Sr Design Quality Engineer (medical) - hybrid, salary, bonus + stock

Job DescriptionJob Description

Connected Systems has a client in the Lexington, MA looking for a Senior Quality Engineer to support the full lifecycle of medical devices, managing design controls, risk, documentation, and design changes for new and existing products.

This role offers bonus and stock options.

2 Days per week hybrid/work from home.

Responsibilities:

Design Control & Risk Management

• Collaborate with teams on medical device software development.
• Support development/qualification of software tools.
• Review test cases, results, and design documentation.
• Participate in risk management per ISO 14971, IEC 62304, ANSI/AAMI SW96.
• Support compliant product design changes.

Quality System

• Prepare/review engineering change orders.
• Assist with quality system procedure reviews and CAPA follow-up.
• Analyze data trends to improve processes.
• Participate in internal audits.

Required Skills:

• Strong background in medical device manufacturing and software development.
• Solid knowledge of key industry standards, including GMP, ISO 13485, and ISO 14971 and IEC 60601
• Skilled in quality assurance for medical devices, including creation and execution of test protocols.

Company DescriptionThe experts at Connected Systems Partners, Inc. have decades of successful experience providing technology recruiting and staffing services for Fortune 500 companies to new business start-ups.
We specialize in Embedded Software, Firmware, Hardware/Electrical, QA/test Engineering, Mechanical and Engineering Technicians, in MA, NH, CT and RI.
Since our founding in 2011, Connected Systems Partners has been providing a superior level of service to the technology workforce, looking to advance their careers and organizations looking to add contract, contract to hire, or permanent talent to their teams.
Get Connected!Company DescriptionThe experts at Connected Systems Partners, Inc. have decades of successful experience providing technology recruiting and staffing services for Fortune 500 companies to new business start-ups. \r\nWe specialize in Embedded Software, Firmware, Hardware/Electrical, QA/test Engineering, Mechanical and Engineering Technicians, in MA, NH, CT and RI.\r\nSince our founding in 2011, Connected Systems Partners has been providing a superior level of service to the technology workforce, looking to advance their careers and organizations looking to add contract, contract to hire, or permanent talent to their teams. \r\nGet Connected!