POSITION SUMMARY:

We are seeking a proactive and hands-on Manufacturing Engineer with approximately 3–5 years of experience in a regulated manufacturing environment. This role is responsible for supporting production operations, troubleshooting on-floor issues, maintaining and improving tooling and fixtures, and contributing to continuous improvement initiatives. The ideal candidate will have a strong mechanical foundation, CAD proficiency, and a working knowledge of GMP/GDP practices, with exposure to structured problem-solving tools. Prior experience in medical devices or cleanroom environments is preferred.

REQUIRED QUALIFICATIONS:

• Bachelor’s degree in Mechanical, Manufacturing, or Industrial Engineering (or related discipline).
• 3–5 years of engineering experience in a manufacturing environment.
• Proficiency with CAD software (e.g., SolidWorks) for mechanical design and drafting.
• Working knowledge of GMP (Good Manufacturing Practices) and GDP (Good Documentation Practices).
• Exposure to lean manufacturing concepts and structured problem-solving methods (e.g., FMEA, DMAIC).
• Strong troubleshooting skills with a solution-oriented mindset.
• Excellent communication and interpersonal skills, with a collaborative and supportive working style.

PREFERRED QUALIFICATIONS:

• Experience in the medical device industry or other FDA-regulated manufacturing environment.
• Exposure to cleanroom operations, including gowning procedures and contamination control.
• Familiarity with quality system regulations such as 21 CFR Part 820 and ISO 13485.
• Basic knowledge of validation protocols (IQ/OQ/PQ) and design for manufacturability (DfMA).
• Experience supporting nonconformance investigations and CAPA implementation.

• Provide direct, daily engineering support to production including troubleshooting mechanical/process issues and implementing corrective actions.
• Design, improve, and maintain production fixtures, jigs, and tooling using CAD software (e.g., SolidWorks), ensuring functionality, safety, and ergonomic use.
• Participate in cross-functional problem-solving efforts using tools such as DMAIC, 5 Whys, and Fishbone analysis.
• Collaborate with production, quality, and R&D teams to drive continuous improvement and resolve nonconformances (e.g., NCRs, CAPAs).
• Support process changes, fixture validations, and documentation updates in compliance with GMP and GDP.
• Contribute to equipment and process validation activities (IQ/OQ/PQ) under guidance.
• Assist with line layout improvements, operator support, and workflow optimization.
• Maintain clear, accurate, and compliant technical documentation and work instructions.