Principal Design Assurance Engineer | Technical Lead | Medical Devices
Benefits
Operate at Principal level, solving complex technical and design challenges
Influence critical decisions across high-risk, implantable medical device development
Stay hands-on technically while gaining greater strategic influence and autonomy
Across design, systems, risk and V&V; – not just Quality
Become a technical mentor and help shape Design Assurance capability
About the Company
Join an innovative Sydney-based medical device organisation developing sophisticated implantable technology for patients globally.
You'll join in a multidisciplinary environment alongside experienced Engineering, Systems, Quality, and Regulatory professionals, contributing to technically complex products where strong engineering judgement is critical.
About the Opportunity
This isn't a traditional Quality role.
It's a Principal level technical position within Design Assurance for an experienced engineer who enjoys getting into the difficult problems: challenging designs, interrogating technical evidence and helping teams find the right path when the answer isn't obvious.
You'll collaborate with Product Development to ensure design decisions, risk controls and V&V; strategies are technically robust, and you'll play a key role when regulators come asking questions.
Your influence will come from technical credibility, sound judgement and the ability to guide others through complex problems.
What You'll Be Doing
Acting as a senior technical voice across complex medical device development programs
Challenging and guiding Engineering on critical design and product decisions
Applying design controls and ISO***** risk management throughout development
Reviewing requirements, architecture, risk controls and V&V; evidence




Contributing substantially to complex technical investigations alongside Product Development
Responding to regulator questions and supporting regulatory submissions
Mentoring engineers and strengthening Design Assurance capability across the team
Why It's Worth It
Take the step from Senior Engineer to genuine Principal level influence
Tackle challenging technical problems rather than simply reviewing documentation
Build your career on technical depth without needing to pursue people management
Work on sophisticated technology where risk, reliability and patient safety matter
What You'll Bring
Significant experience developing regulated medical devices
Deep technical capability across Design Assurance, Systems Engineering, V&V;, Design Quality or Product Development
Strong understanding of design controls, ISO*****, ISO***** and 21 CFR 820
Experience supporting regulatory submissions and responding to regulator queries
Strong regulatory judgement: you know not only whether something works technically, but whether the rationale and evidence will withstand scrutiny
Confidence challenging experienced engineers and recommending alternative approaches
Experience mentoring and developing technical capability in others
Experience with Class II/III, implantable, connected or software-driven devices is highly regarded
Culture
You'll join a technically driven, collaborative workplace where Quality and Engineering work closely together.
This role suits someone who asks "why?", challenges assumptions and enjoys working through difficult problems with experienced engineers.
You'll be trusted to contribute your expertise, recommend solutions and help others develop stronger technical judgement.
If you're an experienced Principal Engineer, Design Assurance Engineer, Systems Engineer, V&V; Engineer or Design Quality Engineer looking for greater technical ownership and influence, we'd like to hear from you.
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📌 Principal Design Assurance Engineer (Sydney)
🏢 Healthcare Professionals Group
📍 Sydney