Design Control and Risk Management Manager

Lausanne, Vaud, Switzerland       ·       Full time

About the job

The Design Control and Risk Management Manager is responsible to define and to promote the quality mindset across the product development lifecycle. He / She is responsible to facilitate compliance to applicable requirements during the product development cycle including, but not limited to Risk Management, Usability, Design Control, Design Change, Verification and Validation.

This position supports deployment and continuous improvement of design and development process to drive delivery of reliable, safe and performing devices.

Responsibilities

Design Control during the product development cycle:

• Ensure the interpretation and integration of applicable regulations and standards in the requirements (IEC 62304, ISO 14708, ISO 10993, IEC 60601 series, IEC 62366).
• Actively participate and drive in product development projects (HW/FW/SW) ensuring that design inputs are clear, concise, testable, consistent, appropriate and that design outputs confirm compliance to the design inputs.
• Review and approve design verification, test methods and validation test plans, protocols and reports.
• Collaborate with D&D and project stakeholders to provide quality technical support and facilitate the successful execution of the Design Control Process.
• Responsible for overseeing Quality Engineering definition and deliverables required within the Design Control process.
• Review and/or establish deliverables from the Design Control process including DHF & Medical Device files reviews.
• Define product inspection criteria and first article verifications on risk-based approach.
• Participate in Design Reviews and Phase Reviews.
• Assess change requests of devices for impact to design, determine supporting information required for implementation of changes.
• Partner with manufacturing sites and external suppliers to review and assess any design or process changes that may impact the product specifications or overall performance.
• Warrant the implementation of Design Control process according to applicable standards and regulations (MDR2017/745, ISO 13485, QSR 21 CFR part 820).
• Support maintenance of continuous improvement within the QMS.

Risk Management during the product development cycle:

• Assure understanding and compliance of risk management requirements within the device design and development of medical devices.
• Oversee the Risk Management process: Identify and manage risk throughout the development process and sustaining efforts with the appropriate definition and use hazard and hazardous situation analysis, harm, risk policy, FMEA, Post-Market Surveillance Reports, Risk Management Plans/Reports. Ensure product risk assessment efforts, including and not limited to design failure mode effect analysis, essential performance, SW safety classification.
• Support Benefit Risk determination.

About you

• Minimum Master’s degree in engineering or relevant Technical/Scientific degree (Mechanic, Electronic); at least 5-10 years related proven experience in Design Quality and/or Risk Management, ideally in AIMD.
• Experience in requirements analysis, including testable and measurable specifications.
• Experience with test methods and standards for the design, verification, and validation of medical device.
• Experience with reliability analysis and test methods and test method validation.
• Experience with appropriately assessing written design and device documentation as the principal advocate for compliance.
• Proficient in use of statistical analysis and associated tools (e.g. Minitab, etc.).
• Strong comprehension and demonstrated ability to apply critical regulatory standards to procedural updates and project deliverables (FDA CFR 820, ISO 13485, ISO 14971).
• Firm understanding of DFMEA, pFMEA URRA and Risk Management processes.
• Strong drive to be precise and thrive for consistency.
• Ability to manage complex projects, also cross-functional projects.
• Highly organized individual with strong planning and organizational skills.
• Ability to effectively lead without authority throughout all departments.
• High integrity.
• Results oriented and hands-on individual who enjoys working in an international, cross-functional environment in a fast-paced and growing company.
• Excellent communication and management skills.
• Demonstrates the following characteristics:
  • Daring: passionate, imaginative, committed, independent and innovative
  • Pragmatic: solutions-oriented, direct, results-driven, creative, and resourceful
  • Rigorous: professional, resilient, inquisitive, and collaborative
  • Empathetic: caring, honest, encouraging
  • Positive: energetic, enthusiastic with a can-do attitude
• Excellent English language proficiency.

Supervision

Reports to the Director Quality Assurance and will have three direct reports.

Apply for the job

Do you want to join our team as our new Design Control and Risk Management Manager? Then we’d love to hear about you!

Please click here to apply.