7+ years v&v experience in medical device industry
Systems engineering principles and product lifecycle knowledge
Requirements management tools like doors or jama
This role leads a team to ensure robotic products meet all defined system requirements and are safe, effective, and compliant for clinical use
Job Summary
This role leads a team to ensure robotic products meet all defined system requirements and are safe, effective, and compliant for clinical use.
The position involves developing comprehensive V&V strategies, managing external test facilities, and overseeing the maintenance of robotics test lab facilities.
Employees are eligible for a base pay range of $137,000.00 - $235,750.00 along with retirement plans, long-term incentives, and extensive leave benefits.
Matching Summary
This role leads a team to ensure robotic products meet all defined system requirements and are safe, effective, and compliant for clinical use.
Salary
Base: $137,000.00 - $235,750.00; Bonus/Equity: Eligible for long-term incentive program; Benefits: Pension, 401(k), vacation, sick time, parental leave, and holiday pay
Skills & Requirements
Must-have
7+ years V&V experience in medical device industry
Systems engineering principles and product lifecycle knowledge
Requirements management tools like DOORS or Jama
FDA 21 CFR Part 820 and ISO 13485 compliance expertise
Team leadership for Verification and Integration Engineers
Nice-to-have
Experience with Class II or Class III medical devices
Familiarity with test automation tools and scripting languages
Knowledge of embedded systems and firmware testing
Six Sigma or CQE/CQA certification preferred
Statistical methods proficiency for sample size calculation
Key Requirements
Bachelor's or master's degree in biomedical or related engineering field
7+ years of experience in V&V engineering within medical devices
Proficiency in requirements management tools such as DOORS, Jama, or Polarion