Research And Development Engineer
2 hours ago
Job Description:
- Mechanical engineer with a 5+ years design control and project management experience.
- Proven ability to lead multiple / complex sustenance engineering projects and lead the cross-functional teams (i.e., R&D, Marketing, Quality, Regulatory, Manufacturing, Operations, Medical Affairs etc.) to deliver the design solutions.
- Experience in contributing/leading Design change controls, Design reviews and Design transfer.
- Strong written and verbal communications skills. Ability to write and independently analyze results of technical reports.
- Knowledge of the following standards: 21 CFR Part 820.30, ISO 13485, and ISO 14971.
- Development and release of design control documentation. Lead appropriate documentation of activities in accordance with existing policies and procedures (Divisions, Corporate, and Regulatory compliance)
- Lead creation and execution of Design verification protocols, summarize results, enable formal design reviews and own the verification portion of the Design History File.
- Application of engineering first principles and advanced engineering methods to gain deep understanding of the underlying technical issues, and to propose and implement robust solutions
- Optimize product design, material selection, product features, process design and human factor needs based on the project needs.
- Coach and mentor junior engineers and technicians to execute project deliverables.
Consider this as a Call Letter
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