Principle Risk Engineer
Req #: 180003KL_en
Location: Bangalore, KA IN
Job Category: Engineering
Date Posted: 2/19/2018 6:49:15 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.
Manage a diverse preclinical team to support global drug and device safety evaluation. Utilizes solid understanding of theories and practices of a variety of preclinical disciplines to manage complex projects or programs within boundaries of quality, time and budget. Based on significant toxicology expertise, design, review and/or approve complex study design concepts or toxicology assessments and provides general direction to staff.
- Apply a deep understanding of standards and practices in Risk Management and toward the development of new or existing products or processes.
- Support teams in the development/maintenance of Product Risk Management deliverables for specific products.
- Plan, schedule, and lead project assignments using appropriate engineering techniques, processes, and methods with minimal guidance.
- Identify and define risk and reliability related requirements from applicable product standards (collateral and particular).
- Provide guidance to design teams in Risk process execution using relevant methodologies, tools, and techniques.
- Collaborate with cross-functional resources (e.g. hardware, clinical, human factors, etc.) involved in Risk Management process activities.
- Support sustaining teams in Risk analysis and estimation as part of Post Market events and Investigations.
- Deep experience/expertise in Risk Management, particularly in the Medical Device space.
- Minimum 4-6 years of hands-on experience in Product Design, and fluent in full life-cycle product development methods/activities.
- Possess strong engineering knowledge and experience in electromechanical disciplines and design principles, preferably Electro-Mechanical Medical Devices (e.g., Dialysis Machines).
- Thorough knowledge of US and International Medical Device regulations and standards related to Design Control and Risk Management: (e.g., ISO 13485, ISO 14971, IEC 60812, IEC 61025, IEC 62366, IEC 60601, etc.).
- Demonstrated experience and familiarity hazard and failure analysis deliverables (Hazards Analysis, FMEAs, FTAs, etc.).
- Expertise and fluency in Excel, DOORs, TCU, and/or other Requirements Management & Risk tools.
- Understanding of statistical techniques required for developing predictive risk models and deliverables, and for performing Risk assessments from field Complaint data.
- Strong critical thinking skills.
- Requires strong organization and polished communication skills, with the ability to interface with both technical and non-technical personnel.
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.