Metrology Engineer

Progressive Major Tasks & Responsibilities:

· Support / Maintain 5S practices and standards

· Perform Daily Gemba Walks

· Consistently demonstrate teamwork, collaboration, and respectful interactions

· Ensure all staff and contractors comply with applicable FDA 21 CFR 820, FDA GMP, and Raumedic Quality Management System (QMS) requirements

· Ensure all staff and contractors behave in a legal and ethical manner

· Achieve 100% QMS compliance for SAP based maintenance records and calibrations for all gage, fixture, and inspection software

· Generate and maintain engineering standards in SAP relative to inspection set-up times and run rates

· Learn, understand, and deploy basic Lean principles applicable to the usage, storage, maintenance, and calibration of gages, fixtures, and inspection software

· Generate and maintain Production Technician and QC staff inspection training content and materials; written, photographic, and video based

· Achieve COO approval on proposed Project Charters, Project Plan, and Return-on-Investment estimates for capital investments

· Track, report and achieve Project Plan milestones, project budget and operational improvements at prescribed cadence

· Track, report and achieve area budget as assigned

· Achieve and maintain relevant professional certifications (i.e. ASQ Certified Quality Engineer, ASQ Certified Calibration technician, etc.)

· Master and deploy all applicable Lean principles in inspection functions

· Effectively interact with R&D engineers in preparation for new product launches and transfers into production

· Effectively coach all Production Technicians and Quality staff in the proper set-up and use of gages, fixtures, and inspection software

· Lead 3 – 5 active Gage Repeatability and Reproducibility (GR&R) projects to achieve GR&R of 10% or less.

· Lead 3 - 5 active projects reducing the cost of inspection activities

· Create and submit capital spend budgets with appropriate analysis, selections, and cost justifications

· Actively participate in all facility utilization activities providing macro and micro layout options for all inspection activities

· Achieve additional relevant professional certifications

· Demonstrated knowledge and effective application of six sigma problem solving techniques

· Effectively interact with R&D engineers influencing design for manufacturability decisions

· Demonstrated knowledge of process validation

· Effectively coach all Level 1, Level 2 and Level 3 Production Technicians, Quality staff and Manufacturing Engineers

· Track, report and achieve Project Plan milestones, project budget and operational improvements at prescribed cadence

· Effectively participate with COO and CFO on capital expense plans and approvals

· Effectively participate with COO and CFO on facility planning, utilization and macro layout options

Minimum Qualifications:

· Bachelor’s degree in engineering, materials, or related field of study and/or equivalent professional experience (Level dependent)

· Two to five years’ experience in a manufacturing environment, medical device experience preferred (Level dependent)

· Working knowledge of applicable FDA and ASQ standards and requirements.

· The ability to work flexibly including working non-standard hours

Job Type: Full-time

Pay: $75,000.00 - $100,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Employee assistance program
• Employee discount
• Flexible spending account
• Health insurance
• Life insurance
• Paid time off
• Referral program
• Tuition reimbursement
• Vision insurance