Baxter International Inc. develops, manufactures and markets products that save and sustain the lives of people with hemophilia, immune disorders, infectious diseases, kidney disease, trauma, and other chronic and acute medical conditions. As a global, diversified healthcare company, Baxter applies a unique combination of expertise in medical devices, pharmaceuticals and biotechnology to create products that advance patient care worldwide.The Senior Principal Quality Engineer (Embedded Software) works as a member of one or more project teams engaged in new product development and/or product sustaining related to embedded software development for medical device systems. Serving as a quality representative on the software project team and working closely with the Core Team Leader, this individual is responsible for ensuring each project is developed and released meeting customer expectations and regulatory requirements related to embedded software. He or she will work closely with product engineering to ensure successful design, development, testing and transfer and provides support to sustaining engineering.
Bachelor?s degree in Engineering or Computer Science required, plus 6-8 years of experience in an FDA regulated industry with a thorough understanding of FDA QSR, associated guidance and ISO standards for medical devices, embedded software and quality management systems. Knowledge/experience required:
- Design and Development Planning
- Development of Technical Requirements and Product Specifications
- Risk Management / FMEA
- Design Verification and Design Validation
- Statistical Analysis
- Design Reviews
- Design Transfer Activities
- Design History File Management
Candidate must have:
- Track record of getting embedded medical device software systems released to market
- Familiarity with, and certification in ASQ, Six Sigma, LEAN manufacturing or other vigorous quality control programs desirable; ASQ CSQE preferred
- Solid understanding of FDA regulations and ISO standards, especially in the areas of design control and design change control.
- Experience with FDA inspections and ISO/Notified Body audits is a plus
- Ability to work at Senior Management levels
- Strong communication and leadership skills.
- Strong, results driven, project management skills.
- Detailed knowledge of embedded software development, quality assurance and verification and validation testing
- In-depth understanding of software development lifecycles
- Excellent presentation skills
- Excellent problem solving skills
- Ability to teach quality concepts to others
Baxter provides its employees with comprehensive compensation and benefits.To view other opportunities at Baxter and to learn more about the company, please visit our Web site at http://www.baxter.com/about_baxter/careers . EOE M/F/D/V.
