Senior Manufacturing Engineer

The Marmon Group; Hillsboro (OR); On-site; USD 85,000 - 110,000; Full time

Job summary

A leading company in the medical device industry is seeking a Senior Manufacturing Engineer to enhance production efficiency and ensure compliance with regulations. The ideal candidate will have a robust engineering background with extensive experience in manufacturing processes and CNC machining, demonstrating leadership in a regulated environment.

Qualifications

• 5+ years of manufacturing engineering or related experience.
• Advanced experience and knowledge in CNC machining.
• Strong understanding of GD&T and FDA/ISO 13485 regulations.

Responsibilities

• Develop, integrate, and validate production processes.
• Lead new product launches and process validation.
• Manage corrective/preventative actions and risk-based inspection strategies.

Skills

Technical writing

Problem-solving

Shop floor collaboration

Lean tools

Statistical analysis

Education

B.S. in Engineering (Mechanical, Manufacturing, Industrial) or equivalent

Tools

3D CAD (Autodesk Inventor, SolidWorks, PRO-E)

Statistical tools (Minitab, JMP)

Job description

Acumed LLC

As a part of the global industrial organization Marmon Holdings-which is backed by Berkshire Hathaway- you'll be doing things that matter, leading at every level, and winning a better way. We're committed to making a positive impact on the world, providing you with diverse learning and working opportunities, and fostering a culture where everyone's empowered to be their best.

Job Scope

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.

Duties & Responsibilities

• Develop, integrate, and validate production processes.
  
• Lead new product launches and process validation (IQ, OQ, PQ).
  
• Serve as SME for machining processes and shop floor inspection methods.
  
• Apply DFM/A principles to optimize manufacturability and product quality.
  
• Evaluate and justify capital equipment purchases (ROI analysis).
  
• Oversee selection and commissioning of new production equipment.
  
• 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.
  
• Act as a key liaison for audits and cross-functional initiatives.
  
• Communicate effectively across all organizational levels.
  

Qualifications

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

Following receipt of a conditional offer of employment, candidates will be required to complete additional job-related screening processes as permitted or required by applicable law .

We are an equal opportunity employer, and all applicants will be considered for employment without attention to their membership in any protected class. If you require any reasonable accommodation to complete your application or any part of the recruiting process, please email your request to [e-mail], and please be sure to include the title and the location of the position for which you are applying.