Job Id: 20201016016
Job Role: Systems Engineer, Principal
Experience: Relevant Experience
Qualification: Bachelors/Master’s Degree in Computer Science, Mechanical, Electrical, Biomedical Engineering or equivalent
Job Location: Bangalore
Salary: Best in Industry
Vacancies: Not Mentioned
Job Description Baxter Careers Job Vacancies for Principal Systems Engineer in October 2020:
The role is responsible for transforming the needs to the customer into the system and software requirements for the engineers and testers building new product. The successful candidate will work closely with a team of engineers, business owners and clinical experts in the development of new and exciting software products for the business. The role is critical for ensuring the user/marketing/product owner needs to final product releases – a portfolio of web-based Software Applications intended for medical use.
Work with customers, marketing, clinical experts, product owners to develop and refine user requirements.
Transform user requirements into system and software requirements.
Support the authoring of both functional, non-functional requirements and specialist requirements such as risk control measures through collaboration with risk analysts and cyber security experts.
Collaborate with the software verification team to ensure that requirements are well-written and can be efficient and effectively tested.
Understands & performs analysis of macro-level workflows, device integration changes in support of new or existing EMR implementation.
Understand the regulatory compliance requirements in product design for intended country of use.
Understand the labelling requirements in product design for intended country of use.
Resolve competing constraints between interrelated functions required to deliver the product to market.
Plan and execute system integration activities to minimize issues in verification and validation.
Document traceability from requirements to verification activities, and from requirements to design entities.
Resolve systems-related technical issues by applying problem solving tools such as cause and effect diagrams, Pareto charts, etc.
Adheres to Baxter Quality Management system & supports the quality audits
Essential Qualifications / Experience
Hands on experience on IEC 62304 and IEC 82304 standards.
Prior experience in building and integrating EMR systems
Demonstrated facilitation and negotiation skills in driving closure on product/program-related decisions/issues
In depth knowledge of the regulatory environment for Design, Develop and Manufacture of Medical products.
Demonstrated strong analytical and problem-solving skills
Excellent verbal and written communication skills
Success in working with multifunctional, global teams.
Excellent interpersonal/communication/influencing skills required.
Bachelors/Master’s Degree in Computer Science, Mechanical, Electrical, Biomedical Engineering or equivalent
Minimum of 10- 15 years’ experience in product development or related field, in medical products industry.
Familiarity with ISO, FDA and other regulatory standards
Demonstrated experience working with vendors with different models of engagement.
Desirable Qualifications / Experience
Knowledge of ISO 14971 is an added advantage.