Verification and Validation Engineer / Senior V&V Engineer

Job Description

This is for mechanical engineering (physical testing). If you're system / software base, please do not apply

Verification and Validation Engineer / Senior V&V Engineer

Direct Hire Full-Time Role

Salary Range : $120,000 - $150,000 per year

Location : Santa Clara, CA - Onsite Role

Duties and Responsibilities :

• Conduct design verification and validation testing for product development activities
• Support all technical aspects of the product and instruments.
• Support regulatory requirements.
• Support the design control process.
• Support sustaining engineering activities with root cause and engineering analysis.
• Lead the engineering change process.
• In the event of potential non-compliance with applicable standards or regulations (e.g. FDA QSRs, ISO 13485, or ISO14971), the employee has the authority to hold any product or QA / RA documentation from shipment or further processing. The employee has the responsibility to report any instances to their direct supervisor or above.
• The V&V Engineer must at all times act and conduct company business in an honest, ethical, and strictly legal manner, complying with the Code of Conduct, other company policies, the AdvaMed Code, and all applicable laws and regulations, whether national, regional, state, or local. This individual is encouraged, expected, and required to report any suspected violations of laws, regulations, the Code, or any other Company policy, and all other suspected unethical behavior. The company does not tolerate retaliation in connection with making good faith reports of suspected violations.
• Be the verification and validation lead assisting the product development group in developing products to ensure constantly improved instrumentation and cutting-edge technology.
• Write protocols, assessments, conduct testing, and write test reports (e.g., performance, simulated use).
• As needed, source appropriate vendors to conduct testing and oversee their testing

Requirements and Qualifications :

Desired Skills and Experience

design verification, validation testing, product development, technical support, regulatory requirements, design control process, sustaining engineering, root cause analysis, engineering analysis, engineering change process, FDA QSRs, ISO 13485, ISO14971, protocol writing, performance testing, simulated use testing, test reports, vendor sourcing, vendor management, medical device, orthopedics, spine, organization skills, planning, scheduling, technical writing, ISO standards, ASTM standards, cross-disciplinary collaboration, engineering, manufacturing, operations, R&D, product marketing, clinical, regulatory, quality assurance, mechanical test fixtures, fixture design, fabrication, machining, mill, lathe, 3D printing, mechanical testing

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