Job Description

Verification and Validation Engineer/Senior V&V Engineer

Direct Hire Full-Time Role

Salary Range: $115,000 - $135,000 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:

• BS in an engineering discipline (Mechanical engineering preferred)
• Currently or recently served as V&V engineer for a high-growth, medical device organization whose products are marketed to a medical specialty practice and worked in that capacity for a minimum of 3 years. Experience in orthopedics is highly desired; spine experience is also a plus.
• Exceptional organization/planning skills (e.g., scheduling) and display initiative and perseverance in meeting deadlines.
• Good technical writing skills with attention to detail.
• Currently or recently performed testing to established standards (i.e., ISO, ASTM).
• Have a demonstrated ability to communicate effectively and work well with co-workers, surgeons, clinicians, and distributor reps.
• I have a cross-disciplinary working understanding of a medical device business, emphasizing engineering, manufacturing, operations, R&D, product marketing, clinical and regulatory, and quality assurance.
• Be known as a person who has high integrity, sound character, a tremendous work ethic, and the passion to succeed.
• Currently or recently designed and fabricated mechanical test fixtures to perform mechanical testing using machining (e.g., mill, lathe) or 3D printing.
• A passion for supporting an emerging company and sustaining high growth through engineering support.

Desired Skills and Experience

Design verification and validation testing, product development support, regulatory compliance, design control process, sustaining engineering, root cause analysis, engineering change management, FDA QSR compliance, ISO 13485 compliance, ISO 14971 compliance, test protocol writing, performance testing, simulated use testing, test report writing, vendor sourcing and management, mechanical engineering, orthopedic medical device experience, spine medical device experience, project planning and scheduling, technical writing, ISO testing standards, ASTM testing standards, cross-functional collaboration, mechanical test fixture design, test fixture fabrication, machining skills, 3D printing, mill operation, lathe operation, R&D support, manufacturing support, operations support, product marketing support, clinical support, regulatory affairs support, quality assurance, medical device industry experience, V&V leadership

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