Engineer/Senior Systems Engineer
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System Engineer / Senior System Engineer
Location: Singapore or Sydney
We're looking for aSystems Engineer / Senior Systems Engineerto join our team and play a key role in supporting the lifecycle of innovative healthcare products used globally.
If you enjoy solving complex problems, working cross-functionally, and making a real impact on product quality and patient safety-this could be the role for you.
What you'll do
Support the ongoing lifecycle of released products, ensuring compliance with safety, quality, and regulatory standards
Maintain system requirements,riskmanagement files, and design documentation
Collaborate with cross-functional teams (Engineering, Quality, Regulatory, Manufacturing) to evaluate and implement product changes
Support investigation offield issues and customer feedback using structured root cause analysis
Contribute to post-market surveillance and risk management activities (e.g.,Hazard analysis, safety risk assessments)
Support verification & validation and ensure end-to-end traceability
Participate in design reviews, audits, and continuous improvement initiatives
For Senior Engineers:
Lead projects or workstreams independently
Mentor junior engineers and drive best practices
What you bring
Degree in Engineering (Biomedical, Mechanical, Materials, Chemical or similar)
3-5 years(Engineer) or5-8 years(Senior) experience
Experience in aregulated industry(medical devices, healthcare preferred)
Knowledge of design controls, risk management, and product lifecycle processes
Familiarity with ISO 13485 / ISO 14971 andverification andvalidationactivities
Strong problem-solving mindset and systems thinking
Why join us
Work on products that directly impactpatient outcomes globally
Collaborate with adiverse, cross-functional international team
Opportunity to grow acrossSingapore or Sydney locations
Be part of a culture that valuesquality, innovation, and continuous improvement
#LI-APAC
Joining us is more than saying yes to making the world a healthier place. It's discovering a career that's challenging, supportive and inspiring. Where a culture driven by excellence helps you not only meet your goals, but also create new ones. We focus on creating a diverse and inclusive culture, encouraging individual expression in the workplace and thrive on the innovative ideas this generates. If this sounds like the workplace for you, apply now! We commit to respond to every applicant.
Job ID: 153081489
Skills:
Systems Integration, Technical Documentation, statistical interpretation, engineering risk assessment, requirements interfaces traceability, Troubleshooting, root-cause analysis, hands-on engineering testing, test strategy and method development, acceptance criteria, design controls, Data Analysis, Experimental Design, verification concepts
Skills:
Agile Development Methodologies, Requirements Management, safety analysis, system verification and validation, systems engineering methodology
Skills:
lasers , Requirements Engineering, Physics, Simulation Software, Systems engineering, Optical design tools, Electronics Engineering, Verification validation plans, Optics, System design reviews, Electro-optical systems
Skills:
Iso 13485, quality management systems, Iso 14971, risk management processes, medical device regulatory standards, IEC 62304, Project Coordination, Technical Writing
Skills:
Jira, Polarian, Enterprise Architect, Doors, ISO IEC15288, ATM Domain, Human Factors Standards, Integration and Verification, Model Based Systems Engineering, Capella, Requirements Design, Validation, Systems engineering
