Quality Engineer I, Post Market Surveillance (PMS)
In-Office, Tempe, AZ
- Job ID
- R-542728
- Category
- Engineering
- Location
- Tempe, Arizona
Build an engineering career where innovation, ownership and impact move healthcare forward
At BD, Engineering and R&D professionals design, develop and improve the technologies that shape how healthcare is delivered worldwide. You'll apply scientific thinking, technical expertise and creative problem-solving to turn complex challenges into solutions that matter.
Whether you specialize in mechanical, electrical, process, systems, software or research engineering, BD offers the scale, resources and freedom to innovate – with clear expectations, accountability for outcomes and opportunities to grow your career alongside industry-leading technology.
And as one of the world's largest medical technology companies, you'll shape solutions that reach across global healthcare systems and improve lives at scale.
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 MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.
Job Description
RESPONSIBILITIES
Responsibilities include, however are not limited to:
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 escalate 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
Performs other related duties and responsibilities as assigned
Ability to travel up to 5% of the time
QUALIFICATIONS
Required Qualifications
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
Education and/or Experience
Requires a minimum of a bachelor’s degree, Engineering Degree, or degree in a technical field
Proficient in Windows OS, Microsoft Office Suite
Proficient in Excel in manipulation of data
Preferred Knowledge and Skills
Medical device experience working with Class l, ll, and lll devices
Experience in technical writing and project management
Ability to develop & maintain dashboards using BI tools
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 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.
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.
#CLOLI
Why Join Us?
To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of healthcare. At BD, you’ll discover a culture in which you can learn, grow and thrive.
We believe that when people connect in person, we learn faster, collaborate more deeply, and build a stronger culture. Join us and enjoy a culture where face-to-face collaboration supports your learning, your progress, and your success.
To learn more about BD visithttps://bd.com/careers.
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.
Required Skills
Optional Skills
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Primary Work Location
USA AZ - Tempe HeadquartersAdditional Locations
Work Shift
Success Profile
What sets successful Engineering and R&D professionals apart? You're likely to thrive if you are:
- Analytical
- Collaborative
- Curious
- Detail-oriented
- Inventive
- Problem-solver
Ready for your next challenge?
This is an environment for engineers who want to think boldly and execute with precision. You'll have the opportunity to influence design decisions, contribute across the full product lifecycle and see how your work moves from concept to real-world impact – backed by the scale of a global MedTech leader.
Hear from one of our BD Innovators about how BD uses cutting-edge AI and machine learning to power decisions that improve patient outcomes and expand access to care. This is where your work drives real-time impact across the globe.
Hear from Our Associates
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"BD is a big, global company so don't be afraid to connect with and reach out to others. There is so much to learn here, and the company does an amazing job of helping people develop and grow. I'd also offer to become like a sponge and soak up as much knowledge as you can and put your Career Blueprint to work for you. I really love my job and am so grateful to work at BD."
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"I think we have something like more than 30 different countries represented by those working within the Research Centre Ireland, which is impressive and one of my favourite things about BD. I work with electrical, mechanical engineers, scientists and so many others – it's wonderful to see and hear so many different perspectives during the day."
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"I continue to be amazed at how we keep innovating in the Med Tech space. We constantly evaluate how to bring even more solutions to healthcare professionals, how to increase the efficiency of our technologies, all while keeping the patient impact in mind. Not only have I found meaningful work at BD, but a place where I feel I can thrive."
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"During my interview, I learned how much of an impact our infusion solutions have across the world and I was impressed because whether it's analgesics, cancer treatments, anesthesia or other treatments, the likelihood of someone within your own family using our product is high. Contributing to the creation of products that have the ability to make such a big impact in healthcare is a great feeling. I love my role at BD."
Benefits
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Competitive Compensation
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Retirement Plans
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Healthcare Coverage
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Paid Time Off
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Parental Leave
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Employee Assistance Program
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Rewards & Recognition
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