The Product Development Engineer is part of a cross-functional engineering team driving the design, development, verification, and manufacturing transfer of novel interventional medical devices. The individual reports to the Director of Product Development.

• 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 input from senior team members.
• Participates in in-vitro test method development, including fixture design and
fabrication.
• Participates 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.
• Authors single phase proposals and project timelines with guidance. Participates in calls with
prospective clients as a secondary technical resource.
• Presents content in customer meetings with the support of team members. Communicates directly
with clients in a timely and professional manner.
• Independently works through complex problems with some input from senior colleagues.
• Demonstrates familiarity and compliance with Quality SOPs.
• Demonstrates a strong understanding of ISO 13485, sufficient to participate in an audit and/or
guide junior engineers.
• Demonstrates a developing breadth of technical and clinical experience.
• Demonstrates an ability to work under minimal supervision, taking responsibility for completion
of assigned tasks.
• Has awareness of Resonetics technologies and facilities sufficient to collaborate effectively on
active projects.
• Identifies and reports unmet customer needs applicable to Resonetics technology to the Advanced
Technology Group.
• Maintains a growth mindset by actively seeking and accepting constructive feedback

• Demonstrates leadership and mentorship by seeking opportunities to share knowledge and
experience with colleagues. May formally mentor co-op.
• Completes complex tasks with minimal direction.
• Demonstrates an ability to adapt quickly and positively to changing priorities and
processes.
• Communicates in a respectful and professional manner with peers regarding technical and
non-technical subject matter.
• Demonstrates familiarity with foundational process development techniques used in the assembly
of catheter-based devices.
• Troubleshoots/leads process development activities as needed.
• Presents and conveys complex engineering concepts to internal and external stakeholders, with
appropriate consideration toward timeliness and method of communication.
• Demonstrates a foundational understanding of inspection techniques and their significance in
medical device design and manufacturing.
• Demonstrates good time management and organizational skills.
• Demonstrates an understanding of manufacturing priorities (efficiency, yield, line
balancing).
• Demonstrates a foundational understanding of DFM and DFA principles.
• Manages and executes multiple tasks concurrently, maintaining relative priority to deliver
against target completion dates.
• Effectively communicates with project leadership to identify and troubleshoot competing
priorities that may impact ability to meet deadlines.
• Successfully contributes to multiple projects concurrently.

• 3+ years' experience in the medical device design/development field.
• Proficient in Microsoft Office: MS Teams, Excel, PowerPoint, Outlook.
• Familiarity with ISO 13485 and 21 CFR
• Advanced Solidworks skills.
• A developed understanding of materials science and material properties for common medical device
materials.
• Experience in multiple medical device development phases, including those
guided by Design Controls requirements.