Engineer - Intern

W2 Only

We are looking a highly motivated and detail-oriented Intern to support cross-functional activities spanning Engineering, Regulatory Affairs, Validation, and Manufacturing within the medical devices and pharmaceutical environment. This role offers hands-on exposure to product lifecycle development, quality systems, compliance frameworks, and production operations in a highly regulated industry.

The intern will collaborate with multidisciplinary teams to ensure products meet design specifications, regulatory requirements, and manufacturing standards while maintaining compliance with global health authority guidelines.

Key ResponsibilitiesEngineering Support

• Assist in product design, development, and improvement initiatives for medical devices or pharmaceutical systems.
• Support creation and maintenance of design documentation, including design inputs/outputs, risk analyses, and technical reports.
• Participate in root cause investigations and engineering change processes.
• Contribute to design verification and design validation activities.

Regulatory Affairs

• Support preparation and organization of regulatory submissions and documentation (e.g., technical files, device master records, dossiers).
• Assist in ensuring compliance with applicable regulations (e.g., FDA, EU MDR, ICH guidelines).
• Help maintain regulatory records and track submission timelines.
• Participate in audits and inspections by preparing supporting documentation.

Validation & Quality Assurance

• Assist in validation activities, including:
• Installation Qualification (IQ)
• Operational Qualification (OQ)
• Performance Qualification (PQ)
• Support development and execution of validation protocols and reports.
• Contribute to process validation, cleaning validation, and equipment qualification efforts.
• Participate in deviation investigations, CAPA (Corrective and Preventive Actions), and change control processes.

Manufacturing & Operations

• Support manufacturing process improvements and lean initiatives.
• Assist in developing and updating Standard Operating Procedures (SOPs) and batch records.
• Monitor production activities to ensure compliance with Good Manufacturing Practices (GMP).
• Help analyze production data for efficiency, yield, and quality trends.

Engineering & CAD Support

• Assist in product and component design using CAD tools (e.g., SolidWorks, AutoCAD, or similar).
• Create and update 2D drawings, 3D models, assemblies, and engineering change documentation.
• Support design reviews, tolerance analysis, and design for manufacturability (DFM).
• Maintain accurate design history files (DHF) and technical documentation.

HVAC & Controlled Environment Systems

• Support monitoring and documentation of HVAC systems used in cleanrooms and controlled environments.
• Assist in qualification and validation of HVAC systems (e.g., airflow, temperature, humidity, pressure differentials).
• Help ensure compliance with cleanroom classifications (e.g., ISO classes) and environmental monitoring programs.
• Participate in investigations related to environmental excursions and contamination control.

Cross-Functional Collaboration

• Work closely with Engineering, Quality, Regulatory, and Manufacturing teams to support integrated project goals.
• Participate in team meetings, project reviews, and continuous improvement initiatives.
• Communicate findings, progress, and recommendations effectively to stakeholders.

Learning & Development Opportunities

• Exposure to regulated product development lifecycle in medical devices and pharmaceuticals.
• Hands-on experience with quality systems and compliance frameworks (e.g., ISO 13485, GMP).
• Training in validation methodologies and regulatory submission processes.
• Opportunity to contribute to real-world projects impacting patient safety and product quality.

QualificationsEducation

• Currently pursuing a Bachelor’s or Master’s degree in:
• Engineering, Regulatory, Pharmaceutical Sciences, Life Sciences, Public Health, Informatics or a related field

Skills & Competencies

• Basic understanding of engineering principles and manufacturing processes.
• Familiarity with regulatory and quality concepts (preferred but not required).
• Strong analytical, problem-solving, and organizational skills.
• Excellent written and verbal communication abilities.
• Proficiency in Microsoft Office (Excel, Word, PowerPoint); knowledge of data analysis tools is a plus.

Pay: $25.00 - $50.00 per hour

Work Location: In person