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.
Location: Hillsboro, Oregon
Job Scope
The Manufacturing Engineer develops, validates, and improves manufacturing processes and systems to support production and New Product Introduction (NPI). This role drives continuous improvement, reduces waste, and supports Cost of Goods Sold (COGS), On-Time Delivery (OTD), and product quality objectives while ensuring compliance with FDA regulations, ISO 13485, and Good Manufacturing Practices (GMPs).
Duties/Responsibilities
- Develop, implement, validate, and improve manufacturing processes, equipment, and systems to enhance efficiency, quality, and reliability.
- Provide hands-on engineering support, troubleshoot production issues, perform root cause analysis, and implement corrective actions.
- Drive continuous improvement initiatives to reduce waste, improve cycle times, increase yields, and lower manufacturing costs.
- Support NPI activities, including process development, equipment and tooling selection, validation, and production readiness.
- Develop and maintain work instructions, SOPs, process specifications, and validation documentation.
- Perform process validations, including IQ, OQ, and PQ, to ensure manufacturing requirements are met.
- Apply statistical analysis, process capability studies, FMEA, and other problem-solving tools to improve processes and mitigate risks.
- Collaborate with Quality, R&D, Operations, and Supply Chain to resolve manufacturing challenges and support engineering changes.
- Utilize CAD software to support tooling, fixtures, equipment, and process improvements.
- Ensure compliance with FDA regulations, ISO 13485, GMPs, and internal quality standards.
Qualifications
- Bachelor's degree in Mechanical, Manufacturing, Industrial Engineering, or equivalent.
- 2+ years of manufacturing engineering or related experience.
- Basic 3D CAD proficiency (Creo, SolidWorks, or equivalent).
- Strong analytical, root cause analysis, problem-solving, and communication skills.
- Ability to collaborate effectively across departments.
- Understanding of process validation (IQ/OQ/PQ), statistical tools (DOE, control charts, capability studies), and Minitab or equivalent.
- Knowledge of FDA regulations, ISO 13485, risk management, and FMEA.
- Familiarity with cleaning, passivation, labeling, packaging, and laser marking.
- Understanding of ISO Class 7/8 cleanroom monitoring and maintenance.
- Packaging automation or medical device packaging experience a plus.
- Regulated manufacturing experience desired; medical device experience preferred.
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 [email protected], and please be sure to include the title and the location of the position for which you are applying.
