Manufacturing Engineer 2

Full-time - Entry Level

Hillsboro, OR

10,001+ employees

About the position

The Manufacturing Engineer (ME) supports Acumed’s medical device life cycle, ensuring efficient production and new product development. This role focuses on process integration, validation, and continuous improvement through waste reduction and advanced manufacturing methods. The ME is accountable for Cost of Goods Sold (COGS), On-Time Delivery (OTD), and New Product Introduction (NPI) targets while maintaining compliance with Good Manufacturing Practices (GMPs). The ideal candidate is passionate about manufacturing, thrives in a regulated environment, and excels in technical writing, problem-solving, and shop floor collaboration.

Responsibilities

• Design, develop, and implement advanced production fixtures.
• Create and optimize production routings, In-Process Inspections (IPI), and Bills of Materials (BOMs).
• Support corrective and preventative action activities (CAR/SCAR).
• Utilize statistical methods to ensure process capability and controls.
• Analyze operational metrics to identify trends and improvement areas.
• Lead process improvement initiatives and apply lean manufacturing tools.
• Develop manufacturing plans and timelines for new product releases.
• Review product designs for manufacturability before production.
• Coordinate Process Development Runs and Production Readiness Reviews (PRR).
• Develop and execute Process Validation protocols and reports.
• Enhance and refine existing manufacturing processes.
• Collaborate effectively with cross-functional teams and vendors.

Requirements

• B.S. in Engineering (Mechanical, Manufacturing, Industrial) or equivalent.
• Basic 3D CAD experience (PTC Creo, Autodesk Inventor, SolidWorks, etc.).
• Skilled in data-driven problem-solving and root cause analysis.
• Strong communication skills (verbal and written).
• Team-oriented with experience in CNC machining or other manufacturing processes.
• 2+ years of manufacturing engineering or related experience.

Nice-to-haves

• Medical device experience, FDA & ISO 13485 knowledge.
• Applied 3D CAD experience and understanding of GD&T.
• Familiarity with Process Validation (IQ, OQ, PQ) and statistical tools (Minitab, JMP, etc.).
• Knowledge of risk management (FMEA), CNC programming, and shop floor inspection methods.