Manufacturing Engineer

We are seeking a highly motivated Medical Device Engineer with 4–6 years of experience in the medical device industry to support product development, manufacturing, process improvements, and regulatory compliance. The ideal candidate will have hands‑on experience working in FDA-regulated environments, collaborating with cross‑functional teams, and driving engineering solutions throughout the product lifecycle.

• Design, develop, and support medical device products from concept through commercialization.
• Collaborate with R&D, Manufacturing, Quality, Regulatory Affairs, and Supply Chain teams to ensure successful product development.
• Develop and execute engineering protocols, design verification (DV), design validation (PV), and process validation activities (IQ/OQ/PQ).
• Prepare and maintain engineering documentation including design history files (DHF), device master records (DMR), BOMs, specifications, and technical reports.
• Support risk management activities in accordance with ISO 14971 including FMEA and hazard analysis.
• Investigate product and process issues using root cause analysis and implement effective CAPAs.
• Participate in Engineering Change Orders (ECO/ECN) and continuous improvement initiatives.
• Ensure compliance with FDA 21 CFR Part 820, ISO 13485, and applicable regulatory standards.
• Support manufacturing transfers, equipment qualifications, and new product introductions (NPI).
• Analyze manufacturing data and recommend process improvements to improve quality, efficiency, and yield.

• Bachelor's degree in Mechanical Engineering, Biomedical Engineering, Manufacturing Engineering, or a related engineering discipline.
• 4–6 years of engineering experience within the Medical Device industry.
• Strong knowledge of FDA Quality System Regulations (21 CFR Part 820), ISO 13485, and ISO 14971.
• Experience with Design Controls, Risk Management, CAPA, NCR, and Change Control.
• Hands‑on experience with Design Verification & Validation (DV&V), Process Validation (IQ/OQ/PQ), and Root Cause Analysis.
• Experience supporting product development and manufacturing in regulated environments.
• Proficiency with engineering drawings, GD&T, and CAD software (Solid Works, Creo, or AutoCAD).
• Excellent technical writing, documentation, and communication skills.