Sr Manufacturing Engineer

Manufacturing Engineer is responsible for providing daily support of multiple product families with specific regard to product quality, product cost, process development and process improvements, safety, and project management activities relating to the assembly and packaging of suture products. Duties include managing and/or participating in cross functional teams to provide daily Manufacturing Engineering support of Automated, Manual assembly processes and project specific goals.

• * Team with manufacturing and quality personnel on a daily basis to review / disposition production defects and provide potential process and/or equipment corrective actions to assure production schedules and quality expectations are met.
• * Provide daily production support to set up, trouble shoot, repair, and monitor automated manufacturing assembly equipment.
• * Review manufacturing equipment and processes for improvement potential using statistical data and analysis of equipment condition then effectively manage change projects.
• * Lead Process improvement projects related to existing manufacturing processes.
• * Mechanical Aptitude and reverse Engineering of Mechanical Fixtures
• * Prepare IQ, OQ, PQ validation protocols and reports to support implementation of new, existing, and upgrading equipment.
• * Lead contributor in cross functional team work to investigate, analyze, and establish Corrective & Preventative Actions in support of Automated & Manual Assembly processes.
• * Support new process development, product quality improvement, and integration projects.
• * Maintain excellent communications with Manufacturing, Quality, Maintenance, Safety, Planning, and Metrology departments on an as needed basis.
• Prepare FAT, IQ, OQ, PQ validation protocols and reports to support implementation of new, existing, and upgrading equipment.
• Provide daily production support to set up, trouble shoot, repair, and monitor automated manufacturing assembly equipment.
• Perform process and equipment root cause investigations utlizing 6M, 5Y root cause investigation tools, and summarize findings, recommendation in CAPA/NCR reports.
• Scope and develop capital plans to improve equipment and monitor process Overall Equipment Efficiency (OEE) to provide improvements.

Education Required:

Bachelors in Mechanical Engineering, Electromechanical, Mechatronics, Electrical/Controls Engineering

Years’ Experience Required:

* 3-5 yrs. Applicable Experience.

TECHNICAL SKILLS

Must Have

• 1. Experience in equipment IQ
• 2. Experience in OQ (Operational Qualification) and PQ (Performance Qualification) and/or process validation
• 3. Process Validation Lifecylce ( from process characterization, operational qualification to performance qualification)
• 4. Preferred experience in DOE (with minitab)
• Other skills: 1. Computer and software validation CSV 2. SOP Development 3. Change control of Medical Devices 4.
• custom equipment validation experience

Nice To Have

• 1-3 years of Medical Device industry experience,
• Familiar with FDA 21 CFR Part 820, EU 217/745 (EU MDR),
• Familiar with these standards: ISO 13485, ISO 14971, IEC 60601,
• Knowledge of Microsoft Office Applications (Word, Excel, Access, and PowerPoint) and Windows OS.
• Absorbable and non-absorbable sutures and their applications
• Additional Medical Device experience
• Packaging Equipment