Systems Engineer Risks and Safety (m/f/d)

Work Selection AG; Rotkreuz; Vor Ort; CHF 110.000 - 140.000; Vollzeit

Benefits dieser Stelle

On-site parking

Staff restaurants

Mobility discounts

Onboarding program

Professional development

Zusammenfassung

Roche Diagnostics in Rotkreuz seeks a Systems Engineer Risks and Safety for a 12-month assignment with a high probability of extension. You will help ensure safety and performance of medical and IVD devices across the lifecycle, focusing on ISO 14971, IEC 60601-1, IEC 61508 and IEC 62304.

As part of the Standards & Product Risks team, you will drive risk assessments, document CB tests and maintain compliance, collaborating with engineers to deliver reliable, safe products on a global stage.

Qualifikationen

• Degree in Electrical/Mechanical/Software Engineering, Physics, or similar.
• More than 3 years of experience in product development.
• GMP experience, experience with design controls, good documentation practice, design transfer, risk management, and quality process compliance.
• Fluent English.
• Familiarity with ISO 14971, IEC 60601-1, IEC 61508 and IEC 62304 is preferred.

Aufgaben

• Organize and execute failure mode and effects analysis with a team of engineers.
• Identify hazards and risks in the 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

GMP experience

Design controls

Risk management

Documentation practice

Quality process compliance

Fluent English

3+ years product development

Ausbildung

Electrical/Mechanical/Software Engineering or Physics

Jobbeschreibung

As a first-tier supplier to our renowned business partner Roche Diagnostics in Rotkreuz, we are currently looking for a motivated and dedicated Systems Engineer Risks and Safety, for a temporary assignment of 12 months, with high probability of extension. In the field of Near Patient Care, Roche shapes the future of diagnostics directly at the patient’s side. The company is looking for a Systems Engineer who is passionately committed to designing reliable products and maintaining compliance throughout the product lifecycle. As part of the Standards & Product Risks team, you will ensure the safety and performance of medical and IVD devices. The Perfect Candidate possesses extensive expertise in medical device system development, with a deep understanding of compliance for critical risk and safety standards, including ISO 14971, IEC 60601-1, IEC 61508, and IEC 62304. They offer comprehensive experience across the systems engineering lifecycle - from requirements engineering to architecture, system integration, usability engineering and verification & validation (V&V). Furthermore, they demonstrate proficiency in risk management, safety/reliability engineering and product lifecycle management, alongside a proven ability to rapidly master complex technologies and navigate rigorous regulatory documentation.

Tasks & Responsibilities

• Organize and execute failure mode and effects analysis with a team of engineers
• Identify hazards and risks in the 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

• A degree in Electrical/Mechanical/Software Engineering, Physics, or similar
• More than 3 years of experience in product development
• GMP experience, experience with design controls, good documentation practice, design transfer, risk management, and quality process compliance
• Fluent English

Nice-To-Have

• German skills

Benefits

• Become part of one of the most prestigious pharmaceutical companies and actively shape the future of healthcare
• Experience a work culture that promotes diversity and inclusion and where all employees feel valued
• Work on a state-of-the-art campus featuring green spaces, meeting areas, and an inspiring atmosphere
• Work with modern and up-to-date tools in an innovative work environment
• Start with a professional onboarding process and a thorough introduction to your new role during the Welcome Days
• Benefit from financial support for your professional development plans
• Enjoy a selection of high-quality meals in modern staff restaurants
• As part of a sustainable mobility concept, on-site parking spaces are available to you (subject to eligibility criteria)
• Take advantage of unbeatable, year-round discounts at renowned retailers and over 200 top brands
• Benefit from fleet discounts when purchasing new cars or receive constant fuel discounts with our fuel card