BD (Becton, Dickinson and Company) R&D Manager in New Hope, Minnesota
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 coordination of department and division activities during the product development process and management of assigned departmental personnel.
Coordinates and/or directs all aspects of product development activity related to a product line.
Coordinates product development activities of R&D/Product Development teams, including integration of RA, QA/QE, Operations, Clinical, Marketing, Sales and Packaging Engineering for a product line.
Participates as team leader or as an active member of the team to meet company objectives and ensure department responsibilities are completed.
Assesses priorities and makes assignments to direct reports to ensure project and company priorities are met.
Performs supervisory responsibilities for direct reports, including but not limited to, performance reviews, recommending salaries and promotions, training, interviewing and hiring decisions and disciplinary actions.
Identifies development needs and potentials of employees, and provides or recommends project assignments and training to increase expertise to meet current or future division needs.
Provides technical support and feedback for direct reports.
Coordinates with team members, internal and external suppliers and outside professionals to ensure project output meet users’ needs as well as applicable regulatory requirements.
Actively participates in training and providing input to training of employees on division procedures and policies.
Creates, tracks and meets project schedules, plans and budgets.
Reviews and analyzes costs in order to identify and implement cost improvements.
Provides input, feedback and maintenance for department and division procedures and policies.
Complies with company procedures and policies, government regulations.
B.S. degree in Manufacturing Engineering, Mechanical Engineering or other related engineering discipline, or equivalent experience
7 or more years of experience in R&D or process development
3 or more years of medical device or other regulated FDA/QSR and ISO environment
2 or more years of experience providing work direction to other engineers/technicians
Demonstrated knowledge of development, manufacturing and quality systems requirements for medical devices required
Experience with balloon catheters, stents and stent delivery systems preferred
Experience in process validation (IQ, OQ and PQ), including writing protocols and reports to support verification and validation activities for product commercialization
Experience in drug coating, active pharmaceutical ingredient handling, and working in controlled environment
Knowledge of cGMP and GLP is a plus.
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 and resources.#LI-NL1
While performing the duties of this job, the employee may be required to stand, walk, sit and use hands to manipulate tools, controls and office equipment. Work may involve continuous computer use with repetitive motion to wrists, hands and fingers. The employee frequently is required to see, talk and hear. The employee is occasionally required to bend, lift, reach or stoop. In addition, the employee must have visual acuity and color perception to conduct clean-room and laboratory duties. Employee must be able to wear personal protective equipment. Inability to meet one or more of these physical demands will not automatically disqualify a candidate or employee from the position. Upon request, the company may make reasonable accommodations.
While performing the duties of this job, the employee may work with chemicals and/or biological materials. The employee may be in an open cubicle environment and must be able to work in a team-oriented, fast-paced environment. Bard Lutonix is an affirmative action, equal opportunity employer that values and actively seeks diversity in the workforce.
This job description is intended as a summary of the primary responsibilities of and qualifications for this position. The job description is not intended as inclusive of all duties an individual in this position might be asked to perform or of all qualifications that may be required either now or in the future.
Industry Standard/Category: R&D Manager
Career Level: experienced
Relocation Available?: Yes
External Company Name: C.R. Bard, Inc.
External Company URL: www.crbard.com
C. R. Bard, Inc. (NYSE: BCR) 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 13,000 people around the world. Founded in 1907, we pioneered many devices that are now the cornerstones of modern healthcare.
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 and respect, and feel valued, acknowledged and rewarded. Bard is a M/F, Disabled and Vet EEO/AA Employer.
Be Your Best at Bard – and ultimately, you can have an impact on the lives of people around the world.