Design Engineering Specialist
17 hours ago
We are dedicated to making a difference in the world through cutting-edge medical technology. Our mission is to be the global leader in design, engineering, and manufacturing solutions for the medical and technology industries.
A better career for you. Creating medical technology for all.
This critical role ensures that our products meet rigorous design and quality standards, aligning with regulatory requirements and enhancing patient safety. The estimated salary for this position is $85,000 - $110,000 per year.
Key Responsibilities:
- Review and approve the translation of design input requirements into design output documents.
- Evaluate and approve design verification/validation protocols and reports to ensure compliance with design input requirements.
- Develop and apply statistical methods to verification, validation, and product inspection plans.
- Maintain and enhance risk management, verification, and validation processes to support the Quality Management System.
- Collaborate with project teams to establish and maintain Risk Management Files for products.
- Identify and assess process/product hazards, probabilities, severities, and mitigations for Risk Analyses.
- Design, execute, and analyze validations for equipment, processes, and software.
- Develop and validate test methods to support product evaluation.
- Analyze and compile reports to support verification, validation, and engineering studies.
- Evaluate the impact of equipment, design, and process changes on product quality, regulatory compliance, validation/verification, and risk profiles.
- Support post-market surveillance through data analysis and reporting.
- Monitor post-market data, including complaints, CAPAs, NCRs, and customer feedback, to update Risk Management Files.
- Investigate, document, and resolve non-conformances, CAPAs, and customer complaints as needed.
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