Senior Development Engineer

Overview:

We have an exciting opening at our Westborough, Massachusetts location. Resonetics is searching for a Senior Development Engineer to join our growing team. This role will be a part of a cross-functional engineering team driving the design, development, verification, and manufacturing transfer of novel interventional medical devices.

Our commitment to excellence and continuous improvement makes Resonetics an exciting place for professionals passionate about shaping the future of micro-manufacturing and being part of something bigger.

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 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.
• Authors single phase proposals and project timelines with little guidance.
• Exercises engineering leadership on internal and external meetings. Drives conversations towards desired goals and outcomes in a respectful and professional manner.
• 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 catheter-based 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.
• 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 functional application of advanced SolidWorks skills. Coaches junior engineers through complex modeling tasks.

Qualifications:

• 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.