New Product Introduction Engineer - Catheter

Overview:

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.

Part of a cross-functional engineering team driving the design, development, verification, and manufacturing transfer of

novel interventional medical devices. The NPI Engineer - Catheter role has responsibility for the transition of new projects from early-stage development into controlled builds and sustained manufacturing, including process development in early prototype builds, input to design for assembly, and generation of supporting documentation necessary to manufacture product.

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:

• Designs assembly and test fixtures with little to no oversight. Implements DFA improvements on complex medical device assemblies.
• Assists with implementation of validation/qualification studies on complex medical device assemblies.
• Identifies and implements line balancing/process optimization activities with little oversight.
• Demonstrates an understanding of best practices for formatting Manufacturing Process Instructions. Provides effective training on medical device assembly processes.
• Independently works through complex problems with some input from Senior colleagues.
• Has experience in multiple development phases, including those guided by Design Controls requirements. 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 functional technical and clinical understanding of products being actively worked on. Demonstrates a developing breadth of technical process expertise.
• Authors single phase proposals and project timelines with guidance. Participates in calls with prospective clients as a secondary technical resource.
• 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.
• Presents content in customer meetings with the support of team members. Communicates directly with clients in a timely and professional manner.
• 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.
• Demonstrates familiarity with foundational process development techniques used in the assembly of catheter-based devices. Troubleshoots/leads process development activities as needed.
• Communicates in a respectful and professional manner with peers regarding technical and non-technical subject matter.
• Presents and conveys complex engineering concepts to internal and external stakeholders, with appropriate consideration toward timeliness and method of communication.
• Demonstrates an understanding of the common inspection techniques used in medical device design and manufacturing. Incorporates Design for Metrology principles into their work.

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
• Foundational SolidWorks skills.
• A developed understanding of materials science and materials properties for common medical device materials.