Senior Manufacturing Engineer

Acumed • Hillsboro, OR

106d

About The Position

The Senior Manufacturing Engineer (SME) supports the life cycle of Acumed medical devices, driving process development, integration, validation, and continuous improvement. This role ensures operational objectives in COGS, OTD, and NPI while maintaining GMP compliance. The SME eliminates waste, optimizes processes, and enhances manufacturing efficiency. The ideal candidate is passionate about manufacturing and machining, thrives in a regulated, quality-first environment, and excels in technical writing, problem-solving, and shop floor collaboration. This role also involves mentorship, technical leadership, and strategic planning.

Requirements

• B.S. in Engineering (Mechanical, Manufacturing, Industrial) or equivalent.
• 5+ years of manufacturing engineering or related experience.
• Advanced 3D CAD experience (Autodesk Inventor, SolidWorks, PRO-E, etc.).
• Strong understanding of GD&T, CNC programming, and machining capabilities.
• Experience with ROI analysis, capital equipment selection, and process validation.
• Knowledge of FDA and ISO 13485 regulations.
• Experience with statistical tools (Minitab, JMP, etc.).

Responsibilities

• Develop, integrate, and validate production processes.
• Lead new product launches and process validation (IQ, OQ, PQ).
• Apply DFM/A principles to optimize manufacturability and product quality.
• Implement Lean tools and lead process improvement initiatives.
• Manage corrective/preventative actions (CAR/SCAR) and risk-based inspection strategies.
• Utilize statistical analysis tools (Minitab, JMP, etc.) for process capability and validation.
• Evaluate and justify capital equipment purchases (ROI analysis).
• Oversee selection and commissioning of new production equipment.
• Serve as SME for machining and wet processing/packaging processes.
• Act as a key liaison for audits and cross-functional initiatives.
• Communicate effectively across all organizational levels.
• SME & key liaison for machining capabilities.
• Applied experience in shop floor inspection methods.
• Expertise in removing manufacturing constraints and improving process flow.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Industry: Miscellaneous Manufacturing
• Education Level: Bachelor's degree