Engineer/Senior Systems Engineer
MEDIFOX DAN GmbH
Apply to this jobSystem Engineer / Senior System Engineer
Location: Singapore or Sydney
We’re looking for a Systems Engineer / Senior Systems Engineer to 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, risk management files, and design documentation
Collaborate with cross-functional teams (Engineering, Quality, Regulatory, Manufacturing) to evaluate and implement product changes
Support investigation of field 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) or 5–8 years (Senior) experience
Experience in a regulated industry (medical devices, healthcare preferred)
Knowledge of design controls, risk management, and product lifecycle processes
Familiarity with ISO 13485 / ISO 14971 and verification and validation activities
Strong problem-solving mindset and systems thinking
Why join us?
Work on products that directly impact patient outcomes globally
Collaborate with a diverse, cross-functional international team
Opportunity to grow across Singapore or Sydney locations
Be part of a culture that values quality, 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.
Summary
Support healthcare product lifecycle, ensure safety compliance, lead projects, mentor teams
Job title
Engineer/Senior Systems Engineer
Experience level
3-5 years for Engineer, 5-8 years for Senior
Minimum experience
3+ years exp
Industry
healthcare
Location requirements
Singapore or Sydney, remote work optional
Salary
Not specified
Visa sponsorship
H-1B sponsor history
Management role
No
Required skills
Preferred skills
Specializations
Structured locations inferred from the posting.
Singapore
Sydney NSW, Australia