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.
Becton, Dickinson Interventional (BDI) is a leading multinational developer, manufacturer and marketer of innovative, life-enhancing medical technologies in the fields of vascular, urology, oncology and surgical specialty products, employing over 65,000 people across 50 countries around the world. Founded more than 100 years ago, BDI pioneered many devices that are cornerstones of modern healthcare. BD - PI is the vascular division within BDI and focusses on interventional products for peripheral arterial disease (PAD), end stage renal disease (ESRD), and Cancer. We expect the highest levels of quality, integrity, service, and innovation from our employees - on the job and in the communities in which we work and live. In return, we foster an environment where individuals are treated with fairness, respect, and feel valued, acknowledged and rewarded. Be Your Best at BD-PI - and ultimately, you can have an impact on the lives of people around the world.
Responsibilities:
This position will assist with complaint investigations, quality management remediation efforts and other quality engineering activities as required.
Perform Product Complaint Investigations
Assist with Monthly Reporting Related to Post Market Surveillance
Assist with Engineering representation on Product Development Teams.
Initiate new or revised documentation
Lead cross-functional teams to develop risk assessment.
Develop physical and functional test methods to ensure specifications are met.
Write, review and approve design verification and validation protocols and reports.
Develop processes 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 on manufacturing processes.
Provide technical direction during design transfer activities.
Take part in training sessions, offering mentorship regarding department/division procedures and policies.
Coordinate and lead internal and supplier audits.
Develop and implement procedures to align with corporate and industry standards.
Understand and follow company procedures on regulatory requirements.
Provide support to the regulatory department in writing technical submissions.
Provide positive example and actively promotes compliance to all standards.
Maintain a professional working relationship with internal and external customer and support staff.
Prepare and present project updates and technical discussions.
Qualifications:
Ability to make and present engineering decisions
Strong interpersonal skills
Demonstrated Project Management skills
Advanced statistics
Understanding and application of DOE
Ability to lead cross functional teams
Engineering cost analysis
Ability to analyze and optimize manufacturing and quality systems
Advanced product, design & prototyping skills
Ability to create and provide training
Software application skills
Advanced problem solving skills
Ability to create, review and coordinate test protocols and reports
Ability to generate engineering proposals
Oral and written presentation skills
In-depth knowledge of regulatory requirements
Ability to develop and control a budget
Ability to manage technical personnel
Ability to perform design review functions
Must read, write and understand English
Must be detailed in handling information/data
Minimum Requirements:
Bachelors in Engineering or related field degree required.
Prefer a minimum of 0-2 years experience in the medical field or closely related industry or a Masters Degree.
Quality Engineering Certification (ASQ) or equivalent (preferred).
Knowledge of FDA GMP/GLP, Medical Device Directive, ASTM, AAMI, CEN and ISO.
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.
Why Join Us?
A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It's also a place where we help each other be great, we do what's right, we hold each other accountable, and learn and improve every day.
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 health. At BD, you'll discover a culture in which you can learn, grow, and thrive. And find satisfaction in doing your part to make the world a better place.
To learn more about BD visit https://bd.com/careers
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 protected status.
