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 III
The Process Engineer (PE) supports production cells and new product development 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.
Develop manufacturing process instructions and documentation
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
Develop and implement advanced inspection methods and gaging
Manage and approve corrective/preventative actions (CAR/SCAR)
Evaluate inspection frequency considering risk management and process capability
Implement Statistical Process Control (SPC) methods and tools use to determine root cause of failures and make recommendations in process changes.
Lead system level Process Improvement (PI) initiatives & implement Lean tools
Manage all manufacturing details of new product launches
Review and Approve Process Validation protocols and reports
Prepare new equipment proposals including ROI justification
Lead cross-functional groups
Communicate effectively with management
Manage multiple projects with limited supervision
B.S. Degree in Engineering (Mechanical, Manufacturing, Industrial) or equivalent
5+ years process engineering or related experience
Advanced 3D CAD experience in Autodesk Inventor, Solidworks, PRO-E or equivalent
Applied understanding of Geometric Dimensioning & Tolerancing (GD&T)
Applied experience with of Process Validation (IQ, OQ, & PQ) requirements
Applied experience with statistical tools such as control charts, trending, and capability
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 firstname.lastname@example.org.