Associate Staff Engineer, Product Development

Summary

The R&D team is seeking an exceptionally talented and passionate individual to help us identify and implement innovative solutions to address current and future health care needs in the Vascular Access markets. Within BD Medication Delivery Solutions (MDS) Research & Development, the associate in this position will be part of the Salt Lake City R&D team. Our R&D Engineers are responsible for developing and implementing new product designs, product improvements, and critical component changes for disposable and durable medical devices.

This position assists the R&D Engineering Teams in designing, developing, and implementing new products, processes, test methods and equipment. This position is also responsible for system development and improvement, along with managing projects with divisional impact.

• Consultant/Division expert;
  Division Technical expert.
• Develops innovative ideas for the organization.
• Broad business and technical understanding.
• Influences and directs others across the organization; coaches/mentors.
• Critical decision maker in areas of engineering and business needs.
• Leads new product development projects.
• Initiates new or revised documentation and tracks through appropriate approval cycles and implementation.
• Participates in and leads cross-functional teams and/or projects.
• Provides technical support on components, material methods, systems, processes, and/or equipment.
• Develops physical and functional test requirements to assure specifications and regulations are met.
• Writes and approves protocols, reports, and data.
• Manages testing outlined in protocols and test methods.
• Manages and develops validation studies on equipment and processes.
• Conducts and/or supports product complaint investigations.
• Understands and follows company procedures and regulatory requirements.
• Participates in and provides input to training on department and division procedures and policies.
• Manages project planning, budgeting, scheduling and tracking.
• Analyzes problems in design, process, and/or test development; recommends and implements solutions.
• Prepares and presents oral and written project updates and technical discussions.
• Develops and implements procedures and policies.
• Develops and implements manufacturing procedures.
• The duties and responsibilities are intended to be representative of the work performed by the incumbent(s) in this position and are not all-inclusive. The omission of a specific duty or responsibility will not preclude it from the position.

• Bachelor’s degree in STEM (Science, Technology, Engineering, Math)
• 6 years of engineering experience within the medical device or equivalent regulated industry.
• Experience having ownership of making and present engineering decisions.
• Experience managing multiple projects from initiation through closing phases (Determine and communicate project deliverables, develop a work breakdown structure and estimates, develop a viable schedule and management plans, Execute and control the project through closure)
• Experience training (creating, and critiquing training)
• Experience applying comparative statistics, as required.
• Extensive Software application skills.
• Experience creating, reviewing, and coordinating test protocols and reports.
• Experience generating engineering proposals.

• Master's degree in STEM with at least 4 years of engineering experience within the medical device or equivalent regulated industry.
• Experience with specific specialized engineering skills (Creating engineering cost analysis. Basic tooling design and drafting knowledge, Analyze and optimize existing processes and create new processes. Create, analyze, and optimize relevant manufacturing and quality systems.)
• Deep Knowledge in Material Science.
• Well versed in Bioengineering principles.
• Understanding of disciplined product development processes and quality requirements.
• Understanding and ability to design for high-volume manufacturing and/or durable electro/mechanical medical devices.
• Experience with specific tools and methods, such as statistical tools and Design of Experiments (DOE), computer analysis, and engineering fundamentals to support sound engineering judgment.
• Solid Works, Minitab, and FEA (Abaqus/Fluent) experience.
• Knowledge of regulatory and quality requirements (21 CFR 820.30).
• Understanding of failure theory and modes for plastics, elastomers, and metals due to static and time-variable loading conditions.
• Experience with clinical studies, human physiology, and simulated product use studies.
• Experience with contact and non-contact metrology.
• Knowledge of high-volume manufacturing and assembly processes, particularly those of plastic injection molding, metal stamping, and automated assembly techniques, including solvent bonding, adhesive bonding, ultrasonic welding, and interference-fitting.
• Experience with manufacturing process validation, including strategy development, First Article…