Distinguished Systems Engineer

Ingelheim am Rhein System Vollzeit Unbefristetes Dienstverhältnis m/w/x
Technologien und Skills
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Deine Rolle im Team
  • In collaboration with a variety of experts from diverse professional backgrounds, you will drive the excellence of BI in building medical software from the spark of the first idea to a commercial product and further along the whole lifecycle.
  • As Distinguished Systems Engineer you ensure delivery of development and operations of products according to specified methodology.
  • With your strategic expertise, you define, architect, develop and manage a BI X software product in its complete lifecycle.
  • You'll be a key technology and process leader at BI X and intimately involved in almost every aspect of a solution lifecycle from project inception, engineering design, implementation to maintenance, risk management and continuous improvement.
  • Therefore, you always have an eye on compliance with BI guidelines/standards and continuous improvement when developing high quality applications in the medical space.
  • Furthermore, with your excellent coaching abilities you guide and develop less experienced colleagues.
Unsere Erwartungen an dich

Qualifikationen

  • We are looking for a person, that is open minded and fluent in application development and many technologies.
  • You are ideally a practitioner who knows that collaboration with the team is key to long-time success. Because of this mindset, you also inspire others in the team and are always on hand as a coach and mentor when difficulties arise.
  • English working proficiency and communication skills (verbal and written), German is a plus
  • Know-How in the area of software testing such as manual, automated, smoke, black box, regression, system and integration testing
  • Comfortable with large projects in source control and continuous integration and delivery
  • Knowledge in at least one of the following technologies: Java (Spring), TypeScript, Python, Scala, PostgreSQL, Go
  • Knowledge of development stack tools, e.g. Git, Docker, Kubernetes, OpenShift, Jenkins, Terraform, AWS is a plus
  • Knowledge of infrastructure and documentation as code is a plus
  • Actively communicate and build the medical devices software engineering vision of BI X
  • Curious mindset, keeps up with the latest technological advancements and contributes actively to the engineering community
  • Team player, able to work within a broader context

Erfahrung

  • Despite multiple years of experience, you are an active learner and are excited about driving change and continuous improvements.
  • First-hand experience of the intense collaboration in an agile software development team
  • Several years relevant job experience including product development and operations related to SaMD classified as class 2 and/or class 3
  • Demonstrated applied expertise in EU Medical Device Directives and FDA design control requirements (21 CFR 820.30) as applied to medical device software and medical device regulations including ISO 13485, ISO 14971, and IEC 62304
  • Experience in the creation and implementation of system engineering Standard Operating Procedures with particular attention in the addition of exploratory prototyping phases, integrating risk management, Human Factor/Usability Engineering, cybersecurity and medical device development lifecycle
  • Experience developing cross-platform and native mobile applications is a plus
  • Considerable experience of managing external suppliers

Ausbildung

  • Bachelor's or Master's degree in Bioengineering, Biomedical Engineering, Computer Science or similar

Interesse bekunden

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Quellen Information

Job: Distinguished Systems Engineer - SaMD @ BI X

Seite: boehringer-ingelheim.com

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