Job Description Summary
The main responsibilities of the position are to provide
strategic vision and tactical implementation of the quality
engineering role in support of new product development and
sustaining projects for the V Mueller platform within the Surgery
business unit. The position will represent the QA team as a
spokesperson and leader within NPD. Surgery has a wide range of
surgical instruments and technologies, and the leader must be able
to adapt their quality assurance skill set and apply it to a
breadth of difficult technical issues. The position requires
strategic vision in building the organization's skill sets and
capabilities, as well as adapting the QMS to meet the constantly
evolving needs of the business. The leader must have the ability to
influence internally and externally, including the quality
engineering staff, functional peers, senior leaders, and suppliers.
The incumbent will work closely with R&D, Manufacturing,
Marketing and Regulatory Affairs, to collaborate on complex issues
and apply critical thinking to each outstanding situation.
Essential Duties and Position Responsibilities:
* Creation of design inputs.
* Evaluation and approval of new product designs, specifications
and product test procedures.
* Evaluation of HF&U activities, including Formative and
* Designing and executing statistical engineering experiments to
compare design alternatives, compare proposed product with
competitive products and evaluate performance.
* Co-ordination of biocompatibility testing on all new
* Development of test methods and test method validations for
the adequate evaluation of designs.
* Development and execution of Design Verification plans.
* Development and coordination of Risk Management activities,
* Development of accelerated and real time shelf life plans.
* Development of supplier and component qualification plans in
support of NPD projects.
* Providing the smooth transition of new products to
manufacturing through the continuous review of all quality systems,
inspection data and product yields.
* Developing process and product controls to assure the
consistent manufacturing of products to established
* Development of processes and equipment validation plans.
* Support failure investigation process to identify root cause
of product, process, and system non-conformances in order to drive
continuous improvement as well as corrective and preventive
* Develop and improve quality systems to facilitate business and
quality objectives and compliance review and resolution process to
ensure the organization is alerted to issues in time to resolve
potential adverse effects on the customer, company, or
* Collaborate with the Sr. Director, Quality Assurance
Qualifications, Knowledge, and Skills Required:
* Bachelor Degree in Engineering or Technical Science required;
Master's Degree strongly preferred.
* Minimum of 3 years' experience managing senior level quality
engineers and/or a Platform team in an Engineering environment.
* Minimum of 4 years' experience in a product development
* Minimum of 3 years' experience in the medical device
* Formal course work in Statistical Quality Control.
* Ability to apply broad technical, business, and compliance
knowledge to improve business results.
* Ability to effectively negotiate and influence senior leaders,
other departments, and industry.
* Conceptual and practical knowledge of applicable processes,
systems and validation processes and systems.
* Ability to adjust to and assimilate new technologies and
* Effective communication skills.
* Effective problem-solving techniques.
* Demonstrated servant leadership skills.
* Ability to travel up to 20%. Remote opportunity will be
Becton, Dickinson and Company is an Equal
Opportunity/Affirmative Action Employer. We do not unlawfully
discriminate on the basis of race, color, religion, age, sex,
creed, national origin, ancestry, citizenship status, marital or
domestic or civil union status, familial status, affectional or
sexual orientation, gender identity or expression, genetics,
disability, military eligibility or veteran status, or any other
At BD, furthering Inclusion and Diversity is not just the right
thing to do-it is both a cultural priority and a strategic
imperative. One of the many reasons people choose to work at BD is
for our comprehensive Total Rewards program aimed at the varying
needs of our diverse and global associates. Total Rewards at BD
includes base pay, incentives and benefits that support your health
and wellness, family, money and lifestyle.
We will ensure that individuals with disabilities are provided
reasonable accommodation to participate in the job application or
interview process, to perform essential job functions, and to
receive other benefits and privileges of employment. Please contact
us to request accommodation.
Primary Work Location
USA IL - Vernon Hills