Senior R&D Engineer – Delivery System
April 10th, 2019
Primary Duties and Responsibilities:
TAVR Delivery System Projects’ Support:
- Develop Delivery System components and subsystems within defined R&D projects.
- Develop in-depth understanding of Delivery System and Valve interface requirements and test methodologies.
- Generate detailed component & subsystem designs, models and drawings using SolidWorks CAD Software; submit drawings for review/approval using HLT’s internal documentation control system.
- Develop effective R&D-stage manufacturing processes to produce prototype designs/parts; work with Manufacturing to transition R&D processes/designs to meet Validation/Qualification requirements.
- Provide inputs to timelines; risk assessments; progress/status of activities. Generate DHF deliverables per project Phase requirements. Support Critical Path
- Management activities
- Develop effective bench test methods; perform/delegate hands-on testing of sub-systems/systems as appropriate.
- Maintain rigorous work documentation during all project phases to support overall project requirements/deliverables and IP/Patent disclosures. Support generation of R&D test protocols & technical reports.
- Analyze test data using statistical tools; perform in-depth interpretation of results and generate detailed technical reports.
- Translate Customer Requirements into effective design concepts/solutions.
- Ensure work and product designs comply with Quality Management System (QMS) and Regulatory (FDA; CE, UL; ISO etc.) requirements.
- Design products to meet requirements regulated by FDA, UL, CE, and other governing bodies as defined by management.
- Participate in Preclinical study planning & execution.
- Support device development activities from concept to commercial launch.
- Interface directly with other functional groups – predominantly Quality and Manufacturing.
- Provide work direction to R&D technicians.
- Oversee and/or conduct training of new and existing employees and facilitate assimilation of new members and changes.
- Identify and promote/coordinate the acquisition of needed R&D equipment & supplies.
- Pursue continuing education and training consistent with company objectives.
Qualifications (Knowledge, Skills & Abilities):
- Bachelor of Science Degree in Engineering (Mechanical or Biomechanical).
- Minimum of 5 years medical device product development experience.
- Demonstrated proficiency with SolidWorks CAD modeling and engineering drawing generation.
- Hands-on experience developing/subcontracting “soft” rapid prototypes for initial engineering testing and screening.
- Demonstrated working knowledge of medical device delivery system technologies/processes including delivery catheter design and fabrication methods; guidewires; micro-machining; laser welding; single/multi lumen extrusions; polymers, metals, coatings; corrosion; adhesive bonding; sterilization processes; shelf life considerations.
- Fluent with Phase-driven Class III medical device product development cycles, requirements and deliverables.
- Demonstrated ability to develop product-driven bench test methods & to perform hands-on testing and test results interpretation.
- Strong interpersonal, communication, and technical writing skills.
- Experience with directing the work of technicians.
- Hands-on experience with Preclinical (animal studies) testing & analysis.
- Strong working knowledge of human & animal physiologies; particularly cardiology.
- Direct experience designing TAVR heart valve or other Class III implantable device delivery systems.
- Lead engineer experience for a complex Class III implantable device/system.
- 2+ years of experience managing or leading the work of technicians.
- Working knowledge of Cath Lab procedures & requirements.
- Travel requirements are moderate. Travel to facilities would be about 2 – 3 days duration each trip with total travel expected to be less than 10%.
If you are interested in applying for this position, please click this link: Sr. R&D Engineer – Delivery System