Staff Integration and System Engineer
il y a 2 semaines
Description:
Stryker is one of the world’s leading medical technology companies and, together with our customers, is driven to make healthcare better. We offer innovative products and services in Orthopedics, Medical and Surgical, Neurotechnology and Spine that help improve patient and hospital outcomes.
We are looking for an ambitious and self-motivated Integration and System engineer. You will work closely with the development team to verify and validate the entire ecosystem and be involved in the release process ensuring high-quality product delivery. You will be capable of working with stakeholders such as regulatory and quality and have the flexibility and communication skills to operate effectively with other teams across Stryker.
What you will do:
- Work closely with the development team, the V&V engineers and the product owners to ensure the validation of the entire ecosystem,
- Be involved in the formalization process of developments by defining and organizing software requirements, tests, and validation protocols,
- Be involved with regulatory and quality teams to create and maintain the Design History File for our Medical Device software products,
- Establish a working relationship with stakeholders to successfully ensure proper software deliveries matching customer expectations,
- Ensure on-schedule delivery of high-quality products that meet technical and clinical requirements.
What you will need:
- Master's degree in software engineering / computer science or related discipline,
- 4+ years of work experience in integration and system engineer role and/or V&V role,
- Strong knowledge of medical device regulations: ISO 13485, ISO 14971, EN 62304,
- Experience in contributing to a Design History File for a Medical Device,
- Experience in formalizing software developments from technical and customer inputs to tests reports,
- Knowledge of agile software principles and software development life cycle in a domain with strong regulatory constraints,
- Strong verbal and written communication skills in English,
- Experience in medical software validation would be appreciated.
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