Sr. Manufacturing Engineer (Medical Device)

Performs process, tool, and gauge development and implementation activities, implement cost reductions, develop process layouts, develop and maintain manufacturing instructions and device history records, and execute process validation protocols, builds and reports.

Key Accountabilities:

• Work with engineering director to determine projects and related tasks
• Manage and lead projects and tasks
• Refine manufacturing processes and flow
• Develop new processes that increase productivity and reduce cost
• Implement cost reductions via materials or manufacturing time
• Investigate and provide engineering support to Manufacturing processes, SPC, and non-conforming material (NCR)
• Prepare, analyze, and present data at monthly NCR and Management Review meetings (if applicable)
• Complete investigation, improvements, and documentation of preventative and corrective actions (CAPAs)
• Manage Tooling System including preventive maintenance, calibrations, and equipment records (if applicable) • Manage duties of manufacturing technician, including workload and personal issues (if applicable)
• Utilize Lean Manufacturing principles in order to increase productivity / throughput, reduce cost, and /or eliminate waste
• Implement new processes and issue process validation protocols and reports
• Develop, document (using AutoCad / SolidWorks), and implement fixtures, jigs, tools, and gauges
• Document methods for manufacturing and inspection (Manufacturing Instructions)
• Work with Research and Development and Process Development to develop and transfer new designs to manufacturing (lead and manage design transfer projects)
• Initiate process, design, and documentation changes through the change management process
• Utilize statistics to evaluate, justify, and support experiments, analysis, and validations • Log engineering evaluations into Engineering Notebooks
• Perform tooling verifications and carry out TMV/CSV/IQ/OQ/PQ activities
• Perform Root Cause Investigations, develop and implement solutions
• Perform process development and execute DOE’s (Design of Experiments)
• Work with Mfg Supervisor to analyze Manufacturing data and lead improvement projects that come from this analysis

Qualifications

• Minimum Skills and Capabilities:
• Excellent written and verbal communication skills
• Proficient in software applications
• Ability to organize and conduct experiments independently
• Ability to analyze and solve technical problems
• Hands on abilities to engineer tooling, processes, and equipment
• Hands on experience building prototypes, tooling, and fixtures
• If acting as Laser Safety Office (LSO) - Certification of Laser & X-ray safety
• Minimum Knowledge & Experience required for the position:
• 4 - year engineering degree or equivalent experience
• 7+ years of experience in an engineering role in the medical device industry
• Project management experience in the medical device industry
• Hands-on knowledge of electronics, motion control, plastics, metrology, metallurgy, and manufacturing processes
• Experience with polymers, medical grade metals, manufacturing equipment, and medical packaging