At Hilo by Aktiia, we believe the key to improving cardiovascular health is to provide patients and physicians with a deeper understanding of the blood pressure pattern. Before Hilo, it was not possible to monitor cardiovascular health at scale.
We are an early-stage, venture-backed start-up that has raised over $96M from top-tier investors in Europe and the United States. We have developed and brought to market the world’s first continuous blood pressure monitor. Our technology is based on 18 years of research by our founders at the prestigious Swiss Center for Electronics and Microtechnology (CSEM). Aktiia's solution has been validated through extensive clinical trials and received a CE Mark as a Class IIa medical device under MDR leading to commercial access of approximately 43 countries worldwide.
To strengthen our team, we are seeking a highly motivated Sr. Software Quality Assurance engineer with experience in product and IT systems software development and validation (cybersecurity experience is a plus):
This position must primarily provide expertise and leadership in the areas of product software development using an Agile methodology and meeting the requirements of IEC 62304. Furthermore, we will be seeking an individual with experience validating IT systems. This position will work with Product Management, Operations, Software Engineering, Regulatory, and other Quality functional areas to ensure work is completed in accordance with internal procedures and medical device regulations. In addition, this role must be flexible for changing priorities and able to work without direct supervision.
Responsibilities:
* Ensure that the software projects are meeting regulations and quality standards (IEC 62304).
* Take ownership of software projects for regulatory compliance and champion for process excellence by driving their teams towards conformance at every stage of development.
* Handle the process for software releases for existing commercial products (e.g. mobile application, cloud).
* Create and review various software lifecycle project deliverables based on procedural requirements.
* Perform risk analysis and be responsible for risk management activities; determine, evaluate, and document software risks from product design to post-launch.
* Review software design and development documentation to ensure compliance with IEC 62304, which includes software requirements specifications, software architecture, software test plans (e.g. test cases), software test reports, and software release notices.
* Review traceability analysis and traceability reports to ensure project requirements have been met.
* Evaluate and disposition software anomalies.
* Create, review, and approve document change control requests as well as provide quality input to support closure (QMS updates, Procedural changes, etc.).
* Provide quality input to Complaint, CAPA investigations and execute corrective actions when applicable.
* Review and update Cybersecurity documentation.
* Please note that this role will not be responsible for any software development or software testing.
Requirements:
* Bachelor’s degree in a technical or scientific field.
* 5 - 8 years minimum experience in a quality or software engineering function in the medical device industry.
* Demonstrate team leadership skills and ability to independently prioritize, execute, and report on projects.
* Knowledge of ISO and FDA / Quality System Requirements (e.g. IEC 62304, MDR; ISO 13485; ISO 14971; FDA 21 CFR Part 820, Cybersecurity standards).
* Strong project and time management skills.
* Familiar with Risk Management as governed by ISO 14971 (e.g. process FMEA).
* Demonstrate creative and effective problem-solving for resolving complex issues.
* Ability to work on multiple tasks concurrently with changing priorities.
* Proficient with MS Teams, Word, Excel, PowerPoint, and eQMS systems.
* Pension.
* Competitive compensation package based on experience.
* Flexible work location (hybrid work schedule) and occasional international travel as required (10% of time).
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