Systems Engineer Risks and Safety Standards

ELAN Personal AG; Risch-Rotkreuz; Hybrid; CHF 110.000 - 150.000; Vollzeit

Benefits dieser Stelle

Home office up to 50%

Modern campus with green spaces

Dynamic team of 15

Zusammenfassung

Roche Diagnostics International AG in Rotkreuz is seeking a Systems Engineer Risks and Safety Standards to drive reliability and compliance across the product lifecycle.

You will join the Standards & Product Risks team to ensure safety and performance for medical and IVD devices at patient side.

Qualifikationen

• Degree in Electrical/Mechanical/Software Engineering, Physics or related field.
• 3+ years in product/system development, ideally in the medical device industry.
• Experience across the systems engineering lifecycle: requirements, architecture, integration, and V&V.
• Hands-on experience with risk management, safety/reliability engineering and design controls.
• Good knowledge of ISO 14971, IEC 60601-1, IEC 61508 and/or IEC 62304.
• Experience with GMP, design transfer, good documentation practices and quality processes.
• Fluent English; German is a plus.
• Strong ability to work with complex technologies and regulatory documentation.

Aufgaben

• Organize and execute failure mode and effects analysis with a team of engineers.
• Identify hazards and risks in context of product risk management.
• Revise HW & SW system safety and reliability concepts, incl. functional safety.
• Oversee execution and documentation of tests within the certification board scheme (CB report).
• Update and provide corresponding documentation according to internal and external standards.
• Workpackage and task planning & reporting to project stakeholders.

Kenntnisse

Systems engineering lifecycle

Risk management

Documentation practices

English proficiency

Regulatory awareness

Ausbildung

Electrical/Mechanical/Software engineering or Physics

Jobbeschreibung

Roche Schweiz bridges the gap between pharmacy and diagnostics. Important research and development functions are located here. For our longtime client, Roche Diagnostics International AG in Rotkreuz, we are looking for an:

Systems Engineer Risks and Safety Standards

Background:

In the field of Near Patient Care, Roche is shaping the future of diagnostics directly at the patient's side.

They are looking for a systems engineer who is passionately committed to designing reliable products and to maintaining compliance throughout the product lifecycle. As a part of our Standards & Product Risks team, you will ensure the safety and performance of our medical and IVD devices.

Tasks & Responsibilities:

• Organize and execute failure mode and effects analysis with a team of engineers
• Identify hazards and risks in context of product risk management
• Revise HW & SW system safety and reliability concepts, incl. functional safety
• Oversee execution and documentation of tests within the certification board scheme (CB report)
• Update and provide corresponding documentation according to internal and external standards
• Workpackage and task planning & reporting to project stakeholders

Must Haves:

• Degree in Electrical/Mechanical/Software Engineering, Physics or a related field
• 3+ years of experience in product/system development, ideally in the medical device industry
• Strong experience across the systems engineering lifecycle, including requirements engineering, system architecture, integration and V&V
• Hands-on experience with risk management, safety/reliability engineering and design controls
• Good knowledge of relevant standards, particularly ISO 14971, IEC 60601-1, IEC 61508 and/or IEC 62304
• Experience with GMP, design transfer, good documentation practices and quality processes
• Fluent English - German is a plus
• Strong ability to work with complex technologies and regulatory documentation

What is offered to you:

• A chance to contribute to one of the most significant diagnostic companies in the world.
• A modern campus with plenty of green spaces and meeting areas.
• Central location with highway access and train station nearby.
• Diversified activity profile.
• Home office possibilities up to 50%
• Participation in a dynamic and motivated team of 15 members