Advanced Manufacturing Engineer

Job Description

Job Title: Advanced Manufacturing Engineer Medical Device New Product Development (NPD) Experience: 10+ years Industry: Medical Devices Job Summary We are seeking a seasoned Advanced Manufacturing Engineer (AME) to lead the integration of manufacturing processes into the development of innovative medical devices. This role focuses on optimizing production scalability, ensuring regulatory compliance, and driving continuous improvement in new product development (NPD) and R&D initiatives. The ideal candidate will have a proven track record in medical device manufacturing, process validation, and cross-functional collaboration. Key Responsibilities 1. Process Improvement & Optimization Identify and implement Lean/Six Sigma methodologies to reduce waste, improve efficiency, and enhance product quality. Conduct statistical process control (SPC) and root cause analysis (RCA) for manufacturing deviations. 2. Equipment & Process Validation Design and validate manufacturing equipment/tooling (IQ/OQ/PQ) to meet Medical Device Regulatory Standards. Develop and maintain SOPs, PFMEAs, and control plans. Lead fixture/tooling design and qualification (GR&R, MSA, capability studies). 3. New Product Development Support Collaborate with design teams to ensure manufacturability (DFMA) and compliance with regulatory requirements. Develop end-of-line testing protocols and commercialization strategies for surgical instruments and devices. Manage supplier selection, capital budgeting, and timelines for NPD launches. 4. Quality Assurance & Compliance Ensure adherence to ISO 13485, FDA 21 CFR Part 820, and EU-MDR requirements. Support CAPA investigations and gage R&R studies. Maintain documentation for audits, including design controls and validation reports. 5. Cross-Functional Collaboration Act as a liaison between R&D, engineering, quality assurance, and suppliers to resolve technical challenges. 6. Vendor & Supply Chain Coordination Evaluate and qualify new suppliers for scalability and compliance. Requirements Education: Bachelor’s / Master’s degree in Electronics / Mechanical / Production / Manufacturing, or Industrial Engineering. Experience: 10+ years in medical device manufacturing engineering, with expertise in NPD/R&D. Proficiency in CAD software (SolidWorks, Creo) and GD&T principles. Certifications (Preferred): ASQ Certified Quality Engineer (CQE), PMP, or Lean Six Sigma Black Belt. Must have Technical Skills: Advanced knowledge of process validation (IQ/OQ/PQ), PFMEA, and control plans, Gauge R&R and Vendor Qualification. Soft Skills: Strong problem-solving, communication, and project management abilities. Ability to travel up to 30%. Preferred Background Experience with electromechanical medical devices (e.g., Surgical consumables, OT Devices, etc).