Senior Medical Device Engineer / Technical PM (Client facing)
Location
Perth, WA
Type
0.8 FTE, with strong potential to grow into full-time
Company Description
Innovate Medtech is a medtech innovation studio: a one‐stop shop for founders developing medical technologies. We blend business consulting with hands‐on science and engineering, supporting clients from early‐stage concept and hypothesis‐led experimentation through to ISO 13485‐compliant product development, regulatory strategy, and clinical readiness.
Our projects span the full medtech spectrum: from biosensors and wearables to Class II and Class III implantable devices. We deliver not only engineering, but the commercial thinking and client partnership that underpins successful medical innovation. With an international network of advisors and clients across Australia, Asia‐Pacific, Europe, and the U.S., Innovate Medtech combines global reach with deep technical and commercial expertise. We're proud of our positive, innovative culture: fast‐paced, creative, and collaborative. We're also dog‐friendly and child‐friendly; because life doesn't stop at 9 am. If you're a curious, hands‐on builder who enjoys solving hard problems and working with people who are genuinely trying to change healthcare, you'll thrive here.
Role Description
We are seeking a Senior Medical Device Engineer to join our team as a doer‐leader – someone who can take ownership of complex engineering programs while simultaneously managing clients, mentoring engineers, and driving delivery.
This is a broad, senior, client‐facing role that combines project leadership with rigorous engineering execution. You will lead and deliver programs across a diverse range of medtech domains – from design controls and V&V through to clinical trial readiness and ISO 13485 implementation – while acting as a trusted technical partner to our clients.
This role is not for someone who wants to sit behind a desk and execute tasks in isolation. Nor is it for someone who wants to manage projects without getting their hands dirty. You will do both. You will lead project streams, manage client relationships, mentor junior and mid‐level engineers, and still roll up your sleeves to do excellent engineering work, leading by example.
You will be placed across a diverse range of client programs, managing significant scopes of work within broader development portfolios. Experience in startup environments is highly desirable – we move fast, priorities shift, and we need someone who thrives in that kind of environment.
About You
You have 6‐10 or more years of experience in medical device development. You've worked with Class II or Class III medical devices and understand what design control really means in practice. You've written test protocols, reviewed V&V reports, and ideally, you've taken a device through a clinical trial. You understand ISO 13485 not as a checkbox exercise, but as a framework that makes products better and safer.
You are comfortable walking into a client meeting and presenting a complex technical situation clearly: without losing the room, and without losing the detail. You know how to manage scope conversations diplomatically and hold a boundary professionally. You don't hide from clients. In fact, you're probably at your best when you're working directly with them.
You might come from a materials, chemical, systems, mechanical, or electronics engineering background. What matters more than your specific discipline is that you think like a builder – resourceful, hands‐on, and solutions‐focused who is comfortable working on projects which span those disciplines. You're comfortable with managing vendors and relationships. You have tact in bringing people along for the journey with you. If you've worked in a medtech startup, founded one, or come out of a medtech consultancy, we want to hear from you.
Stanford Biodesign training (understanding of the Biodesign Process) is highly desirable and will make you stand out.
You don't need to have done everything on this list. But you need to be honest with yourself about what you bring, and excited about building the rest.
Key Responsibilities
Project Leadership & Client Engagement
* Lead major project streams across diverse medtech domains and client portfolios
* Manage client relationships and act as a senior point of contact across programs
* Clearly define, communicate, and manage scope, timelines, and deliverables
* Apply strong negotiation and stakeholder management skills to navigate scope changes and competing priorities
* Translate technical complexity into clear, actionable communication for both technical and non‐technical audiences
* Maintain professionalism and build long‐term client trust across every interaction
Engineering & Technical Delivery
* Execute hands‐on engineering across R&D, prototyping, and product development
* Lead and contribute to design control processes in line with ISO 13485 and regulatory expectations
* Develop and oversee verification and validation strategies and test method validation
* Support design for manufacturability and engagement with manufacturing partners
* Contribute to system‐level problem‐solving across mechanical, electronics, and software domains
Clinical, Quality & Regulatory
* Support or lead aspects of clinical trial planning and implementation
* Contribute to or support ISO 13485 QMS implementation and maintenance
* Ensure all development activities align with regulatory requirements for Class II and III devices
* Maintain high‐quality technical documentation aligned with design control requirements
* Mentor and support interns, junior and mid‐level engineers on technical execution
* Support internal capability development and knowledge sharing across the team
Must‐Haves
* 6‐10 or more years of industry experience in medical device development, engineering consultancy, or related fields
* Proven experience working with Class II or Class III medical devices
* Strong background in design controls, verification and validation
* Experience with test method development and validation
* Patent literacy and reverse engineering skills
* Demonstrated exposure to clinical trials or clinical readiness activities
* Experience working within or implementing ISO 13485 quality systems
* Strong client‐facing experience, including managing expectations across complex programs
* Excellent written and verbal communication skills – able to engage confidently with founders, clinicians, and technical stakeholders
* Ability to balance hands‐on technical execution with project and client leadership
* Full working rights in Australia and a valid driver's licence
* Background in systems, mechanical, or electronics engineering
* Experience working in startups or fast‐paced consulting environments – or founding a medtech company
* Experience in consulting and managing client relationships through to successful outcomes
* Biodesign training (Stanford Biodesign or equivalent framework)
* Experience across R&D, quality, and manufacturing interfaces
* Strong commercial awareness and business acumen
* CAD experience (SolidWorks, Fusion 360, or equivalent)
* Hands‐on maker or DIY mindset – someone who enjoys prototyping, tinkering, and solving problems creatively
* Customer‐facing experience outside of engineering (retail, hospitality, or service roles) is genuinely valued – it often signals exactly the kind of interpersonal awareness this role demands
Why Join Innovate Medtech
At Innovate Medtech, you'll work directly with the founders, clinicians, and innovators shaping the next generation of medical technology. You'll grow fast, contribute meaningfully, and never be bored.
You'll join a flat, high‐trust team that values autonomy, ownership, and doing great work. We don't do corporate "innovation theatre". We do real projects with real stakes, and we celebrate the people who show up and deliver.
We offer flexible working at 0.8 FTE, a genuinely collaborative culture, and a dog‐friendly, child‐friendly workplace.
This role is based in Perth, Western Australia, and requires regular in‐person availability. Remote work is not available for this position, and relocation assistance will not be provided. Applicants must have unrestricted work rights in Australia, as visa sponsorship is not available. A current Australian driver's licence is required, as the role involves travel for client work, laboratory visits, and site meetings. Given our international client base, occasional early‐morning or late‐evening calls may be required to accommodate different time zones. We are looking for someone who is genuinely interested in a long‐term role and excited about growing with Innovate Medtech.
How to Apply
If you are a senior engineer and doer‐leader with deep medtech experience, a track record of client‐facing delivery, and the kind of mindset that thrives across ambiguity and high stakes : we'd love to hear from you.
Please send your CV and a short cover letter telling us about yourself, your key projects, and what draws you to this kind of role. If you've read this far congratulations for your attention to detail. You will know that applicants that take the time and effort to put together a cover letter are viewed more favourably.
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