• 05-Mar-2018 to 04-May-2018 (PST)
  • Process Engineering
  • Hillsboro, OR, USA
  • DOe
  • Salary
  • Full Time
  • Worksite - Cornelius Pass

Medical, Vision, Dental, 401(k) match, Paid Time Off, Floating Holidays, Discretionary Bonus Opportunity, Tuition Reimbursement, Summer Hours, Paid Parental Leave, and more!

Job Summary:
This role supports production cells and other teams to meet operational objectives by developing, integrating, and improving production processes and systems. The Process Engineer also ensures compliance to Acumed, FDA, and ISO regulations.

What will this position be responsible for?
• Develop and implement advanced production fixtures
• Develop new production Routes, Bill of Materials (BOMs), and Inspection Plans via ECOs
• Manage Quality Notification (QN) system and disposition all non-conforming product
• Support corrective/preventative action activities (CAR/SCAR)
• Prepare and analyze quality metrics to identify repeated quality issues
• Lead cell level Process Improvement (PI) initiatives and implement Lean tools
• Develop manufacturing plans and timelines for new product release
• Review new product design for manufacturability prior to production release
• Coordinate Pilot Production Runs and conduct production readiness reviews (PRR)
• Develop and execute Process Validation protocols and reports
• Implement and improve upon existing manufacturing processes

• 5+ years process engineering or related experience
• Applied 3D CAD experience in Autodesk Inventor, Solidworks, PRO-E or equivalent
• Applied understanding of Geometric Dimensioning & Tolerancing (GD&T)
• Applied understanding of Process Validation (IQ, OQ, & PQ) requirements
• Understanding of statistical tools such as control charts, trending, and capability
• Experience in the Medical Device industry desired
• Knowledge of FDA and ISO 13485 Regulations
• Understanding of Risk Management and experience with tools such as FMEA


Acumed is an equal opportunity employer. All qualified applicants will receive consideration for employ ment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, among other things, or status as a qualified individual with a disability.

As an equal opportunity employer, Acumed is committed to providing reasonable accommodations to applicants with disabilities. If you are interested in applying to Acumed and need special assistance or accommodation, please contact us at

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