Job Summary We are seeking an experienced Manufacturing Engineer with a strong background in the Medical Device industry to support manufacturing process development, validation, optimization, and continuous improvement initiatives. The ideal candidate will have hands-on experience developing and optimizing manufacturing processes, executing IQ/OQ/PQ process validations, troubleshooting production and equipment issues, and supporting quality and regulatory requirements.
Roles & Responsibilities - Develop, characterize, optimize, and implement manufacturing processes and technologies for medical device production.
- Plan and execute process validation activities, including IQ, OQ, and PQ.
- Develop and maintain process validation protocols, reports, and supporting documentation.
- Perform PFMEA/FMEA activities to identify and mitigate manufacturing process risks.
- pply Lean Manufacturing and Continuous Improvement methodologies to improve process efficiency, quality, productivity, and cost.
- nalyze manufacturing data and process performance using Minitab and other statistical/data-analysis tools.
- Conduct Root Cause Analysis (RCA) and implement effective corrective and preventive actions.
- Support production troubleshooting and resolve manufacturing process and equipment-related issues.
- Develop and optimize manufacturing processes, tooling, fixtures, and equipment.
- pply Design for Manufacturability (DFM) principles when evaluating new products, processes, tooling, and design alternatives.
- Collaborate with Design Engineering and R&D teams to ensure products are manufacturable and production ready.
- Support equipment qualification, installation, and implementation activities.
- Identify opportunities to improve process capability, yield, throughput, reliability, and overall manufacturing performance.
- Prepare and maintain engineering documentation, work instructions, process specifications, and validation records.
- Work closely with Quality Engineering to ensure compliance with applicable quality and regulatory requirements.
- Support investigations, nonconformances, CAPA activities, and process improvement initiatives as required.
- Ensure manufacturing processes comply with applicable FDA regulations, ISO 13485, GMP, and company quality-system requirements.
- Provide technical support to production teams and assist with implementation of process improvements.
- Communicate effectively with cross-functional teams and manage multiple engineering projects and priorities.
Education & Experience - Bachelor's degree in mechanical engineering, Manufacturing Engineering, Industrial Engineering, or a related engineering discipline.
- dvanced degree or additional technical certifications in manufacturing, quality, or engineering is a plus.
- 3-4+ years of experience in Manufacturing Engineering, preferably within the Medical Device industry.
- Hands-on experience with manufacturing process development, characterization, optimization, and implementation.
