BD (Becton, Dickinson and Company) Sr. R&D Engineer in New Hope, Minnesota
Job ID: 2018-11634
Career Level: experienced
Division: New Hope, MN / Lutonix
Location: New Hope,Minnesota,United States
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.
Additional Desirable Qualifications Skills and Knowledge:
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
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