Systems Engineer Risks and Safety Standards

Actalent; Risch-Rotkreuz; Vor Ort; CHF 100.000 - 140.000; Vollzeit

Zusammenfassung

Actalent is seeking an experienced Systems Engineer for a 1-year contract in Rotkreuz, Switzerland, to support product risk, safety and compliance across the medical device lifecycle.

You will lead FMEA workshops, manage risks, review safety concepts, support verification and validation from a safety perspective, and maintain documentation in line with ISO standards.

Qualifikationen

• Degree in electrical, mechanical or software engineering or physics.
• Several years of experience in product development within regulated industries.
• Experience with risk management, design controls, GMP and quality processes.
• Strong understanding of systems engineering principles and development lifecycles.
• Excellent documentation and stakeholder management skills.

Aufgaben

• Lead and facilitate FMEA workshops with multidisciplinary engineering teams.
• Identify, assess, and mitigate product risks throughout development.
• Review and improve hardware and software safety concepts, including functional safety aspects.
• Support verification and validation activities from a safety and compliance perspective.
• Maintain technical documentation in accordance with applicable standards and quality requirements.
• Coordinate work packages and communicate progress to project stakeholders.

Kenntnisse

FMEA workshops

Risk management

Systems engineering

Documentation

Stakeholder management

Compliance

Ausbildung

Bachelor's degree in Electrical Engineering

Bachelor's degree in Mechanical Engineering

Bachelor's degree in Software Engineering

Physics

Jobbeschreibung

Our client, a global leader in healthcare diagnostics based in Rotkreuz, Switzerland, is looking for an experienced Systems Engineer to support product risk, safety, and compliance activities across the medical device development lifecycle.

This role is ideal for someone with a strong systems engineering background who enjoys working on product safety, risk management, functional safety, and compliance within highly regulated environments.

This is a 1 year contracting opportunity with likelihood of extension.

Responsibilities

• Lead and facilitate FMEA workshops with multidisciplinary engineering teams
• Identify, assess, and mitigate product risks throughout development
• Review and improve hardware and software safety concepts, including functional safety aspects
• Support verification and validation activities from a safety and compliance perspective
• Maintain technical documentation in accordance with applicable standards and quality requirements
• Coordinate work packages and communicate progress to project stakeholders

Requirements

• Degree in Electrical Engineering, Mechanical Engineering, Software Engineering, Physics, or similar
• Several years of experience in product development within regulated industries
• Experience with risk management, design controls, GMP, and quality processes
• Strong understanding of systems engineering principles and development lifecycles
• Excellent documentation and stakeholder management skills

Nice to Have

• Experience with ISO 14971, IEC 60601-1, IEC 61508 and/or IEC 62304