Principal Development Engineer

5 days ago


San Diego, California, United States Resonetics Full time
Job Summary:

As a Principal Development Engineer at Resonetics, you will be part of a cross-functional engineering team driving the design, development, verification, and manufacturing transfer of novel interventional medical devices. This role requires a strong background in medical device product design and development, with a minimum of 7 years of experience in the field. You will lead cross-functional teams in a technical environment, with a strong analytical and data-driven approach, and proven problem-solving abilities. Your excellent communication and presentation skills will enable you to effectively communicate with all levels within the organization. You will also have the ability to facilitate a collaborative working environment for customers and team members. Responsibilities:

• Summarize and refine product specifications
• Brainstorm novel therapeutic concepts
• Perform concept refinement and generate detailed CAD design
• Prototype and evaluate catheter-based designs
• Perform engineering calculations, including tolerance analysis
• Draft complex drawings with a demonstrated understanding of component manufacturing methods
• Develop in-vitro test methods, including fixture design and fabrication
• Perform in-vivo and in-vitro study protocol development, execution, reporting
• Develop manufacturing processes and documentation
• Create and maintain designs controls documentation
• Generate product risk analyses
• Lead customer meetings and communicate directly with clients in a timely and professional manner
• Participate in calls with prospective clients as a subject matter expert
• 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
• Exercise engineering leadership on internal and external meetings
• Drive conversations towards desired goals and outcomes in a respectful and professional manner
• Present and convey complex engineering concepts to internal and external stakeholders
• 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
• Display creative problem-solving skills
• Provide technical oversight to junior engineers and guide troubleshooting efforts
• Demonstrate deep technical expertise in specific technical and/or clinical areas
• Demonstrate superior productivity, independence, attention to detail, and self-motivation
• Work unsupervised, exercising independent judgment within primary job functions
• Demonstrate an understanding of all technologies and facilities across Resonetics
• Identify and explain opportunities for vertical integration to junior engineers and to clients
• Maintain a growth mindset by actively seeking and accepting constructive feedback
• Demonstrate an ability to adapt quickly and positively to changing priorities and processes
• Demonstrate an understanding of the common inspection techniques used in medical device design and manufacturing
• Incorporate Design for Metrology principles into their work
• Demonstrate an understanding of manufacturing priorities (efficiency, yield, line balancing)
• Routinely incorporate DFM and DFA principles when completing design tasks
• Enforce an NPI mindset in interactions with junior colleagues
• Demonstrate familiarity and compliance with Quality SOPs
• Has experience in all Product Development Process (PDP) phases sufficient to lead a project from Phase 0 through Phase 5
• Demonstrate strong time management and organizational skills
• Employ organizational tools to optimize personal performance
• Demonstrate functional application of advanced Solidworks skills
• Coach junior engineers through complex modeling tasks
• Draft complex drawings with a demonstrated understanding of component manufacturing methods
• Be proficient in GD&T
• Successfully contribute to multiple projects concurrently
• Assist junior team members with prioritization and time management
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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