What will you do
At Draeger, our work is dedicated to protecting, supporting and saving lives. We are looking for a talented individual to join our patient monitoring team to help deliver new features and product enhancements that will improve patient outcomes and reduce the cost of medical care around the world.
Projects at Draeger range from developing new software for acquiring, archiving, and displaying new monitoring data in a desktop or mobile application to developing software for new hardware modules. The ability to work in more than one of these areas is highly valued at Draeger. *Salary will commensurate with experience* **This position does not offer a relocation package**
As a member of a development team, you will:
Who you are Medical device industry experience is a requirement .
- Provide Quality Engineering support for the software organization during Design & Development.
- Provide support throughout the product Software lifecycle by participating in Software development reviews, code reviews and formal software technical reviews.
- Represent Software Quality on Project Cross Functional Teams
- Ensure Software development activities and deliverables meets the Quality and Regulatory requirements of FDA and ISO standards.
- Participate in Risk Assessment activities
- Review and approve new and modified Software product designs for quality characteristics, testability and traceable to product requirements.
- Review and approve test plans and results
- Review and ensure DHF compliance for all software deliverables
- Participate in software complaint and triage process
- Work cross-functionally with Quality, Regulatory, Product Qualification (PQ), Supply Chain, and Manufacturing
- Perform work in compliance to all relevant internal SOPs and FDA/industry regulations
- Performs other duties as needed and assigned within Software Quality Organization.
- Education: BS in relevant engineering discipline (e.g. Biomedical, Electrical, Computer Science, or Software Engineering).
- 3 to 5 years of experience working within medical device Quality organization
- Software engineering/development experience of medical devices software a plus
- Ability to effectively work on Project teams.
- Understand the internal processes and intent of all aspects of the QMS related to Design Controls
- Good interpersonal and communication skills
Special Competencies or Certifications: Understanding of IEC62304, ISO 13485, ISO 14971, ISO 9001and IEC 60601-1
- Knowledge of 21CFR820 and cGMP
- Familiarity with source code control, requirements management, and defect tracking software; JIRA, GIT/Bit Bucket, Rational ClearQuest, DOORs experience is a plus
- Proficient with the use of MS Office Products (Word, Excel, PowerPoint).
REMINDER: **compensation commensurate with experience** AND **this position does not offer a relocation package