Senior Systems Engineer - Medical Devices

Senior Systems Engineer – Medical Devices Perth, WA | $140,000–$150,000 + super | Initial 12-month contract Imagine working on technology that could change the outcome of one of the most critical moments in a family’s life. This multi-award-winning Australian MedTech company is developing next-generation fetal monitoring technology designed to give clinicians clearer, real-time insight into the wellbeing of mothers and babies during labour. By combining advanced biosensors with connected medical-device technology, the team is working to support faster, better-informed clinical decisions when every moment matters. Backed by venture capital and years of clinical research, the business brings together specialists across systems engineering, electronics, software, firmware, clinical research, data science, quality and regulatory. They are now entering a pivotal stage of product development and need an experienced Senior Systems Engineer to help bring the complete medical system together. The opportunity This is a senior, hands-on individual contributor role suited to someone who enjoys working across the full product-development lifecycle. You will operate at the centre of a multidisciplinary engineering team, connecting product requirements, system architecture, hardware, software, firmware, testing and regulatory evidence. There are no direct reports attached to the position. The focus is on technical delivery, systems thinking and ensuring the complete product is designed, integrated, tested and documented to the standard required within a regulated medical-device environment. What you’ll be working on Developing and maintaining system requirements, architecture, interfaces and technical documentation.Translating clinical, product and regulatory needs into clear engineering requirements.Coordinating integration across mechanical, electronic, firmware and software components.Planning and supporting system integration, verification and validation activities.Maintaining requirements-to-test traceability and supporting risk-management activities.Investigating complex system-level issues and working across disciplines to identify root causes.Contributing to design reviews, technical decision-making and product-development planning.Producing the technical evidence and documentation required to support regulatory submissions.Working closely with engineering, manufacturing, clinical, quality and regulatory specialists. What we’re looking for We don’t expect you to know absolutely everything, but we are looking for a strong mix of the following: At least seven years of experience across systems engineering or multidisciplinary product development.Hands-on experience developing regulated medical devices.Experience taking a medical product through the later stages of development, verification and regulatory submission.Strong requirements engineering, system architecture, interface definition and traceability experience.Understanding of mechanical, electronic, firmware and software systems and how they interact.Experience with system integration, verification, validation and root-cause analysis.Familiarity with medical-device standards and quality systems such as ISO 13485, ISO 14971, IEC 60601 and IEC 62304.Exposure to FDA, TGA or comparable regulatory submissions.Confidence producing clear technical documentation, test evidence and design records.Experience with connected devices, sensors, monitoring systems or electro-mechanical medical products would be highly regarded. Why consider it? This is an opportunity to work on meaningful technology within a highly collaborative and technically diverse environment. You will have visibility across the complete product rather than being limited to one engineering discipline, with the opportunity to influence important technical decisions and help progress a genuinely innovative medical device. Next steps If you have experience bringing complex medical devices together across systems, hardware and software, we would love to hear from you. Apply now for more information and/or to be considered.