Sr. Instrument Verification and Validation Engineer
Sr. Instrument Verification and Validation Engineer
Posted on :
12-06-2025
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1 Vacancy
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Job Description
Responsibilities:
- Designing and implementing software of embedded devices and systems.
- Designing developing coding testing and debugging system software.
- Develop Requirements based manual test procedures.
- Access requirements for testability and determine best test approach.
- Compile and analyze test results.
- Document and manage system software defects.
- Participate in regular scheduling and team meetings.
- Participate in regular off hour meetings with partner in China.
- Understand project goals and timelines and provides support to ensure product launch success.
- Perform other work- related duties as assigned.
- B.S. or M.S. Degree in Computer Science Chemistry Biochemistry Biology Engineering or a related discipline required.
- 10 years required preferably in a medical device environment.
- Familiarity with software configuration management tools defect tracking tools and peer review.
- Instrument V&V Theory & Application.
- An understanding of IEC 62304 (Medical Device Software Lifecycle process) ISO 13485 ISO / EN ISO 14971 and FDA QSR experience or equivalent FDA software development requirements.
- Good analytical and problem-solving skills.
- Good organizational skills and the ability to manage multiple tasks.
- Experience in product development and experimental design.
- Ability to work within cross-functional teams.
- Strong communication skills written and verbal.
- Must exhibit professionalism confidence maturity desire to succeed and a self-motivated and proactive orientation.
- Ability to participate in planning and managing projects.
- Working knowledge of product development tools and processes (e.g. Design Input Design Output Verification and Validation Product Risk Management).
- Knowledge of related quality systems regulations and processes.
- Appropriate computer skills (e-mail word processing statistical spreadsheet and graphing software).
- Knowledge of Application life cycle management (Agile method preferred).
- Know and understand the software test cycle.
- Ability to write test plans test cases and test reports.
Employment Type
Full Time
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