Quality Engineer II

We are the people who give possibilities purpose

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 Med Tech products per year-to look at the impossible and find transformative solutions that turn dreams into possibilities.

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 Med Tech 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.

Responsibilities:

* Leads development of risk assessments and test methods

* Supports component qualifications, design validation / verification and process validation

* Leads basic level 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

* Quality Engineering representation on Product Development Teams.

* Participate and provide guidance to training on department/division procedures, and policies.

* Participate in project planning, budgeting, scheduling and tracking.

* Support internal and external supplier audits.

* Develop and implement procedures to align with corporate and industry standards.

* Provide support to the regulatory department in writing technical submissions.

* Provide positive example and actively promote compliance to division, corporate and industry standards.

* Maintain a professional working relationship with internal and external customer and support staff.

* Prepare and present project updates and technical discussions.

* Support "Voice of the Customer" identification and translation into design inputs.

* Knows how products are used and impact the user(s) so that risk can be handled optimally.

* Apply Quality Engineering tools (Sampling Plans, Root Cause Analysis, Statistics, etc…)

* Support remediation and regulatory requirements including MDSAP/EUMDR.

Requirements:

* Bachelor degree in STEM (Science, Technology, Engineering, Math) with a minimum of two (2) years of engineering experience within the medical device or equivalent regulated industry OR,

* Master's degree in STEM and engineering experience within the medical device or equivalent regulated industry.

* Solid understanding in some of the related business technologies.

* Ability to develop solutions with moderate business impact.

* Sophisticated statistical and risk assessment techniques.

* Confirmed understanding 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 social skills

* Ability to analyze and optimize manufacturing and quality systems

* Product, design & prototyping

* Ability to create and provide training

* Software application skills

* 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 multi-functional teams

* Understanding of regulatory requirements

* Ability to lead creation of risk management files

* Ability to translate Voice of the Customer to Design Requirements and then to Manufacturing control plans

* Quality Engineering Certification (ASQ) or equivalent.

* Solid understanding of FDA GMP/GLP, Medical Device Directive, ASTM, AAMI, CEN and ISO

At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective…