Quality Engineer , Post Market Surveillance; PMS - Becton Dickinson

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 manufacturing and marketing—to look at the impossible and find transformative solutions that turn dreams into possibilities.

• Work with a team to meet the requirements in generating periodic PMS related reports
• Participate in projects to align with BD Quality, MDD/MDR strategies and regulatory submissions
• Identify gaps and maintain PMS processes in compliance with global regulations
• Participate in PMS planning and reporting
• Extract and generate PMS and operational performance data necessary for generating applicable reports
• Coordinate and provide oversight in the analysis of PMS data
• Identify and elevate instances when products are not achieving the intended performance based upon anticipated levels of frequency and/or severity
• Identify and evaluate new failure modes when encountered
• Maintain procedures, as necessary
• Support responding to requests for additional information from competent authorities, registries and notified bodies
• Work cross‑functionally with Quality, Regulatory, Clinical Affairs, and Operations departments to fulfill ad‑hoc data requests and deliver detailed analysis of PMS data
• Develop and maintain knowledge of support systems including Master Control, JDE
• Perform other related duties and responsibilities as assigned
• Ability to travel up to 5% of the time

• Apply project management tools to ensure reports are submitted based on the commitment timelines
• Ability to make and present risk‑based decisions
• Strong interpersonal skills
• Problem solving ability
• Ability to create, review, and coordinate reports based on established guidelines and regulatory requirements
• Oral and written presentation skills
• Ability to provide analysis within strict timeline requirements and assuming accountability toward delivering on agreed upon commitments

• Requires a minimum of a bachelor’s degree, engineering degree, or degree in a technical field
• Proficient in Windows OS and Microsoft Office Suite
• Proficient in Excel and data manipulation

• Medical device experience working with Class I, II, and III devices
• Experience in technical writing and project management
• Ability to develop and maintain dashboards using BI tools

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.

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. On occasion the employee may work in a preclinical setting like an animal lab, cadaver lab or attend clinical case observations.

BD prioritizes 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.

Primary

Work Location:

USA AZ - Tempe Headquarters

Work Shift:

Pando Logic.

Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to 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, and other legally protected characteristics.