Principal Eng, SystemsReq # JR - 024126 Location Bengaluru, Karnataka, India Additional Locations 56 Job Category Research and Development Date posted 07/30/2020
Are you looking for a career that matters?
We believe every person deserves a chance for a healthy life, free from illness and full of possibility. We see a world full of healing, with viable care options available to those with limited choices today. We envision new ways of providing physicians, pharmacists and nurses with technologies that not only treat chronic diseases, but also work to prevent them. We’re looking for team members who are motivated to learn, grow and innovate, while making a meaningful difference for millions of people around the world.
Learn more about how Baxter is At the Intersection of Saving and Sustaining Lives.
Baxter provides a broad portfolio of essential renal and hospital products, including home, acute and in-centredialysis;
sterile IV solutions; infusion systems and devices; parenteral nutrition; surgery products and anesthetics; and pharmacy
automation, software and services. The company’s global footprint and the critical nature of its products and services
play a key role in expanding access to healthcare in emerging and developed countries. Baxter’s employees worldwide
are building upon the company’s rich heritage of medical breakthroughs to advance the next generation of healthcare
innovations that enable patient care.
About the Role
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.
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.
A Career That Matters
Baxter’s employees are united in a mission to save and sustain lives. We are passionate about applying scientific
innovation to meet the needs of the millions of people worldwide who depend on our medically necessary therapies and
technologies. We focus on increasing access to healthcare, innovating in crucial areas of unmet need, and pursuing
creative collaborations that bring our mission to life for patients every day.
Equal Employment Opportunity
Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion,
gender, national origin, age, sexual orientation, gender identity or expression, disability/handicap status or any other
legally protected characteristic.
Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an e-mail to Americas_TTA@baxter.com and let us know the nature of your request along with your contact information.