Prof II-Research and Development-R&D Engineer
Req #: 180001PX_en
Location: Bangalore, KA IN
Job Category: Research and Development
Date Posted: 1/23/2018 1:51:37 AM
Baxter provides a broad portfolio of essential renal and hospital products, including home, acute and in-center dialysis; 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.
You will be responsible for the overall technical direction and deliverables for these novel Renal products. Based on your significant technical expertise and leadership skills, you will also drive the full product development cycle from feasibility through lifecycle management. Assures that quality is built into the design during new product development. Proactively monitors the program and develops strategies to mitigate technical risks. Report out on the progress on a routine cadence to senior management.
Essential Duties and Responsibilities:
- As a System engineer, responsible for end to end development of the product, from capturing the user/marketing needs to final product release.
- Interact with customers and marketing to develop and refine user requirements.
- System engineer plays a critical role in product development, making sure the product meets all the functional and performance requirement. He/She is responsible to make sure the manufacturing and service requirements are translated into product design.
- Lead the development and documentation of the product systems architecture and systems level design, including the decomposition of the system architecture and requirements into subsystem and interface specifications.
- Develop the Risk Management Plan and execute the Risk Management activities defined by the plan.
- Develop and delivers the reliability goals of the product.
- Develop and deliver the regulatory compliance requirement in product design for intend country of use.
- Resolve competing constraints between interrelated functions (engineering, manufacturing, regulatory, marketing, etc.) required to deliver the product to market.
- Plan and execute system integration activities to minimize issues in systems verification and validation.
- Develop test plans, test protocols, and test reports for product integration testing.
- 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.
- 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
Education and/or Experience:
- Bachelors/Master’s Degree in Computer Science, Mechanical, Electrical, Biomedical Engineering or equivalent
- Minimum of 10 years’ experience in product development or related field, in the pharmaceutical and medical products industry.
- Familiarity with ISO, FDA and other regulatory standards
- Demonstrated experience working with vendors with different models of engagement.
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.