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Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results.
Here, you will find more than just a job—you will find purpose and pride.
JOB SUMMARY:
Perform requirement analysis, verifiability of requirements and Conduct design verification and validation (V&V) activities for products being developed for upcoming Hill-Rom products, as well as for updates to existing products.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
· Work closely with System Engineer and other development engineers in reviewing Design inputs / specifications for verifiability.
· Collaborates with System Engineer and own the development of verification plan, verification protocols and scripts based on Design Inputs.
· Develop accurate schedules and estimate overall System V&V schedule.
· Develop testing tools, when required, to execute V&V.
· Execute test scripts to ensure design output meets design input, identify design defects during verification.
· Create defect logs and support in defect management.
· Maintain traceability of Design Inputs to Design Verification.
· Develop and maintain required Design History Files relating to test records, results, and issue observations.
· Complete all applicable trainings and comply with applicable Quality System documents.
· Applies new technical tools and concepts under the direction of others.
· Documents status and results accurately and succinctly, and with purpose.
· Seeks input from more experienced individuals to improve quality of deliverables
· Other duties may be assigned.
EDUCATION AND EXPERIENCE:
· Bachelor or master’s degree in one of the following areas: Mechanical Engineering / Electronics Engineering, or equivalent field with strong analytical thinking.
· 5 years of experience in product verification / validation, electrical module testing, software / firmware testing.
QUALIFICATIONS AND SKILLS:
· Knowledge in Lab Instrumentation.
· Candidates shall have hands on experience with measuring & test equipment such as Data loggers, Oscilloscopes, Force gage, Load cells, Pressure sensors, Flow sensors, Pressure regulators/gauges, Calipers, Multimeter, Thermocouples and Strain gauges.
· The candidate shall have capability to set up and configure the test system.
· The candidate shall possess the capability to perform data analysis and write test reports.
· Knowledge of using statistical software to analyze and graph data will be an added advantage.
· Good verbal and written communication skill in Chinese and English.
· The candidate shall be capable of working independently
· The candidate shall be capable of setting priorities and do multi-tasking.
· Familiarity with FDA’s Good Documentation Practice
· Previous experience with Medical Devices is added advantage
· Knowledge of Medical device product development process
· Other Competencies: Result Oriented, Commitment to Continuous Improvement and Effective Teamwork
· Strong organization and communication skills.
· Proficient problem solving.
· Adaptable to change
Equal Employment Opportunity
Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race,…