Principal Development Engineer

1 day ago


San Diego, California, United States Resonetics Full time
Job Title: Principal Development Engineer

Resonetics is seeking a highly skilled Principal Development Engineer to join our team. As a key member of our cross-functional engineering team, you will be responsible for driving the design, development, verification, and manufacturing transfer of novel interventional medical devices.

Responsibilities:
  • Summarize and refine product specifications to ensure accuracy and feasibility.
  • Brainstorm novel therapeutic concepts and develop detailed CAD designs.
  • Prototype and evaluate catheter-based designs, performing engineering calculations and tolerance analysis as needed.
  • Draft complex drawings with a demonstrated understanding of component manufacturing methods.
  • Develop in-vitro test methods, including fixture design and fabrication, and perform in-vivo and in-vitro study protocol development, execution, and reporting.
  • Develop manufacturing processes and documentation, creating and maintaining design controls documentation.
  • Generate product risk analyses and lead customer meetings, communicating directly with clients in a timely and professional manner.
  • Participate in calls with prospective clients as a subject matter expert and author multi-phase/PDP proposals and project timelines with little guidance.
  • Take responsibility for the education and training of more junior engineers through the course of their own project work, may formally mentor one or more junior engineers, and foster a culture of learning.
  • Exercise engineering leadership on internal and external meetings, driving conversations towards desired goals and outcomes in a respectful and professional manner.
  • Present and convey complex engineering concepts to internal and external stakeholders, using situational awareness to optimize timeliness of communication and communication style.
  • Identify and report unmet customer needs applicable to Resonetics technology to the Advanced Technology Group.
  • Possess broad experience with process development techniques used in the assembly of catheter-based devices, troubleshoot and optimize complex processes in an efficient and reliable manner.
  • Execute on broadly defined technical challenges/high-level requests, defining specific direction for themselves and team members to achieve the desired outcome.
Qualifications:
  • A minimum of 7 years experience in medical device product design and development.
  • Strong project management experience leading cross-functional teams in a technical environment.
  • Strong analytical and data-driven approach with proven problem-solving abilities.
  • Strong presentation, written, and verbal skills, ability to communicate with all levels within the organization.
  • Solid team leadership, team building, and facilitation skills.
  • Demonstrated mediation skills and ability to resolve apparently conflicting requirements through effective communication.
  • Ability to facilitate a collaborative working environment for customers and team members.
  • Comfort communicating and/or presenting in front of clients and large project teams.
  • Ability and willingness to travel.
  • Close familiarity with FDA QSR and ISO 13485 medical device regulations.
  • Experience in all phases of the medical device product development lifecycle.
Compensation:

Pay Range: $125,000-145,000



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