Device Manufacturing Engineer

Department: QSI-TEAMS Institute
Salary/Grade: EXS/9

This opportunity provides hands-on technical assistance in a dynamic, translational engineering environment. The role focuses on supporting the build-out and maintenance of quality systems, facility operations, and manufacturing/testing processes for advanced medical technologies and devices. This position contributes directly to QSI-TEAMS' mission of fast-tracking engineering-driven innovations to improve patient care.

Work is performed in a combination of standard office environments and specialized areas including a variety of research laboratories, manufacturing spaces, and clean rooms. Employees must adhere to cleanroom gowning, safety, and quality-system protocols as required.

• Help develop, review, and implement standard operating procedures (SOPs), protocols, batch records, and technical reports.
• Assist with project tasks such as data collection, progress tracking, and preparation of reports or documentation for internal and funded projects.
• Support compliance efforts, audits, and quality controls in a regulated (GMP/cGMP-like) setting for translational research.
• Develops and maintains instrumentation logs, databases, intellectual property, and inventories.

• Participate in device prototyping, manufacturing, assembly, and testing processes, ensuring adherence to protocols and controls.

• Collect, organize, and verify data generated from device testing, process qualification, and manufacturing runs.
• Compile and trend quality assurance data to identify process issues and support redesign efforts.
• Summarize results in technical reports and present findings to project teams, investigators, and sponsors

• Assist in expanding and maintaining the Quality Management System (QMS) infrastructure, including documentation, procedures, and compliance elements aligned with relevant regulations (e.g., 21 CFR parts relevant to devices or biologics, ICH guidelines).
• Support equipment installation, calibration, qualification (IQ/OQ/PQ), and validation activities for lab and manufacturing spaces.
• Contribute to facility operations, including setup, maintenance, and troubleshooting of equipment and controlled environments.
• Works on advanced problems in which analysis of situations or data requires an in-depth evaluation of various factors.
• Manufactures test kits, training modules, and instrumentation
• Designs engineering of both devices and consumables

• No direct supervisory responsibility for exempt or non-exempt staff.
• Train and provide day-to-day guidance to students, technicians, and lab users on equipment operation, procedures, and quality requirements.

Performs other duties as assigned.

• Master's degree in engineering (biomedical, mechanical, chemical, or related), biology, or a closely related scientific/technical field.
• 3+ years of hands‑on experience in a regulated laboratory or manufacturing environment, preferably involving GMP, GLP, or similar quality systems (e.g., medical device, biologics, or pharma settings).
• Practical experience with equipment qualification, process controls, manufacturing/testing of devices or biological products, and documentation (SOPs, protocols, reports).

• Strong technical aptitude, attention to detail, and ability to work in a controlled/cleanroom or lab environment.
• Excellent organizational and communication skills

• Experience in medtech, biotech, or regenerative engineering environments, including device prototyping, assembly, or testing.
• Prior work within a Quality Management System (QMS) environment or supporting tech transfer under documented…