Intellectt Inc is hiring: Manufacturing Engineer in New York

Medical Devices | pharma | Bio Technology

Job Title: Manufacturing Engineer

Location: NY

Duration: 12 Months

Position Overview

We are seeking a skilled and motivated Manufacturing Engineer with a minimum of 3 years of hands‑on experience in the medical device industry. The ideal candidate will play a key role in supporting manufacturing operations, process improvement, and product quality within a regulated environment. This position offers an excellent opportunity to contribute to the production of life‑saving medical technologies while ensuring compliance with industry standards and regulatory requirements.

Key Responsibilities

• Develop, implement, and optimize manufacturing processes to improve product quality, efficiency, and throughput.
• Collaborate with cross‑functional teams including R&D, Quality, Regulatory, and Production to support product transfer from design to manufacturing.
• Provide technical support for process validation (IQ/OQ/PQ), equipment qualification, and change control activities.
• Conduct root cause analysis and implement corrective and preventive actions (CAPA) for process or product nonconformances.
• Ensure all processes comply with FDA, ISO 13485, and GMP standards.
• Prepare and maintain detailed engineering documentation, including work instructions, validation protocols, and test reports.
• Support continuous improvement initiatives using Lean Manufacturing and Six Sigma methodologies.
• Evaluate and implement new equipment, tools, and technologies to enhance manufacturing capabilities.
• Participate in risk assessments (pFMEA, dFMEA) and contribute to design‑for‑manufacturability reviews.

Qualifications

• Education: Bachelor’s degree in Mechanical, Manufacturing, Biomedical, or Industrial Engineering (or related field).
• Experience: Minimum 3+ years of manufacturing engineering experience in the medical device industry or a similar regulated environment.
• Strong knowledge of FDA QSR, ISO 13485, and Good Manufacturing Practices (GMP).
• Experience with validation, process characterization, and equipment qualification.
• Proficiency in CAD tools, MS Office, and familiarity with ERP/MES systems.
• Strong analytical, documentation, and problem‑solving skills.
• Excellent communication and teamwork abilities.

Preferred Skills

• Experience with automation or process improvement projects in medical device manufacturing.
• Working knowledge of Lean Six Sigma methodologies and statistical analysis tools (Minitab, JMP).
• Familiarity with cleanroom environments and assembly of Class II or Class III medical devices.

Seniority Level

Mid‑Senior level

Employment Type

Contract

Job Function

Other

Industries

Medical Equipment Manufacturing, Pharmaceutical Manufacturing, and Biotechnology Research

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