Quality Engineer

Title: Design Verification Engineer


Duration : 5 Months


Location: Cambridge, MA, 02141

Job Description


This position is responsible for the design, development, documentation and execution of all design verification plans, schedules, test protocols and reports to ensure the Measurement Sensors Platform at Clients meets published specifications and are compliant with Quality System Regulations. This engineer will work on hemodynamic monitoring medical products.

Position responsibilities:

• Responsible for developing and executing verification test plans and compiling results in accordance with processes.
• Develops risk based and statistically significant sampling plans for technical requirements.
• Participates in a cross functional team supporting design reviews, hazard analysis and risk assessments to ensure high standards are met.
• Participates in root cause analysis for defects and provides process improvement suggestions to eliminate future occurrences of similar defects.
• Uses Defect Tracking System to report and/or resolve product issues.
• Participate in cross-functional project team meetings.
• Maintains projects and documentation according to ISO and GMP guidelines, while following the Clients design controls and associated processes.
• Maintains current knowledge in latest testing methodologies.
• Maintains current knowledge to ensure compliance to applicable regulatory and corporate domestic and international standards/requirements (e.g., FDA QSR, ISO 13485, MDD) as they apply to verification activities of the Design Control process.
• Coordinates work with third party test houses as required.
• Performs duties in compliance with environmental, health and safety related site rules, policies or governmental regulations.
• Performs other related duties as assigned.
• Travel requirement: 50%

Essential requirements:

• B.S. or M.S. in Biomedical, Mechanical, or Electrical Engineering or similar related field
• Minimum 2 years engineering / R&D experience in rigorous quality focused environment
• Excellent oral, written and presentation skills

Preferred requirements:

• Use of statistical tools like Minitab preferred
• Working knowledge of IEC60601 and other common ISO standards used in testing of Medical Devices
• Working knowledge of biocompatibility with respect to medical devices
• 2 years of verification experience
• Applying statistical knowledge to practical problems
• Developing risk based and statistically significant sampling plans
• Strong analytical and problem solving skills
• Self-motivated person that can work individually and be part of a cross functional team
• A self-starter with a strong desire to learn new concepts and adapt quickly