Principal Design Assurance Engineer
We are seeking an experienced and motivated
Principal Design Assurance Engineer
(seniority dependent on background) to take a leading role in scaling our operations. This hybrid position will support manufacturing, facilities, and supply chain functions as the organisation moves from development into commercial launch.
This opportunity will suit someone who thrives in a fast-paced environment, enjoys working collaboratively across disciplines, and takes pride in delivering projects that make a genuine difference for patients.
Why Join Us?
* Play a key role as an early hire in a rapidly growing medical technology company.
* Contribute to the development of innovative, patient-focused products.
* Competitive salary and flexible benefits package.
* Comprehensive training and ongoing professional development.
* Supportive culture that values flexibility, work–life balance, and personal growth.
Responsibilities
* Lead and support Design Verification and Validation testing.
* Contribute to corrective and preventive action initiatives.
* Manage design control activities, including design reviews and process improvements.
* Prepare and maintain technical documentation for regulatory submissions.
* Develop and refine test methods, protocols, and associated work instructions.
* Support Human Factors and Usability studies.
* Influence product and process design decisions aligned with business goals.
* Provide coaching, mentoring, and guidance to colleagues.
* Ensure smooth transfer of activities from design to manufacturing (e.g. dFMEA to pFMEA, design to manufacturing specifications, test method transfer).
* Collaborate with external suppliers and design/manufacturing partners.
What We're Looking For
Personal Attributes:
* Innovative
– a creative problem-solver with enthusiasm for new ideas.
* Collaborative
– open to feedback and effective in multidisciplinary teamwork.
* Clear Communicator
– excellent written and verbal communication skills.
* Self-Motivated
– proactive, resourceful, and accountable.
* Organised
– able to prioritise tasks and meet deadlines consistently.
Essential Experience & Skills:
* Degree in engineering, science, or a technical discipline (ASQ CQE also accepted).
* 6+ years' relevant engineering experience in Design Assurance.
* Experience within ISO 13485 QMS or a comparable quality system.
* Strong background in design controls, design reviews, and design change processes.
* Expertise in FMEA (design and/or process).
* Proficient in root cause analysis and structured problem-solving.
* Competent with statistical tools and Microsoft Office (Excel, Word).
* Confident in liaising with both internal and external stakeholders.
Desirable Experience:
* Process or equipment validation.
* Previous experience in a start-up or SME environment.
* Knowledge of Design for Manufacture (DfM).
* Validation of test methods, test equipment, or software.
* Strong understanding of statistical techniques.
* Experience with sterile or electro-mechanical devices, particularly those incorporating software.