Manufacturing Engineer II

Job Overview

Supports the commercialized production of medical devices. Works within manufacturing engineering functions to provide technical support for the quality of the product, process development, continuous improvement, and process control.

Job Responsibilities and Essential Duties

• Works in team setting and works independently with minimal oversight.
• Supports production / manufacturing.
• Supports / Leads scrap reduction / equipment downtime reduction, and Lean efforts.
• Developed manufacturing methods into work instructions and associated training for transfer into production.
• Develops required maintenance and calibration instructions for manufacturing equipment and creates required equipment documentation.
• Provides higher level assistance for equipment design for producing medical devices and components.
• Perform process development and validation including IQ, OQ, PQ, EAT, & TMV.
• Perform process improvement initiatives.
• Supports / Leads non-conformance investigations, CAPA activity, OOT's, Customer complaints, PFMECA's, MES, and equipment troubleshooting.
• Executes complex change orders (ECO's) related to process and equipment documentation.
• Analyzes and documents test results for development and pilot production runs.
• Generates and manages PSO's.
• Specifies and executes equipment and tooling verifications and equipment acceptance tests. Contributes to the team effort by accomplishing related tasks as necessary.
• Support business metrics.
• Participate / Lead large scale projects.
• Protocol and report writing.
• Identify, Lead, and Resolve component / supplier related problems.
• Perform other related duties as required.
• Performs data analysis / root cause investigations with data driven approach.

Minimum Requirements

• Bachelor's Degree in Engineering, or equivalent work experience.
• Three years related manufacturing experience (medical device field is preferred).
• Must be highly skilled in equipment troubleshooting (Electro-mechanical)
• Must possess good problem solving skills and data analysis skillset.
• Demonstrated knowledge of MS Office applications (Word/Excel/PPT) is required (Minitab experience is preferred).

Required Knowledge, Skills and Abilities

• A demonstrated knowledge and understanding of Quality Assurance Methods and good analytical and problem solving skills are required.
• Good analytical and problem solving skills.
• The ability to organize, prioritize and adapt.
• Multi-tasking capabilities in a fast paced environment.
• Experience working with FDA requirements preferred.
• Experience working within a medical manufacturing environment preferred.
• Working knowledge of statistical process control and lean manufacturing preferred.
• Working knowledge of computer aided drawings (CAD / solid works) preferred.
• Excellent communication skills (oral and written)

Supervision/Management Of Others:

• Potentially

Internal and External Contacts/Relationships

• Main contacts, internal:
  
  
  
  • Manufacturing Engineering Staff
  • Operations Management and Staff
  • Maintenance / Calibration Staff
  • Quality Engineering / QC Staff
  • Product Sustaining Engineering Staff
  • R&D Staff
  
  
  
  
• Main contacts, external:
  
  
  
  • Product suppliers
  • Equipment / tooling suppliers
  
  
  
  

Environmental/Safety/Physical Work Conditions

• Most duties are performed in an office/workshop environment.
• Personal Protective Equipment may be required as dictated by environment (e.g. safety glasses).
• Frequent tasks are performed in an ISO Class 8, 7 & 5 cleanrooms. Must be able to gown up and perform tasks in a controlled environment.
• Physical requirements such as lifting items under 50 pounds and light assembly work may be required occasionally.
• Travel is typically not required for this position but may occur.

The physical demands described here are a representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Salary Range: $80K - $100K Annually DOE