JOB DESCRIPTION SUMMARY

This position will support development of new products and processes for medical devices within the Research and Development department and support transfer of the developed processes and products into Operations. The position provides leadership and facilitation of Quality System activities associated with internal Bard design control procedures, 21 CFR 820 and 803, ISO 9001-13485, and MDD and MDR.

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.

REQUIRED QUALIFICATIONS:

• Working knowledge of design controls, FDA GMP/GLP, Medical Device Directive, and ISO
• Ability to work on cross functional teams
• Ability to make and present quality engineering decisions
• Strong interpersonal and writing skills
• Ability to create, review and coordinate test protocols and reports
• Experience in comparative statistics and design of experiments
• Ability to analyze and optimize manufacturing and quality systems
• Basic product design & prototyping skills
• Ability to create and provide training
• Software application skills including Word, Visio, Excel, Powerpoint and Minitab or equivalent software
• Problem solving ability
• Strong oral and written presentation skills
• Ability to interpret Federal Regulations and Corporate, Business Unit and Department Procedures
• Strong oral and written communication skills in English
• Must be detailed in handling of information/data
• Ability to effectively present information in one-on-one and group situations to supervisor, management, and other employees of the organization
• Ability to present Corporate, Business Unit and affiliates in a professional manner
• Ability to work in areas that contain radioactive material

PREFERRED QUALIFICATIONS:

• Advanced statistics and/or 6 Sigma green belt certification is desirable

EDUCATION AND/OR EXPERIENCE:

• A minimum of a BS in a scientific discipline (Engineering, Engineering Technology, Chemical/Biological or equivalent)
• 4 years experience in the medical field or closely related industry.
• Demonstrated knowledge and experience in design controls, validations and qualification protocol generation, execution and reporting
• ASQ certification (e.g. CQE, CQA, etc.) preferred
• Proficiency in Microsoft Word and Excel
• Basic applied statistics and design of experiments

WORK ENVIRONMENT:

While performing the duties of this job, the employee may be in an open cubicle environment. Candidate must be able to work in a team-oriented, fast-paced environment. BD is an affirmative action, equal opportunity employer that values and actively seeks diversity in the workforce.
This job description is intended as a summary of the primary responsibilities of and qualifications for this position. The job description is not intended as inclusive of all duties an individual in this position might be asked to perform or of all qualifications that may be required either now or in the future.
At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting.
For certain roles at BD, employment is contingent upon the Company’s receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD’s Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.

• Provide Quality Engineering representation on Product Development Teams
• Participate in design of experiment (DOE) activities to evaluate developed processes
• Develop and validate physical and functional test methods to ensure specifications are met
• Write, review and/or assist in performance of design verification and validation protocols and reports
• Develop process validation requirements (IQ, OQ, PQ) and equipment qualifications
• Conduct and /or coordinate testing outlined in protocols and test methods
• Perform process improvement, control and monitoring of manufacturing processes
• Initiate/review new/revised Quality System documentation and track through approval cycles and implementation
• Participate on cross-functional teams to develop risk assessments and failure mode analyses
• Provide technical direction during design transfer activities
• Participate in and provide input to training on BPV department/business unit procedures and policies
• Identify, implement, and monitor procedures and systems to support 21CFR§820, ISO 13485, and the European Medical Device Directive
• Understand and follow company procedures on regulatory requirements
• Provide positive example and actively promote compliance to all standards
• Maintain a professional working relationship with internal and external customers and support staff
• Participate in project planning, budgeting, scheduling, and tracking
• Participate in internal and supplier audits
• Conduct complaint investigations
• Develop and implement procedures to provide easy to follow instructions
• Prepare and present project updates and technical discussions
• Travel as required by the above duties and responsibilities. Travel generally <25% but will be greater during the first year of service as needed for training purposes
• Other duties as assigned
• Understand and follow the established corporate safety standards, local facility operating procedures and safety policies
• Follow Quality Systems Regulations and established procedures.