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Sr R/D Engineer-Medical Device-Only W2
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R&D Engr II
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R&D Engineer II
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R&D Engineer II
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Principal R&D Mechanical Engineer
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Senior R&D Engineer
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![Intellectt Inc](https://media.trabajo.org/img/noimg.jpg)
R&D/NPD Engineer(Medical device)
1 month ago
Responsibilities:
- Lead and contribute to the design, development, and testing of new medical devices in accordance with project goals and regulatory requirements (e.g., FDA, ISO).
- Develop and implement robust test methods and protocols for design verification and validation activities.
- Conduct feasibility studies, risk assessments, and ensure compliance with regulatory standards throughout the product development lifecycle.
- Collaborate with manufacturing engineering to optimize designs for manufacturability, scalability, and cost-effectiveness.
- Work closely with manufacturing teams to transfer new products into production, ensuring smooth transition and adherence to quality standards.
- Generate and maintain detailed design documentation, including specifications, drawings, and reports.
- Support regulatory submissions and address any design-related queries from regulatory bodies.
- Stay current with industry trends, technologies, and best practices to drive innovation and continuous improvement.
Requirements:
- Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, or related field (Master’s degree preferred).
- 6 years of experience in R&D/NPD within the medical device industry.
- Proficiency in CAD software (e.g., SolidWorks) and familiarity with design control processes.
- Strong analytical skills and ability to solve complex technical problems.
- Experience with test method development, validation protocols, and statistical analysis.
- Knowledge of manufacturing processes, materials, and quality systems (e.g., Six Sigma, Lean Manufacturing).
- Excellent communication skills and ability to work effectively in a team environment.
- Knowledge of regulatory requirements and standards (e.g., FDA 21 CFR Part 820, ISO 13485).