Device Manufacturing Engineer

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

Job Summary:

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.

Please note:

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

Specific Responsibilities:

Administration

• 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.

Collaboration/Strategy

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

Data Analysis

• 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

Technical

• 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

Supervision

• 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.

Miscellaneous

Performs other duties as assigned.

Minimum Qualifications:

• 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).

Minimum Competencies: (Skills, knowledge, and abilities.)

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

Preferred Qualifications:

• 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 quality system processes (e.g., ISO 13485 or equivalent).

Preferred Competencies: (Skills, knowledge, and abilities)

• Familiarity with translational research, quality systems in academic or industry settings, and regulatory requirements for pre-clinical or early-phase manufacturing.
• Knowledge of project management tools or tracking milestones in technical projects.

Target hiring range for this position will be between $85,000-$105,000 per year. Offered salary will be determined by the applicant's education, experience, knowledge, skills and abilities, as well as internal equity and alignment with market data

Benefits:

At Northwestern, we are proud to provide meaningful and competitive benefits. The available benefits package for this position will include health, dental, vision, disability, and life insurance; paid vacation and holidays; paid medical/sick and parental leave; tuition benefits for the employee and dependents; pre-tax and flex spending accounts for commuting and dependent care; generous retirement savings options; and wellness programs. For a comprehensive overview of available benefits, including eligibility details, visit us at https://www.northwestern.edu/hr/benefits/index.html to learn more.

Work-Life and Wellness:
Northwestern offers comprehensive programs and services to help you and your family navigate life's challenges and opportunities, and adopt and maintain healthy lifestyles.
We support flexible work arrangements where possible and programs to help you locate and pay for quality, affordable childcare and senior/adult care. Visit us at https://www.northwestern.edu/hr/benefits/work-life/index.html to learn more.

Professional Growth & Development:
Northwestern supports employee career development in all circumstances whether your workspace is on campus or at home. If you're interested in developing your professional potential or continuing your formal education, we offer a variety of tools and resources. Visit us at https://www.northwestern.edu/hr/learning/index.html to learn more.

Northwestern University is an Equal Opportunity Employer and does not discriminate on the basis of protected characteristics, including disability and veteran status. View Northwestern's non-discrimination statement. Job applicants who wish to request an accommodation in the application or hiring process should contact the Office of Civil Rights and Title IX Compliance. View additional information on the accommodations process.

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