Senior Development Engineer
2 weeks ago
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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