ABOUT US

True Digital Surgery is a World Leader in Computer-Guided Microsurgery. We combine 3D visualization and guidance software applications focused on improving accuracy, efficiency and outcomes for surgeons and patients. Our medical imaging and guidance system employs advanced real-time 3D graphic capabilities and proprietary software that is sold to surgeons and hospitals all over the world.

SUMMARY

This position is responsible for writing, maintaining, reviewing, and executing verification and validation test protocols and to qualify new medical imaging software and hardware products to ensure quality control standards are achieved. 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 teamworking skills, as well as the ability to be proactive and work independently are highly considered.

ESSENTIAL DUTIES AND RESPONSIBILITIES

Executes verification and validation processes in the development phases and for release of medical devices by performing the following duties. Other duties may be assigned. 

• Write, maintain, review, and execute test plans and test results
• Document software requirements, testing traceability, defect tracking, and software risk analysis
• Follow quality process for release of software and documentation through engineering change orders
• Participate in efforts to develop automated tests
• Perform hardware troubleshooting, testing and quality assurance
• Perform software testing and QA procedures
• Development of work instructions and improvement of quality process documentation

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.

Language

Demonstrate excellent communication and documentation skills, both written and oral. Ability to read, analyze, and interpret technical procedures or governmental regulations. Ability to write reports and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the public. 

Math

Demonstrate ability to calculate figures and amounts such as discounts, interest, commissions, proportions, percentages, area, circumference, and volume. Apply concepts of basic algebra and geometry.

Reasoning

Demonstrate ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Interpret a variety of instructions furnished in written, oral, diagram, or schedule form.

Computer Skills

To perform this job successfully, an individual should have strong computer skills (avid recreational or professional use).

Knowledge, Skills & Ability:

• Fundamental understanding of software systems, testing, and release
• Strong organizational and communication skills
• Strong writing and documentation skills
• Experience with troubleshooting different computer problems
• Ability to write test plans and test cases based on software documentation
• Work well in a team-oriented environment.
• Attention to detail
• Energetic, can-do attitude, completes tasks thoroughly
• Enjoy working in fast-paced environment

Education/Experience

• Bachelors of Science degree in related field or 5 years relevant work experience in medical device SQA

• Self-starter with ability to work independently

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.