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Verification and Validation Engineer (Medical Device)

About True Digital Surgery®

With a nearly two-decade legacy of creating cutting-edge medical devices, True Digital Surgery® is advancing its innovative 3D surgery digital platform through the integration of optics and robotics with augmented reality and machine learning that result in life-extending outcomes for both surgeons and patients.

 

SUMMARY

The Medical Device Verification and Validation Engineer’s main focus will be to support the design and development team by maintaining a V&V program for new and existing product development.  He/She will be responsible for writing, reviewing, and executing verification and validation test protocols in accordance with federal and international regulatory requirements.  This role involves working closely with internal and external cross-functional team members, understanding clinical use case and workflows, and understanding medical device design process. Applicants with strong communication and cross functional team working skills, as well as the ability to be proactive and work independently are highly considered.

 

ESSENTIAL DUTIES AND RESPONSIBILITIES

Include the following.  Other duties may be assigned.

  • Heavy participation in requirements development and analysis.
  • Create test equipment, fixtures including design of hardware, software
  • Experience writing test scripts using Matlab or equivlent
  • Writing and reviewing verification and validation test protocols.
  • Execute test protocols and author test reports.
  • Maintain IOVV documentation and product requirement traceability matrix 
  • Perform required data analysis using statistical techniques.
  • Manage and coordinate external test laboratory activities.
  • Research of applicable design and test standards.
  • Develop sterilization and biocompatibility test protocols.
  • Create Usability test requirements and protocols for product development and design validation.

 

QUALIFICATIONS

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

 

Education/Experience

Typically requires a minimum of 4 years of related experience with a Bachelor’s degree; or 2 years and a Master’s degree; or a PhD without experience; or equivalent work experience.

 

Language

Ability to read, analyze, and interpret professional journals, technical procedures, or governmental regulations.  Ability to write reports, business correspondence, and procedure manuals.  Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public. Knowledge of the structure and content of the English language including the meaning and spelling of words, rules of composition, and grammar.

 

Additional Skills

To perform this job successfully, an individual should have knowledge of Microsoft Word, Excel and Outlook or equivalent. 

The following medical device development experience is preferred:

  • Author of Class II  device design V&V documentation. Lead or involved in FDA 510(k) submissions.
  • Working knowledge of Risk management techniques, ISO 14971
  • Knowledge of different medical imaging modes such as optical microscopy, intraoperative fluorescence, CT, MRI, etc.
  • Experience developing test methods and fixtures in support of V&V testing.
  • Understanding of basic digital image processing concepts and techniques
  • Basic knowledge of the human’s body anatomy and physiology
  • Working knowledge of Scrum or other Agile development methodologies
  • Broad knowledge of engineering concepts (EE, ME, SW, data analysis, modeling)

 

Physical Requirements

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this Job, the employee is regularly required to sit; use hands to finger, handle, or feel; reach with hands and arms and talk or hear. The employee must occasionally lift and/or move up to 50 pounds and frequently lift and/or move up to 10 pounds. Specific vision abilities required by this job include color, distance and close vision.

Work Environment

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is frequently exposed to work near moving mechanical parts. The noise level in the work environment is usually moderate.

Benefits:

We value our employees’ time and efforts. Our commitment to your success is enhanced by our competitive compensation and an extensive benefits package including paid time off, medical, dental and vision benefits and future growth opportunities within the company. Plus, we work to maintain the best possible environment

To Apply:

To respond to this opportunity, please apply through this ad.

For more information about us, please visit www.truedigitalsurgery.com

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.

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