Manufacturing Engineer II (TAS)

Job Summary

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.

Job Details/Responsibilities

• Work with engineering director to determine projects and related 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)
• Manage Tooling System including preventive maintenance, calibrations, and equipment records (if applicable)
• Manage duties of engineer/technician/intern, including workload and personal issues (if applicable)
• Complete investigation, improvements, and documentation of preventative and corrective actions (CAPAs)
• Utilize Lean Manufacturing principles 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 gages.
• 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 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.

Job Responsibilities (continued)

Working Conditions/Physical Requirements

Quality Requirements:

• Maintain awareness of the relevance and importance of activities performed and how they contribute to the achievement of quality objectives.

• Work within the QMS always, ensure accurate completion of records and highlight issues to immediate supervisor any issues affecting quality.

• Responsible to ensure facility, processes and documentation always remain in a state of audit readiness.

EH&S requirements:

• Take care of your own health and safety and that of others who may be affected by your actions.
• Work co-operatively to highlight issues affecting Environmental Health and Safety

Knowledge, Skills and Abilities (KSA)

• 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

Qualifications/ Background Experiences

• Bachelor’s degree in engineering or equivalent experience
• 5+ years of experience in a technical role in the medical device industry
• Project management experience in the medical device industry
• Hands-on knowledge of electronics, motion control, plastics, metallurgy, and manufacturing processes
• Experience with polymers, medical grade metals and medical packaging