Medical V&V Manager

Leads all company activities related to Verification and Validation of new products, as well

as related instrumentation and their handling.

• Defines, supervises and executes V&V masterplan for products and bench tests, in order to

ensure product compliance with applicable regulatory standards.

• Professional responsibility over BioAnalytics in the company.

Duties and Responsibilities

• Prepares V&V protocols and reports throughout product lifecycle (URS, PRS, Design

Reviews, final product design validation tests).

• Manages V&V team, including engineers, technicians and students, as well as their

professional training and supervision.

• Has overall responsibility for company’s Risk Management process.

• Defines and writes testing work instructions.

• Supports engineering, manufacturing and QC activities, participates in ECO and MRB

processes.

• Defines requirements for testing and inspection setups.

• Manages third party testing and validation activities.

• Works closely with other R&D, QA, Regulatory and product team leaders.

Qualifications (Education, Skills, and Experience)

Required

• Education - B.Sc. equivalent or higher, Biomedical Engineering.

• At least 5 years of experience in V&V of medical devices.

• Very high interpersonal skills.

• Excellent technical writing skills (English and Hebrew).

Advantages

• Experience in orthopedic products

• Experience in a QMS environment

• Familiarity with ISO 13485

• Managerial experience