Job Description Summary

This position supports product leadership and risk management of new product development and sustaining activities. Additionally, this position may have direct reports as needed.

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. 

Job Responsibilities: (Primary Duties, Roles, and/or Authorities)

• Technical leadership skills including an understanding of medical device operations (e.g., medical device manufacturing, process development, quality assurance)

• Leads development of risk assessments and test methods

• Leads component qualifications, design validation / verification and process validation

• Leads product investigations

• Ability to make and present risked based decisions

• Assess product changes against product design

• Supports translation of design inputs into manufacturing control plans

• Develop and implement procedures to comply with corporate and industry standards.

• Coordinates and/or directs all aspects of product development activity related to a product line

• Leads development of risk assessments and test methods

• Quality engineering representation on Product Development Teams

• Prepare and present project updates and technical discussions

• Participate in project planning, budgeting, scheduling, and tracking

• Support internal and external supplier audits

• Provide support to the regulatory department in writing technical submissions

• Complies with company procedures and policies, government regulations

• Ability to travel for business, project, and issues approximately up to 25% of time

• Other duties and projects, as assigned

Education and Experience:

• BS in Engineering

• Minimum of two years’ experience in engineering or Quality engineering experience within the medical device, pharmaceutical, or equivalent industry

Knowledge and Skills:

Required Qualifications:

• Knows how products are used and impact the user(s) so that risk can be managed effectively

• Apply Quality Engineering tools (Sampling Plans, Root Cause Analysis, Statistics, etc.)

• Ability to lead creation of risk management files

• Ability to develop solutions with business impact

• Advanced statistical and risk assessment techniques

• Working knowledge of test method (development and validation), equipment qualifications, process and design validation, risk assessment techniques, and component qualification methodologies

• Ability to make and present risk-based decisions

• Strong interpersonal skills

• Ability to analyze and optimize manufacturing and quality systems

• Product, design & prototyping

• Ability to create and provide training

• Problem solving ability

• Ability to create, review and coordinate test protocols and reports

• Ability to generate engineering proposals

• Oral and written presentation skills

• Ability to Lead cross functional teams

• Understanding of regulatory requirements including ISO 13485, ISO 14971          

Preferred Qualifications:

• Quality Engineering Certification (ASQ) or equivalent

Physical Demands:

While performing the duties of this job, the employee is regularly required to stand, walk, sit, use sight, and use hands to manipulate, handle or feel objects, tools, controls, and office equipment. The employee frequently is required to verbally communicate with other associates. The employee is occasionally required to reach with hands and arms and stoop, kneel or crouch.

Work Environment:

While performing the duties of this job, the employee may be in an open cubicle environment.  Candidate must be able