Software Quality Assurance Engineer - Medical Devices

Job content

Software Quality Assurance Engineer – Medical Devices

AMF Medical is a medtech start-up, based at EPFL’s Innovation Park, which is developing a novel insulin “patch pump”. This insulin management system will offer better treatment options for diabetes patients, especially type 1 diabetes young adults and children. You can find out more at www.sigipump.com. In addition to its uncompromising ergonomics, the pump has better accuracy and faster occlusion detection - among other advantages - than insulin pumps currently available. This pump is based on patented microfluidics technology developed in-house over the past 5 years. For detailed info on the pump technology see: https://player.vimeo.com/video/556101206.

Summary

The Software Quality Assurance Engineer will work independently to set up all the tools and procedures required to develop the firmware and software of our insulin injection system in compliance with IEC 62304 and ISO 13485. He/She will be responsible for documenting all software and firmware of the company, in compliance with established SOP’s of our quality management system. Our insulin management system is composed of different medical devices connected wirelessly, some with multiple processors. The successful candidate should be able to independently ensure software compliance to medical certification, working in collaboration with the QA/RA team. Flexibility and open-minded spirit are key to providing quality solutions in a cutting edge, multidisciplinary environment. The candidate must also be able to work independently and is welcomed to propose innovative approaches to quality that will facilitate the regulatory pathway for our connected wearable insulin pump. A hands-on approach is required.

Key Skills and Temperament

• Passionate about enhancing software development process and tools to make the development of firmware and software faster and more efficient.
• Structured technical mindset with great attention to detail, and prompt to document software activities.
• Committed to finding the best technical solutions to enable the best possible product and user experience.
• Highly satisfied to be accountable for delivering on-time products that exceed expectations.

Tasks and Responsibilities

• Set up all the tools and procedures required to develop the firmware and software of our insulin injection system in compliance with IEC 62304 and ISO 13485. Develop software standard operating procedures, software test methodologies, and software verification & validation protocols and reports.
• Write all software specifications.
• Drive risk management activities (hazard identification, risk assessment and risk control) for all software development and participate to overall project risk management activities with team.
• Advise and support engineers on regulatory compliance for Software and General Data Protection Regulation.
• Lead computer software validation used for the monitoring and measurement of requirements and used in the Quality Management System (AAMI TIR 36)
• Collaborate with team members to determine best practices and requirements for software.
• Develop product specifications with attention to system integration and feasibility
• Plan, track and schedule software deliverables
• Coordinate and oversee technical standards in collaboration with QA/RA team, including software coding standards, tools, and platforms.
• Ensure effective change control activities during the product life cycle.
• Create the required documentation (design history file) for each software release.
• Create and support test protocols for the verification and validation of hardware and embedded software.
• Partner closely with other team members to successfully bring the prototypes in clinical study and obtain regulatory approvals.
• Independently manage third-party vendors including software components providers.

Education, Training and Experience

• Master’s degree in software engineering or equivalent plus 5 years’ work experience.
• Outstanding knowledge of IEC 62304. Shall have already implemented the necessary process and tools to develop firmware and software according to this standard.
• Fluent in French, excellent in English.
• Experience with FDA software validation, Cybersecurity, Data Protection and Artificial Intelligence guidances.
• Deep knowledge of software engineering, both process and tools (incl. continuous integration and testing).
• Experience performing software risk management for Class IIa (or higher) medical devices.
• Solid experience in structured product development (requirements-driven engineering, architecture modeling, detailed design, SW FMEA, formal verification, release processes, etc.).
• Experience with development within an ISO 13485 certified QMS.
• Demonstrated ability to work within a fast-paced start-up environment in a small team setting.
• Comfortable working autonomously and also as a team player.
• Experience and/or specialization in one or more of the following areas:

- Health software – IEC 82304-1

- Standards for Cybersecurity – UL 2900-1, IEC 62443 series, FDA guidances

- Guidances on Software as a Medical Device

- Experience in the application of ISO 14971 to medical device software and link with IEC 62304

- Artificial Intelligence is a plus

- Experience in C and C++ language

- Medical electrical equipment – IEC 60601 series

- General Data Protection Regulation (EU) 2016/679

Organizational Relationships

• Reports to Product Development Director

We Offer

• A high-tech and innovative environment in Medtech.
• Excellent working conditions, autonomy, being part of a motivated and highly qualified team.
• Very interesting and stimulating work in an innovative field with high potential.
• A pleasant environment within the EPFL Innovation Park, with possibility to benefit from the campus infrastructure.