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.
Resonetics is a global leader in advanced engineering, prototyping, product development, and micro manufacturing, driving innovation in the medical device industry. With rapid expansion across all our locations, we continue to push the boundaries of technology while fostering a dynamic, employee-centered culture. 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 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.

Required 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

materials.

• Experience in multiple medical device development phases, including those

guided by Design Controls requirements.Preferred Qualifications:

• Bachelor of Science degree in an engineering / science or equivalent experience

Physical Demands:

• Standing and walking for short periods of time
• Ability to use a microscope, including manipulating small objects under a microscope.

Compensation:
The compensation for this role is competitive and will be based on experience and qualifications. The anticipated range is $77,000.00 - $96,000.00.
Join Resonetics and be part of a team that’s redefining medical device manufacturing. If you’re passionate about innovation and thrive in a fast-paced environment, we’d love to hear from you.

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 an

of assigned tasks.

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