Job Description Summary

Be part of something bigger!
BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. We have over 65,000 employees and a presence in virtually every country around the world to address some of the most challenging global health issues.

Job Description

Our vision for “MMS” at BD

 With our technical capabilities, the Medication Management Solutions (MMS) team are able to manage multiple systems and our operational capabilities enable us to have medications available when and where needed, reducing inefficiency and waste for nursing and pharmacy teams.

About the role

You will be involved in R&D projects for New Product Introduction and Product maintenance (mechanical, electrical, software design….) and will interact with key functions across BD Worldwide organization (R&D, Operations, Reg Affairs, Marketing, Medical Affairs) and external projects partners (key suppliers, contract labs, CMOs).

Main Responsibilities will include:

Manage the relationship with 3rd party testing and certification providers

• Own the compliance plan
• Answers question from the providers during certification exercises.
• Obtain product certification for approvals to sell products in the global marketplace.

Ensure standards are correctly interpreted and applied during design verification activities by:

• Ensuring test procedures or protocols are aligned or are updated accordingly

Increase organization knowledge

• Creates guidance to drive harmonization across the organization
• Serves as SME and trains associates
• Updates job knowledge by tracking and understanding emerging compliance engineering practices and standards; participating in educational opportunities and professional organizations; reading professional publications; maintaining personal networks
• Support investigation for Issues related to product design
• Provide support to internal and regulatory body audits and associated corrective actions.

• Engineer with a experience in Quality Management
• 6+ years industry experience (Healthcare/Pharmaceutical/Biologics/Medical Devices)
• Project experience
• Experience working with cross-functional teams and remote teams, promote work in multidisciplinary teams
• General understanding of Design Control, FMEA/Risk Management
• Understanding of industry regulations/standards:  ISO 13485, QSR, 21CFR820, ISO 60601, 62304, 62336
• Rigor and good organization
• Ability to act as Change Agent and effectively manage change
• Strong interpersonal skills : Demonstrate strong and clear accountability for successful and timely completion of tasks
• Influence: Intuitively and quickly assess people and situations and act accordingly. Demonstrate persuasion and timing skills.
• Prefer infusion pump experience or drug delivery experience (regulated FDA industry)