Job Description Summary

As a Senior Principal Systems Engineer, this individual is responsible for developing and maintaining the System Requirements and architecture for new products and is expected to collaborate with multiple disciplines that support the development of new products within our Advanced Patient Monitoring business.

In addition, this individual is expected to support system characterization, systems verification and validation planning and developing protocols if needed to test system functionality and requirements and reports documenting that effort. The role is expected to work cross-functionally with Quality, Regulatory, Marketing and Manufacturing as part of the new product development process at BD Advanded Patient Monitoring.

Job Description

We are the makers of possible 

 

BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities. 

 

We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you’ll be supported to learn, grow and become your best self. Become a maker of possible with us. 

Key Responsibilities:

• Works directly with marketing, field sales, and clinicians to define high level system requirements, product concepts, user interfaces, patient-contact parts and disposables, and interfaces to external systems and medical devices.Initiate and lead in the improvement, design and optimization of highly complex experiments and tests, analyze results, provide complex recommendations, and develop reports, based on engineering principles that translate to innovative products

• Generate work instructions, test methods, engineering models and drawings/prototypes, etc., to establish/characterize product and/or process specifications

• Oversee R&D support tasks; give instruction to technicians/engineers on conducting tests; train technicians/engineers and provide feedback; and coordinate technician/engineer work.

• May lead cross functional teams through complex design control activities including requirement specs, and risk documents with substantial knowledge on design control requirements

• Develop project plans to assess complex technology and drive project results

• Provide direction and guidance on strategies related to technical solution areas

• Proactively identify issues, achieve resolution, and resolve problems of highly significant complexity on designing parts, components and subsystems

• Train, coach, and guide lower level employees on more complex procedures

Basic Qualifications:

Required Education:

• Bachelor’s degree in Engineering (Mechanical ,Electrical, Biomedical, Software) or Scientific field & 8 + years of experience. – OR –

• Master's Degree or equivalent in Engineering or Scientific field & 7+ years of experience with test method development and writing test plans is required – OR –  

• Ph.D. or equivalent in Engineering or Scientific field & 4+ years of experience with test method development and writing test plans is required

Required Experience & Qualifications:

• Has previously worked in the medical device industry

• Statistical experience is required

• Has previous experience working with electromechanical instrumentation

• Experience writing system level requirements and working with different functional groups to decompose into hardware, software, usability and mechanical requirements

• Experience with writing and execution system verification and validation protocols.

• Strong understanding of IEC 6060-1 and relevant medical device standards 

Preferred Qualifications:

• Experience leading technical projects and/or teams through new product development phases to product launch

• Ability to adapt to change in a fast-paced environment

• Previous experience working with requirement man