Senior Product Development Engineer

Part of a crossfunctional 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 catheterbased designs.
• Performs engineering calculations including tolerance analysis.
• Drafts complex drawings with a demonstrated understanding of component manufacturing methods.
• Develops invitro test methods including fixture design and fabrication.
• Performs invivo and invitro study protocol development reporting.
• Develops manufacturing processes and documentation.
• Creates and maintains designs controls documentation.
• Generates product risk analyses.
• Participates in internal technical or process improvement initiatives.
• Leads customer meetings. Communicates directly with clients in a timely and professional manner.
• Authors single phase proposals and project timelines with little guidance.
• Participates in calls with prospective clients as a subject matter expert.
• 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 with appropriate consideration toward timeliness and method of communication.
• Identifies and reports unmet customer needs applicable to Resonetics technology to the Advanced Technology Group.
• Demonstrates expertise in a range of process development techniques used in the assembly of catheterbased devices. Troubleshoots/leads process development activities as needed.
• Completes complex tasks with minimal direction with a demonstrated ability to break large problems into actionable pieces.
• Displays creative problemsolving skills. Works through complex systemlevel issues with little to no guidance.
• Demonstrates developing depth of clinical or technical expertise in distinct areas.
• Demonstrates productivity independence and attention to detail while working under minimal supervision. Attempts to solve problems independently soliciting input from project leadership on an infrequent basis. Continuously seeks out additional responsibilities.
• 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.
• Demonstrates familiarity and compliance with Quality SOPs. Understands requirements sufficiently to advise junior engineers in Product Development Process (PDP) requirements.
• Demonstrates strong time management and organizational skills. Employs organizational tools to optimize personal performance.
• Demonstrates functional application of advanced SolidWorks skills. Coaches junior engineers through complex modeling tasks.
• Works with a clear sense of urgency and prioritizes a diverse workload effectively.
• Successfully contributes to multiple projects concurrently. Assists junior team members with prioritization and time management

• 5 years experience in the medical device design/development field.
• Proficient in Microsoft Office: MS Teams Excel PowerPoint Outlook.
• Strong understanding of ISO 13485 sufficient to participate in an audit and/or guide junior engineers.
• Advanced SolidWorks skills.
• Comprehensive knowledge of materials science and material properties for common medical device materials.
  Specialized depth of expertise in one or more technical areas.
  Experience in multiple development phases including those guided by Design Controls requirements.

The compensation for this role is competitive and will be based on experience and qualifications. The anticipated range is $100000$125000.