Job Title: Senior Design Assurance Engineer
Contract Duration 6+ Months
Pay range $45 - $70/hr
Work Type: Onsite
Location: Marlborough, MA
 
Job Summary

• The Senior Design Assurance Engineer provides design assurance support for new product development and on-market medical devices.
• This role will be responsible for facilitating the application of design controls while supporting product development, manufacturing-related design changes, maintaining regulatory compliance, implementing improvements for manufacturability, and evaluating cost reduction efforts.

• Duties are listed in order of greatest importance.
• The Senior Design Assurance Engineer may be asked to perform other function-related activities in addition to the below-mentioned responsibilities as reasonably required by business needs.
• Participate independently in a new product development project, assuring product inputs are clearly defined and assuring design verification and validation activities are appropriate and compliant to confirm input requirements are met.
• Test method validation would be an element of assuring that verification/validation is acceptable.
• Participate independently in doing thorough reviews/audits of Design History File(DHF) documentation for capital and disposable medical devices, including design plans, design inputs/outputs, verification/validation activities, design changes, and design transfer documentation.
• Participate independently in thorough reviews/audits Requirements Trace Matrix and ensure the trace matrix is accurate and meeting design control requirements for medical devices.
• Participate independently in sustaining product projects, assuring the project is clearly defined and stays on task, confirming product inputs are continuing to be met, and necessary verification, validation, and risk management activities are completed..
• The Senior Design Assurance Engineer works collaboratively with R&D to coordinate design elements of Risk Management files for product to assure compliance with applicable standards and internal policies.
• Responsible for independently coordinating the Health Risk Assessment team when needed for evaluation of on-market products, must demonstrate efficient and effective analysis of the situation, including problem definition and impact.
• Assess change requests of the product for impact on design, and determine supporting information required for implementation of changes.

• Technical Bachelor Degree

• 2-5 years' experience, preferably inthe  medical device industry

• Experienced with FDA Quality System Regulations, especially Design Control requirements, ISO 13485, and Medical Device Directive
• Experienced with ISO 14971, Risk Management
• Familiarity with Usability, Reliability, Electrical Safety, Software, Sterilization, Packaging, and Biocompatibility standards and requirements.
• Working knowledge of verification and validation requirements for a regulated product
• Working knowledge of requirements analysis, including development of testable and measurable specifications
• Ability to effectively work on project teams, including taking a leadership role on critical tasks to assure appropriate and timely completion/resolution
• Ability to appropriately assess written product and project documentation as the principal advocate for compliance, and ability to effectively communicate assessment

• Working knowledge of test method validation, root cause failure analysis, statistical methods, and design of experiments

• A thorough completion of this section is needed for compliance with legal standards such as the Americans with Disabilities Act.
• The physical requirements 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
• Sit; use hands to finger, handle, or feel objects, tools, or controls.
• Stand; walk; reach with hands and arms; and stoop, kneel, crouch, or crawl.
  
  

• Works with Divisional personnel and Costa Rica personnel, including R&D, Regulatory, Marketing, PMQA, Manufacturing Engineering, and Quality Engineering 
  
  

• Medical, Vision, and Dental Insurance Plans
• 401k Retirement Fund
  
  

• Innovative medical technology company empowering healthier lives. Focuses on women's health and well-being. Offers products to detect, diagnose, and treat illnesses earlier. Driven by talented employees and a commitment to science-based solutions.
  
  

• GTT is a minority-owned staffing firm and a subsidiary of Chenega Corporation, a Native American-owned company in Alaska. As a Native American-owned, economically disadvantaged corporation, we highly value diverse and inclusive workplaces. Our clients are Fortune 500 banking, insurance, financial services, and technology companies, along with some of the nation's largest life sciences, biotech, utility, and retail companies across the US and Canada. We look forward to helping you land your next great career opportunity!