Senior Development Engineer

2 weeks ago


San Diego California, United States Resonetics Full time
Overview:
Part of a cross-functional engineering team driving the design, development, verification, and manufacturing transfer of novel interventional medical devices.

 

 

Responsibilities:
Lead project teams through novel interventional device development while providing technical oversight, budget and timeline management, and effective customer communication

Set direction on core technical strategies for development programs

Mentor junior resources

Summarize and refine product specifications

Brainstorm novel therapeutic concepts

Perform concept refinement and generate detailed CAD design

Prototype and evaluate catheter-based designs

Perform engineering calculations, including tolerance analysis

Develop and maintain drawing packages

Develop in-vitro test methods, including fixture design and fabrication

Perform in-vivo and in-vitro study protocol development, execution, reporting

Develop manufacturing processes and documentation

Create and maintain design controls documentation

Generate product risk analyses

Foster client relationships and provide responsive service in a contract environment

Adhere to Quality Management System procedures/design controls

Participate in internal technical or process improvement initiatives

Prepare proposals, including definition of scope, timeline, and budget

Other duties as assigned

 

Qualifications:
A minimum of 5 years’ experience in medical device development

Proficiency in MS Office suite and SolidWorks

Attention to detail and comfort working in a regulated industry

Ability to present and convey complex engineering ideas to internal stakeholders and external customers

Ability to create job-related documentation for quality purposes

Ability to quickly and positively adapt to changing priorities and processes (product of input on multiple projects in customer-driven environment)

Strong communication and organizational skills

Ability to work under minimal supervision

Familiarity with ISO 13485 and 21 CFR

Compensation:
Salary- $(phone number removed)



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