Job Description Summary

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. 

This Systems Engineer translates voice of customer and stakeholder needs into system and product requirements, identifies potential hazards, and assesses requirements to ensure that the product meets the user/business needs, develops design and process specifications for new hardware and software products, aids in product verification and validation, and provides support in sustaining activities. The expectation for a Senior Systems Engineer is that they regularly serve on smaller project core teams, act as a leader of technical excellence, and participate as an agent for continuous improvement within the Systems Engineering function. As such they are expected to help identify tasks/resources to ensure that critical project landmarks are met, and systems integration activities are identified and fulfilled.

A Senior Compliance and Systems Engineer in this role is responsible for using their broad technical expertise, leadership skills, and product development knowledge to provide Systems Engineering and Compliance support through different phases of product life cycle.

Essential Functions:

• Working knowledge of product development lifecycle, concept through launch

• Leads system/product-level feasibility and risks assessments

• Provide compliance support throughout the product life cycle on product project teams (e.g. developing regulatory and compliance strategies, compliance assessments, work with NRTLs)

• Facilitates multi-functional knowledge and experiences to promote the understanding and resolution of in-market and product development issues

• Responsible for coordination of system-level product development and its integration

• Serves as a resource to examine system behavior issues and bring to resolution for on-market products

• Sees opportunities and drives continuous improvement efforts

• Applies DFSS standard methodologies on all projects.

Requirements/Qualifications:

• Must have a Bachelor’s degree in Science or Engineering (Electrical degree preferred). A post graduate degree is preferred.

• At least 5 years related work experience of skills/attributes listed below with medical device in Systems Engineering or Compliance Support (combination of work experience and advanced degrees)

Skills/Attributes:

• Experience with Systems Engineering and requirements management.

• Familiar with systems integration and testing, system architectural planning and design, Reliability Engineering, Project Management, and Failure Modes Effects Analysis.

• DFSS knowledge and experience or statistical test design and analysis knowledge or Critical Parameter Management.

• Knowledge of global medical device regulations

• Performed regulatory compliance assessments for US and International markets

• Ability to work independently and as a member of a team.

• Ability to lead multi-discipline engineering teams.

• A strong technical background within Systems Engineering, medical device development, or similar

• Excellent communication skills with the following departments: interdepartmental (with fellow engineers), multi-functional (with Marketing, Clinical Representatives, Software Engineers, Test Engineers, and Quality Engineers)

• Must have strong writing skills.

• Find opportunities for continuous improvement projects/efforts.

Nice to have: 

• Good understanding of Basic Safety and EMC Standards e.g. 60601-1, 61010-1, 60601-1-2 

• Good understanding of ISO 15223-1 and ISO 20417 

• Quality Management System in SAP 

• Team Foundation Server

At BD, we prioritize on-site collaboration because we believe it fosters