Product Development Engineer III

Overview:

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.

Responsibilities:

• 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

• 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

• Presents content in customer meetings with the support of team members. Communicates directly

• 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

• Demonstrates a developing breadth of technical and clinical experience.
• Demonstrates an ability to work under minimal supervision, taking responsibility for completion

• Has awareness of Resonetics technologies and facilities sufficient to collaborate effectively on

• Identifies and reports unmet customer needs applicable to Resonetics technology to the Advanced

• Maintains a growth mindset by actively seeking and accepting constructive feedback
• Demonstrates leadership and mentorship by seeking opportunities to share knowledge and

• Completes complex tasks with minimal direction.
• Demonstrates an ability to adapt quickly and positively to changing priorities and

• Communicates in a respectful and professional manner with peers regarding technical and

• Demonstrates familiarity with foundational process development techniques used in the assembly

• Troubleshoots/leads process development activities as needed.
• Presents and conveys complex engineering concepts to internal and external stakeholders, with

• Demonstrates a foundational understanding of inspection techniques and their significance in

• Demonstrates good time management and organizational skills.
• Demonstrates an understanding of manufacturing priorities (efficiency, yield, line

• Demonstrates a foundational understanding of DFM and DFA principles.
• Manages and executes multiple tasks concurrently, maintaining relative priority to deliver

• Effectively communicates with project leadership to identify and troubleshoot competing

• Successfully contributes to multiple projects concurrently.

Qualifications:

• 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

• Experience in multiple medical device development phases, including those

guided by Design Controls requirements.