Sr. Process Engineer - Medical Device Industry

Work Location

Global (Likely Warsaw, IN)

# of requirements

1 Onsite

Duration (in Months)

12

Expected Salary

$90K/yr + benefits

Experience Required

4-8 yrs

Education

Bachelor's degree (Min.)

Job Title

Sr. Process Engineer

Must have skills*

• Minimum of Bachelor's degree in Mechanical Engineering or a related science/engineering degree is required
• A minimum of 4 years of manufacturing, quality or process engineering
• Strong understanding of process engineering
• Experience in reading and understanding drawings//part prints
• Experience in working with various functional teams in supplier organization
• Experience in process validations/verifications and PFMEA
• Experience in preparing, reviewing and approving technical documents
• Knowledge of Lean Engineering
• Prepared to travel up to 10% domestic and international

Good to have skills*

• Experience in CNC 5 Axis Machining
• Experience with Cleanliness, Sterilization, and/or Packaging
• Experience in regulated industry, FDA, ISO, etc.
• Certification in Six Sigma or Statistical Engineering

Key responsibilities*

• Develop project timelines and work breakdown structure
• collaboration across cross-functional resources to accomplish actions on-time or ahead of schedule
• Prioritize resource allocations across multiple projects
• Lead Product Transfers at Suppliers
• Set, track, and communicate metrics, goals, and objectives
• Execute Quality System requirements for Supplier Activities including: Change Orders/Supplier Change Request, PFMEA, engineering studies, verification/validation protocols and reports
• Support Quality Event Resolution
• Provide timely and accurate project status reporting and escalations to executive stakeholders
• Develop strategic alliances across functions, business units, and geographic boundaries to achieve effective outcomes over the long-term
• Evaluate and implement processes and programs to improve product quality, reduce cost at supplierEvaluate and implement processes and programs to improve product quality, reduce cost at supplier