Manufacturing Engineer II (Medical Devices)

Position Title: Engineer II, Manufacturing (Medical Devices)

Name of Department: Manufacturing Engineering

Position 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.

Key Accountabilities:

• 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)
• Complete investigation, improvements, and documentation of preventative and corrective actions (CAPAs)
• Utilize Lean Manufacturing principles in order to increase prouductivity / 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
• 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

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:

• Bachelor’s degree in engineering or equivalent experience
• 3+ 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

No sponsorship visa (H1-B, etc) candidates at this time, sorry.


Qualified candidates must submit their resume in Microsoft Word format along with at least three professional references to:


COYOTE TECHNICAL & EXECUTIVE SOURCING
Phil Montoya
Director of Sourcing