Manufacturing Engineer

Riverpoint Medical in Portland, Oregon is seeking a Manufacturing Engineer III to support the development and production of premium medical devices. In this role, you will help advance the equipment and processes behind our innovative technologies serving the Medical, Dental, and Veterinary markets—including suture systems, sports‑medicine fibers and anchors, surgical lighting, and specialized needle technologies. The ME III serves as the technical lead for equipment performance, equipment selection, process optimization, and new equipment validation, with a primary focus on Braiding Operations and related material processes. You will collaborate closely with Operations, New Product Development, Quality, and Regulatory teams to deliver robust, scalable process and equipment improvements. Duties & Responsibilities: Lead equipment‑driven process improvements within Braiding Operations , including capability upgrades, equipment configuration, and optimization of material‑handling systems. Own the lifecycle of production equipment—specification, procurement, installation, startup, qualification, and performance monitoring. Develop and execute equipment validation protocols (IQ/OQ/PQ) to ensure compliance with medical‑device regulatory requirements. Partner with Maintenance and Operations in support of preventive and predictive maintenance programs for Barding Operations equipment. Plan and execute engineering projects, DOEs, and engineering studies through structured project control and effective coordination of cross‑functional internal teams and external technical partners. Analyze equipment and process data to identify variation sources and implement engineering controls or equipment upgrades that improve yield and reduce scrap. Collaborate with New Product Development to translate product requirements into equipment needs and scale new technologies into production. Generate and maintain engineering documentation including equipment specifications, PFMEAs, process flow diagrams, work instructions, and validation records. Support regulatory, customer, and internal audits related to equipment, process controls, and validation activities. Support all company initiatives related to Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements ensuring equipment and processes meet quality and environmental standards. Education and Qualifications: Bachelor’s degree in Mechanical, Materials Science, Chemical, Electrical, or Biomedical Engineering, or equivalent experience; advanced degree preferred. 4–10 years of experience in medical device manufacturing, product development, equipment sustaining or related production environments. Experience implementing continuous‑monitoring systems (non‑connected) and establishing Statistical Process Control (SPC) methodologies. 4–10 years of experience working in an FDA‑regulated/GMP-regulated environment or similar regulated industry. Proven experience executing equipment and process validation activities, including IQ, OQ, and PQ. Exposure to FDA 510(k) submissions or other regulatory submission processes. We offer great benefits: Medical, Dental and Vision, Life and Accidental Death Insurance; 401(k) with company match and immediate vesting, Paid Time Off and 9 company paid holidays. Riverpoint Medical is committed to a diverse and inclusive workplace. Riverpoint Medical is an equal opportunity employer and does not discriminate on the basis of race, national origin, gender, gender identity, sexual orientation, protected veteran status, disability, age, or other legally protected status. #J-18808-Ljbffr