Research & Development Engineer I
- Design and development of innovative concepts for changes to new and existing medical devices.
- Prototype and evaluate early-stage design changes using various rapid prototyping techniques (3D printing, machining, etc.) to prove design concepts.
- Support design verification activities for design changes, develop and execute design verification protocols to ensure product meets defined technical requirements.
- Contribute to design FMEA documentation to identify and mitigate design failure modes.
- Collaborate with marketing and sales groups to translate user needs and voice of customer to product design.
- Research and specify materials based on biocompatibility, mechanical properties, etc.
- Support engineering project tasks related to cost improvement projects and new product transfers.
- Implement and evaluate changes to existing processes designed to improve product quality, productivity, and overall equipment efficiency.
- Create and/or revise existing CAD models and drawings using SOLIDWORKS.
- Design and execute engineering studies, and analyze data using Excel and MINITAB.
- Apply statistical methods to estimate future manufacturing requirements and potential.
- Coordinate with vendors to determine product specifications and arrange for purchase of equipment, materials, or parts, and evaluates products according to specifications and quality standards.
- Apply statistical process control (SPC) methods for analyzing data to evaluate design requirements.
- Maintain a working knowledge of government and industry quality assurance codes and standards.
- Responsible for preparing and managing specifications for new and existing products.
- Maintain knowledge of good manufacturing practices and documentation, preferably in the medical industry, experiment design, management of statistical procedures, and knowledge of computer programs.
- Develop, evaluate, and improve manufacturing methods; modify processes to improve safety and product quality, and/or reduce costs.
- Responsible for writing and executing test protocols and reports.
- All other duties as assigned by the Engineering Manager.
- Bachelor's degree from four-year College or University in engineering or science preferred with 1-2 years of related experience and/or training. No degree and at least 5 years’ experience of specific experience with medical device manufacturing
- SOLIDWORKS and MINITAB experience preferred
- Experience or education related to design verification and validation
- Experience or education related to technical writing in an engineering context
- Excellent verbal and written communications required; strong facilitation and interpersonal skills required
- Experience with statistical software program preferred (MINITAB, etc.)
- To perform this job successfully, an individual should have knowledge of spreadsheet software and word processing software. Review drawings, key characteristics, tolerances, notes, specifications, etc.
- Provide SolidWorks CAD support
- Experience in design for manufacturing preferred
- Problem Solving/Analysis
- Results Driven
- Detail Orientation
- Customer Focus
- Technical Capacity
- Communication Proficiency
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