BD (Becton, Dickinson and Company) R&D Project Manager in New Hope, Minnesota
Job Description Summary
BD is a global medical technology company that is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. We lead in patient and healthcare worker safety, and technologies that enable medical research and clinical laboratories. Our innovative solutions help advance medical research and genomics, enhance the diagnosis of infectious disease and cancer, improve medication management, promote infection prevention, equip surgical and interventional procedures, optimize respiratory care and support the management of diabetes.
Our Minneapolis location, Lutonix, is a design center focused on the advancement and continuous success of Lutonix Drug Coated Balloon, one of BD’s prized Peripheral Intervention products. Our culture is a natural home for driven, strategic and proactive people who want to follow our motto of Trailblazing Innovation for Patients . Lutonix utilizes collaborative, cross functional teams that operate globally; our team is committed to making a difference in patients’ lives around the world. This is a place you can find a career with meaningful purpose – advancing the world of health through your successes.
The individual in this position is responsible for the execution and coordination of project activities during the product development process and may include management of assigned departmental personnel.
Essential Job Functions
Coordinates and/or executes all aspects of product development activity related to a product line
Coordinate and execute project deliverables working collaboratively with cross-functional team(s)
Creates, tracks and meets project schedules, plans and budgets.
Coordinates with team members, internal and external suppliers and outside professionals to ensure project output meet users’ needs as well as applicable regulatory requirements
Plan, organize and conduct all aspects of technical reviews for assigned projects
Write and review product development plans, design reviews, validation protocols and reports
Apply technical knowledge to innovate, design and develop processes, tooling and/or automation
Contribute ideas and/or generate intellectual property submissions
Provides technical support and feedback for any direct reports
B.S. degree in Bio-Medical Engineering, Mechanical Engineering or other related engineering discipline
Minimum 7 years of experience in R&D or process development, with a minimum of 5 years of medical device experience or another highly regulated FDA/QSR and ISO environment
Minimum 3 years of program/project management in medical device or other regulated FDA/QSR and ISO environment
Minimum 2 or more years of experience providing work direction to other R&D personnel
Demonstrated knowledge of development, manufacturing and quality systems requirements for medical devices
Experience in process validation (IQ, OQ and PQ), including writing protocols and reports to support verification and validation activities for product commercialization
Experience with balloon catheters, stents and stent delivery systems preferred
Experience in active pharmaceutical ingredient handling and working in controlled environment
Experience with combination medical devices including regulatory approval requirements
US FDA QSR and ISO 13485 requirements for design controls
Strong skills in communicating with all levels of technical and operating management
Demonstrated positive communication and human relation skills
Strong ability to analyze and use technical data via statistical and pareto analyses and other investigational tools
Primary Work LocationUSA MN - New Hope
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