Job Description

Position Overview:
We are seeking a dedicated and detail-oriented Entry-Level Manufacturing Engineer to join our team in the medical device domain. This role involves supporting the manufacturing process, ensuring compliance with regulatory standards, and collaborating with cross-functional teams to optimize production efficiency. The ideal candidate will have a strong engineering foundation, a keen interest in medical devices, and a commitment to quality and innovation.

Key Responsibilities:

Manufacturing Support:

• Assist in developing and optimizing manufacturing processes for medical devices, ensuring efficiency, quality, and cost-effectiveness.
• Collaborate with design, quality, and production teams to implement process improvements.

Documentation and Compliance:

• Create and maintain manufacturing documentation, including work instructions, process validation protocols, and engineering change orders (ECOs).
• Ensure compliance with ISO 13485, FDA regulations, and other applicable standards.

Process Validation:

• Support validation activities, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
• Assist in conducting root cause analysis and implementing corrective actions for nonconformities.

Equipment and Tools:

• Work with manufacturing equipment and tools, ensuring they are properly maintained and calibrated.
• Assist in troubleshooting equipment issues to minimize downtime.

Quality Assurance:

• Collaborate with the quality team to address deviations, perform risk assessments, and ensure product reliability.
• Support CAPA (Corrective and Preventive Action) investigations and participate in internal audits.

Continuous Improvement:

• Participate in Lean, Six Sigma, and other process improvement initiatives to enhance operational performance.
• Contribute to cost reduction, waste minimization, and yield improvement efforts.

Qualifications:

Education:
Bachelor's degree in Mechanical, Biomedical, Industrial Engineering, or a related field.

Skills:

• Basic knowledge of manufacturing processes (e.g., injection molding, soldering, assembly).
• Familiarity with engineering drawings, blueprints, and GD&T (Geometric Dimensioning and Tolerancing).
• Proficiency in CAD software (e.g., SolidWorks, AutoCAD) and Microsoft Office Suite.
• Understanding of medical device standards (ISO 13485, FDA 21 CFR Part 820).
• Strong analytical, problem-solving, and organizational skills.

Experience:

• Internships or academic projects in manufacturing or medical devices are a plus.
• Hands-on experience with manufacturing equipment and tools is desirable.

Preferred Qualifications:

• Knowledge of validation and testing protocols for medical devices.
• Familiarity with risk management processes (ISO 14971).
• Exposure to statistical analysis tools (e.g., Minitab, JMP).

Work Environment:

• This position requires working in a cleanroom environment, adhering to strict hygiene and safety protocols.
• May involve occasional travel to suppliers or other manufacturing sites.

Why Join Us?

• Opportunity to contribute to the development of life-saving medical devices.
• Collaborative and innovative work culture with mentorship opportunities.
• Competitive salary and benefits package.
• Apply today to launch your career in manufacturing engineering and make a difference in the medical device industry!

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