Overview
Part of a cross-functional engineering team driving the design, development, verification, and manufacturing transfer of novel interventional medical devices.
Responsibilities
Salary- $95,000-120,000
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
- 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
Salary- $95,000-120,000
-
Seniority level
Mid-Senior level -
Employment type
Full-time -
Job function
Engineering and Information Technology -
Industries
Manufacturing
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