V&V Mechanical Engineer
Engineer, V&V with Mitigation Experience
The selected candidate must be a degreed engineer, with direct medical device experience in a ISO enviroment
- V&V, Design History files, FDA Regulations, Risk Management
ISO 13485, ISO 14971, IEC 62304, IEC 60601, cGMP, GAMP 4, DMR, CAPAs, NCRs, DMR, DFMEcA, GxP
Job function includes:
• Design test plans, scenarios, scripts, or procedures.
• Test system modifications to prepare for implementation.
• Develop testing programs that address areas such as database impacts, software scenarios, regression testing, negative testing, error or bug retests, or usability.
• Risk management and risk analysis including FMEA.
• Coordinate the implementation or scheduling of validation testing with affected departments and personnel.
• Study product characteristics or customer requirements and confer with management to determine validation objectives and test plans.
• Review validation and compliance documentation.
• Resolve testing problems by modifying testing methods or revising test objectives and requirement.
• Identify deviations from established product or process standards and provide recommendations for resolving deviations.
• Participate in product design reviews to provide input on functional requirements, product designs, schedules, or potential problems.
• Review software documentation to ensure technical accuracy, compliance, or completeness, or to mitigate risks.
Identify opportunities or implement changes to improve products or reduce costs using knowledge of fabrication processes, injection molding, tooling and production equipment, assembly methods, quality control standards, or product design, plastic housing materials and parts.
• Determine root causes of failures using statistical methods and recommend changes in designs, tolerances, or processing methods
Excellent written communication skills are required, as is the use of MS Office, Word, Excel
Degreed Engineer 5+ years medical device ISO standards, EU Standards
Job Status: Contract/Temporary