BD (Becton, Dickinson and Company) Sr. R&D Engineer in New Hope, Minnesota
Job ID: 2018-11634
Career Level: experienced
Location: New Hope,Minnesota,United States
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.
Summary of Position with General Responsibilities:
The Sr. R&D Engineer works cross-functionally to lead research and development efforts of complex technologies on drug eluting medical devices. The position focuses on drug coating development and processing including; project planning, innovative catheter and coating designs, prototype development, testing, characterization, analysis and reporting.
Essential job Functions:
Research and develop drug coating formulations, coating processes and coating equipment.
Apply technical knowledge to innovate, design and develop processes, procedures, tooling and or automation.
Ensure process capabilities, prioritizing process improvement opportunities and implementing chosen improvements.
Execute New Product Development (NPD) deliverables working collaboratively with cross-functional team members.
Plan, organize and conduct all aspects of technical reviews for assigned projects.
Ensure proper documentation is complete and meets quality system requirements.
Write and review product development plans, design reviews, validation protocols and reports.
Oversee development builds associated with assigned projects.
Provide Design for Manufacturability (DFM) input for the engineering print package.
Contribute ideas and/or generate intellectual property submissions.
Education: B.S. degree in Manufacturing Engineering, Mechanical Engineering or other related engineering discipline, or equivalent experience.
Experience: 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.
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
Statistical analysis of data, pareto analysis, and other investigational tools
Demonstrated hands-on technical aptitude
Ability to travel to audit and/or transfer products to manufacturing partners
Excellent oral and written communication skills
Knowledge of cGMP and GLP
Knowledge of US FDA QSR and ISO 13485 requirements for design controls
Education and/or Experience:
While performing the duties of this job, the employee is regularly required to stand, walk, sit and use hands to manipulate, handle or feel objects, tools, controls and office equipment. The employee frequently is required to talk and hear. The employee is occasionally required to reach with hands and arms and stoop, kneel or crouch.
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. Bard Lutonix is an affirmative action, equal opportunity employer that values and actively seeks diversity in the workforce.
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