Acumed
  • 06-Aug-2020 to Until Filled (PST)
  • Process Engineering
  • Hillsboro, OR, USA
  • DOE
  • Salary
  • Full Time
  • Worksite - Cornelius Pass

Medical, Vision, Dental, 401(k) match, Paid Parental Leave, Paid Time Off, Floating Holidays, Tuition Reimbursement Program, TriMet Pass, Costco Membership 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 III

The Process Engineer (PE) is responsible for supporting the life cycle of Acumed medical devices by meeting operational objectives in production and new product development. This includes developing, integrating, validating and improving production processes and systems. The PE owns continuous improvement of existing processes through the elimination of waste and / or the adoption of new methods of manufacturing. The Process Engineer is a co-owner of Acumed's Cost of Goods Sold (COGS), On Time Delivery (OTD), and New Product Introduction (NPI) targets. The Process Engineer supports Acumed's quality-first culture by ensuring Acumed processes are aligned to regulated Good Manufacturing Practices (GMPs). There are two key process groups that the process engineering team supports; one groups can be categorized into machining and finishing processes and the other group as wet processing and packaging. With the exception of an entry-level process engineer, qualifications to support either group are different. Those specialized qualifications can be found in the qualifications section of the job description. All current process engineering job openings should define the process group that will be supported.

The ideal candidate has a passion for manufacturing and can be effective in a quality-first, highly regulated environment. The Process Engineer must have excellent verbal communication and technical writing skillset with demonstrated experience using analytical methods to solve problems. The Process Engineer must have a "go and see" mentality and feel comfortable in a shop floor environment.

Duties/Responsibilities

  • 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
  • Provides manufacturing engineering expertise with specific emphasis on achieving: DFM/A-Design for Manufacturability / Assembly and high product Quality through detailed process characterization, process documentations, equipment, tools, fixtures, jigs, and qualification.
  • Manages all manufacturing details of new product launches
  • Develops and implements advanced inspection methods and gaging
  • Manages corrective/preventative actions (CAR/SCAR)
  • Evaluates inspection frequency considering risk management and process capability
  • Uses appropriate statistical techniques to develop validation protocols, complete process capability studies and process validation on processes.
  • Actively participate in other team activities to help insure total team success.
  • Leads system level Process Improvement (Pi) initiatives and implements Lean tools
  • Reviews and approves Process Validation protocols and reports
  • Prepares new equipment proposals including ROI justification
  • Manages technical operational projects
  • Leads cross-functional groups
  • Communicates effectively with all levels of the organization

Qualifications

  • B.S. Degree in Engineering (Mechanical, Manufacturing, Industrial)
  • 5+ years process engineering or related experience
  • Advanced 3D CAD experience in Autodesk Inventor, Solidworks, PRO-E or equivalent
  • Applied understanding of Geometric Dimensioning and Tolerancing (GD&T)
  • Applied understanding of machining capabilities, CNC programming
  • Selection and commissioning of new production equipment
  • Applied experience with of Process Validation (IQ, OQ, and PQ) requirements
  • Applied experience with statistical tools such as control charts, trending, and capability with Minitab, JMP or equivalent. 
  • Subject matter expert (SME) / key liaison of CNC machining capabilities
  • Applied experience of shop floor inspection methods
  • Applied experience of removing manufacturing constraints and improving process flow.

Acumed is an equal opportunity employer. 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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