Acumed
  • 07-Nov-2018 to 06-Jan-2019 (PST)
  • Process Engineering
  • Hillsboro, OR, USA
  • DOE
  • Salary
  • Full Time
  • Worksite - Cornelius Pass

Medical, Vision, Dental, Paid Parental Leave, 401(k) match, Paid Time Off, Fitness Reimbursement, Costco Membership Sponsorship, Tri-Met pass and more!


About Us

Acumed is a global leader of innovative orthopaedic and medical solutions developed to improve patient care. With over three decades of experience in the orthopaedic industry, our mission is to aid the afflicted through the ingenuity of our minds, the labor of our hands and the compassion of our hearts. The company is headquartered in Hillsboro, Oregon with a global sales and distribution network supported by offices worldwide.

Process Engineer II

The Process Engineer (PE) is responsible for meeting operational objectives in production and new product development by developing, integrating, and improving production processes and systems. The PE owns continuous improvement of processes by improving methods and developing new methods of manufacturing, leading to increased yields and reduced labor content. Conceives, evaluates and implements problem solving activities, cost reduction initiatives and part/process improvement activities. The Process Engineer ensures manufacturing processes are in compliance with Acumed, FDA, and ISO regulations.

Duties/Responsibilities

• Develops, designs, and implements advanced production fixtures
• Develops and implements new production Routings, In Process Inspection (IPI) and Bills of Material (BOMs)
• Supports corrective/preventative action activities (CAR/SCAR)
• Prepares and analyzes quality metrics to identify repeated quality issues
• Leads cell level Process Improvement (Pi) initiatives and implement lean tools
• Develops manufacturing plans and timelines for new product release
• Reviews new product design for manufacturability prior to production release
• Coordinates Pilot Production Runs and conducts Production Readiness Reviews (PRR)
• Develops and executes Process Validation protocols and reports
• Implements and improves upon existing manufacturing processes

Qualifications

• B.S. Degree in Engineering (Mechanical, Manufacturing, Industrial) or equivalent
• 2+ years process engineering or related experience
• Applied 3D CAD experience in Autodesk Inventor, Solidworks, PRO-E or equivalent
• Basic understanding of Geometric Dimensioning & Tolerancing (GD&T)
• Basic 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 and ACUTE are equal opportunity employers. All qualified applicants will receive consideration for employment 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 recruiting@acumed.net.

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