Senior Systems Engineer — Healthcare Systems & Compliance

Worklane GmbH; Singapore; On-site; SGD 116,324 - 193,873; Full time

Job summary

Worklane GmbH in Singapore or Sydney seeks a Systems Engineer to support the lifecycle of innovative healthcare products used globally. You will ensure safety, quality, and regulatory compliance while working with cross-functional teams across engineering, quality, regulatory, and manufacturing.

The role requires a degree in engineering and 5–8 years of experience in a regulated environment, with strong knowledge of design controls, risk management, and V&V activities.

Qualifications

• Engineering degree required (Biomedical, Mechanical, Materials, Chemical or similar).
• 3–5 years (Engineer) or 5–8 years (Senior) experience in engineering roles.
• Experience in regulated industries (medical devices, healthcare preferred).
• Knowledge of design controls, risk management, and product lifecycle processes.
• Familiarity with ISO 13485 / ISO 14971 and verification & validation activities.
• Strong problem-solving mindset and systems thinking.

Responsibilities

• Support ongoing lifecycle of released products, ensuring safety, quality, and regulatory compliance.
• 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.

Skills

Regulatory mindset

Risk management

Design controls

V&V familiarity

ISO 13485 / ISO 14971 knowledge

Systems thinking

Education

Engineering degree

Job description

Worklane GmbH in Singapore or Sydney seeks a Systems Engineer to support the lifecycle of innovative healthcare products used globally. You will ensure safety, quality, and regulatory compliance while working with cross-functional teams across engineering, quality, regulatory, and manufacturing.

The role requires a degree in engineering and 5–8 years of experience in a regulated environment, with strong knowledge of design controls, risk management, and V&V activities.