Requirements: English
Company: WhatJobs
Region: Dagmersellen , Lucerne
Position:
As the Device Safety Manager - Product Safety and Regulatory (m/f/d) you will perform following tasks:
Operational Compliance Execution:
- Manage compliance activities for RRP devices and accessories in accordance with established safety and regulatory frameworks.
- Implement and execute testing and validation protocols to ensure compliance with all required standards.
- Identify and report any safety or regulatory issues to the QA RRP management, ensuring proper documentation and corrective actions are taken.
Technical Risk Assessment:
- Conduct risk assessments using established methodologies, including FMEA, to identify and mitigate potential safety risks.
- Collaborate with internal teams to execute detailed analyses that verify product safety and compliance.
- Ensure robust documentation and reporting of risk assessment activities.
Compliance Testing and Validation:
- Oversee internal compliance validations and coordinate external laboratory testing efforts.
- Ensure all testing follows established timelines and programs.
- Document and analyze validation results, preparing technical reports and proposing improvements to testing processes.
Technical SQI Investigation Support:
- Provide technical support for investigating Serious Quality Incidents (SQIs) that relate to product safety or regulatory non-compliance.
- Collaborate with testing laboratories to identify root causes of issues and implement corrective actions.
Cross-Functional Collaboration:
Work closely with R&D, Manufacturing, Legal, and external partners, including subcontractors in China and project management teams in Geneva and Tokyo.
Lead efforts to implement and uphold safety and compliance requirements during product development and launch.
Foster strong collaboration across functions to ensure the timely and successful completion of compliance tasks.
Compliance Documentation:
- Develop and maintain technical documentation that meets compliance and regulatory standards.
- Prepare detailed reports and records to support internal audits and regulatory submissions.
- Operational Excellence:Continuously assess and improve compliance processes and workflows, as well as identify opportunities for operational efficiencies while ensuring thorough compliance validation.
Requirements:
- Degree in Electronics Engineering, Physics, or related technical field.
- A minimum of 5 years of experience in product safety testing and validation, with a strong background in analyzing and certifying the safety of electronic devices or similar products.
- Proficiency in technical writing, risk assessment methodologies (e.g., Hazard Analysis and Risk Assessment HARA, FMEA), electrical safety testing, and consumer electronics standards (IEC, EMC). Experience with lithium-ion battery, battery management systems (BMS) safety. Strong knowledge of compliance validation for electronic consumer products. Familiarity with cybersecurity requirements for connected devices, including standards such as EN, ETSI, and the EU Cyber Resilience Act (CRA), would be an advantage
- Fluency in English (additional language skills are a plus).
- Advanced Excel skills for analyzing risk and managing compliance data. Experience with MS Office and SAP is required.
- Strong technical thinking, critical decision-making skills, and the ability to coordinate with multiple stakeholders, both internal and external. A proactive, open-minded approach to problem-solving is essential.
- Collaboration and Team Dynamics:The role will require close interaction with various internal departments such as PMO, Legal, R&D, and other stakeholders. You will manage relationships with external testing laboratories andODM partners responsible for the development, validation, and manufacturing of RRPs and accessories.
- Team Management: While this role may not directly manage large teams, it involves cross-functional leadership and coordination, ensuring compliance across teams and regions.
- Travel Requirements : This role involves travel to key locations for compliance activities and regulatory oversight, including Japan, China, South-East Asia an EU.Travel is expected 2 to 4 times per year.
What to expect:
Expect wellbeing initiatives, flexible work arrangements, growth opportunities, and excellent benefits, including a unique family leave policy. For more details on local policies, speak with the Talent Advisor.
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Next Steps:
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