Sr Design Quality Engineer (medical) - hybrid, salary, bonus + stock
ZipRecruiter, WorkFromHome
Connected Systems has a client in Lexington, MA, seeking a Senior Quality Engineer to support the full lifecycle of medical devices, including managing design controls, risk, documentation, and design changes for both new and existing products.
This role offers bonus and stock options.
Work arrangement: 2 days per week hybrid/work from home .
Responsibilities:
- Design Control & Risk Management
- Collaborate with teams on medical device software development.
- Support development and 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 and review engineering change orders.
- Assist with quality system procedure reviews and CAPA follow-up.
- Analyze data trends to improve processes.
- Participate in internal audits.
- Strong background in medical device manufacturing and software development.
- Solid knowledge of industry standards, including GMP, ISO 13485, ISO 14971, and IEC 60601.
- Experience in quality assurance for medical devices, including creation and execution of test protocols.
Required Skills:
Company Description:
Connected Systems Partners, Inc. has decades of experience providing technology recruiting and staffing services for Fortune 500 companies and startups. We specialize in Embedded Software, Firmware, Hardware/Electrical, QA/test Engineering, Mechanical, and Engineering Technicians in MA, NH, CT, and RI.
Founded in 2011, we are committed to providing excellent service to the technology workforce and organizations seeking contract, contract-to-hire, or permanent talent. Get Connected!