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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in systems engineering, design control, and risk management within regulated environments, ensuring compliance with industry standards such as MDR, FDA, and ISO 13485. Proficient in translating stakeholder needs into clear requirements and collaborating with cross-functional teams to drive project success.
Highest-signal resume keywords
Systems EngineeringDesign ControlRisk ManagementRequirements EngineeringRegulatory Compliance
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Design Input/OutputTraceabilityVerification and ValidationAnalytical SkillsCommunication Skills
Soft Skills
CollaborationCross-Functional Teamwork
Tools & Technologies
PolarionALM Tools
Industry Keywords
Medical DevicesMDRFDAISO 13485ISO 14971
About the role
Key responsibilities & impact- Drive and support design control and product risk management activities in development projects
- Translate stakeholder needs into clear, high-quality system and subsystem requirements with end-to-end traceability
- Own and contribute to systems engineering documentation, including design input/output, product description, and risk documentation
- Support design verification and validation planning and execution with Test Engineering
- Participate in design reviews, change control, and impact assessments
- Ensure compliance with applicable regulatory and quality requirements
- Collaborate with cross-functional project teams to support timely project execution
Requirements
What you’ll need- Degree in engineering or a similar technical discipline
- Experience with systems engineering and design control in a regulated environment required for permanent position
- Experience with medical devices is an advantage
- Knowledge of risk management, requirements engineering, and traceability
- Experience working cross-functionally with R&D, Test, Quality, and Regulatory stakeholders
- Strong analytical and communication skills
- Experience with Polarion or similar ALM tools is an advantage
- Compliance knowledge of MDR, FDA, ISO 13485, and ISO 14971
Benefits
Comp & perks- Permanent position or 12-month temporary maternity cover position
- Collaborative and learning environment
- Strong focus on quality and high professional standards
- Good sparring and learning
- Real responsibility from the start
- Opportunity to build strong capability in systems engineering and regulated product development
- Collaboration with experienced colleagues in Systems Engineering, Test Engineering, and Product Development