Part of a cross-functional engineering team driving the design, development, verification, and manufacturing transfer of novel interventional medical devices.

• Summarizes and refines product specifications.
• Brainstorms novel therapeutic concepts.
• Performs concept refinement and generates detailed CAD design.
• Prototypes and evaluates catheter-based designs.
• Performs engineering calculations, including tolerance analysis.
• Drafts complex drawings with a demonstrated understanding of component manufacturing methods.
• Develops in-vitro test methods, including fixture design and fabrication.
• Performs in-vivo and in-vitro study protocol development, execution, reporting.
• Develops manufacturing processes and documentation.
• Creates and maintains designs controls documentation.
• Generates product risk analyses.
• Leads customer meetings. Communicates directly with clients in a timely and professional manner.
• Participates in calls with prospective clients as a subject matter expert.
• Authors multi-phase/PDP proposals and project timelines with little guidance.
• Takes 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.  Fosters a culture of learning.
• Exercises engineering leadership on internal and external meetings. Drives conversations towards desired goals and outcomes in a respectful and professional manner.
• Presents and conveys complex engineering concepts to internal and external stakeholders. Uses situational awareness to optimize timeliness of communication and communication style.
• Identifies and reports unmet customer needs applicable to Resonetics technology to the Advanced Technology Group
• Possesses broad experience with process development techniques used in the assembly of catheter-based devices. Troubleshoots and optimizes complex processes in an efficient and reliable manner.
• Executes on broadly defined technical challenges/high level requests, defining specific direction for themselves and team members to achieve the desired outcome.
• Displays creative problem-solving skills. Provides technical oversight to junior engineers and guides troubleshooting efforts.
• Demonstrates deep technical expertise in specific technical and/or clinical areas.
• Demonstrates superior productivity, independence, attention to detail, and self-motivation. Works unsupervised, exercising independent judgment within primary job functions.
• Demonstrates an understanding of all technologies and facilities across Resonetics. Is able to identify and explain opportunities for vertical integration to junior engineers and to clients.
• Maintains a growth mindset by actively seeking and accepting constructive feedback.
• Demonstrates an ability to adapt quickly and positively to changing priorities and processes.
• Demonstrates an understanding of the common inspection techniques used in medical device design and manufacturing. Incorporates Design for Metrology principles into their work. 
• Demonstrates an understanding of manufacturing priorities (efficiency, yield, line balancing). Routinely incorporates DFM and DFA principles when completing design tasks.  Enforces an NPI mindset in interactions with junior colleagues.
• Demonstrates 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.
• Demonstrates strong time management and organizational skills. Employs organizational tools to optimize personal performance.
• Demonstrates functional application of advanced Solidworks skills. Is able to coach junior engineers through complex modeling tasks.  Drafts complex drawings with a demonstrated understanding of component manufacturing methods.  Is proficient in GD&T.
• Is able to successfully contribute to multiple projects concurrently. Assists junior team members with prioritization and time management.
• Works with a clear sense of urgency and prioritizes a diverse workload.

• 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.

The compensation for this role is competitive and will be based on experience and qualifications. The anticipated range is $120,000.00 - $160,000.00.