Sustaining Engineering Specialist Role
hace 5 días
Responsibilities
- Providing clear communication to stakeholders at key technical updates
- Leading the design & execution of structured experimental plans to drive data-based decisions
- Understanding the anatomy, clinical use cases, and user interface requirements to drive design decisions
- Knowledge in design controls for design changes
- Supporting and successfully contributing to project teams through various activities including product design and development, test of materials, preparation of specifications, process capability studies, research investigations, report preparation, and process/test documentation
- Providing work direction to technicians/entry-level engineers
- Performing troubleshooting on products/process problems related to design, material, or process
- Selecting techniques to solve complex problems and make sound design recommendations
- Summarizing, analyzing, and drawing conclusions from complex test results
- Designing and preparing complex reports to communicate results to the technical community
- Designing and coordinating complex engineering tests and experiments
- Coordinating, managing, and documenting project goals and progress and recommending appropriate revisions
- Assessing the feasibility and soundness of proposed engineering evaluation tests, products, or equipment
- Understanding customer needs and their relationship to product requirements and design specifications
- Responsible for engineering documentation
- Working cooperatively with quality, manufacturing, regulatory, clinical, and marketing on complex projects to ensure project success
- Guiding, coaching, directing, and developing direct reports
- Providing guidance to less experienced engineers (direct and non-direct reports) during design changes and regular Sustaining activities
Requirements
- Licentiate or Master's degree in Chemistry, Industrial Chemistry, Materials Engineering, Chemical Engineering, Mechanical Engineering, or similar
- Required minimum years of work experience (primarily in medical device or related field): 5+ Years
- Experience in design analysis techniques
- Experience managing technical aspects of projects as a member of a cross-functional core team
Preferred Qualifications
- Demonstrated ability to provide technical leadership on a large-scale development program
- Solid clinical knowledge and experience in cardiovascular anatomy
- Ability to draw conclusions and make recommendations based on technical inputs from multiple and varied sources
- Excellent organizational, communication, and collaboration skills
- Demonstrated product development leadership and communication skills
- Experienced with multi-faceted technology and product development programs
- Ability to research literature and develop clinical understanding with technical credibility to develop a strategy for regulatory submission
- Class II or Class III Medical Device experience
- Solid experimental design and statistical analysis knowledge
- Experiences working with complex polymer systems, advanced degrees a plus especially with research experience
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