experience working under ISO 13485 quality systems and design controls
* Engineering experience in electronics, mechatronic or electro-optical design would be highly regarded.
* Experience contributing to FDA submissions is highly desirable
* Experience of working with external vendors and contract manufacturers
* Strong understanding of product development lifecycle from concept through commercialization
* Excellent problem-solving, communication, and organizational skills
* Ability to work effectively in a startup environment
Benefits
* Competitive salary package (negotiable - based on experience)
* Ground-floor opportunity to help shape a novel medical technology
* A key role with significant impact in a rapidly growing startup
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