Manufacturing Engineer I — Medical Devices, Lean

Riverpoint Medical, LLC; Portland (OR); In loco; USD 60.000 - 80.000; Tempo pieno

Vantaggi offerti da questo lavoro

Medical insurance

Dental insurance

Vision insurance

Life insurance

AD&D insurance

401(k) with company match

Paid time off

8 paid holidays

Retention bonus

Referral bonus

Annual bonus

Descrizione del lavoro

Riverpoint Medical, LLC in Portland, OR is hiring a Manufacturing Engineer I to optimize production lines, tooling, and processes for premium medical devices. You will apply Lean principles, lead continuous improvement initiatives, and perform root-cause analysis to ensure seamless daily production, collaborating with QA, R&D, and regulatory affairs to maintain ISO 13485 compliance.

This entry-level role offers hands-on training in cleanroom operations, cross-functional teamwork, and

Competenze

• Bachelor’s degree in Manufacturing Engineering or related field.
• 0–3 years hands-on production or engineering support in a regulated environment.
• Experience with FDA-regulated environments and understanding of cGMP, QSR, ISO 13485.
• Lean initiatives experience (5S, Kaizen, line balancing).
• Proficiency in 3D CAD modeling (SolidWorks preferred) and MS Office.

Mansioni

• Provide day-to-day engineering support to active manufacturing lines, optimize fixturing and train operators.
• Update process procedures, routings, and assembly documentation to ensure ISO 13485 compliance.
• Collaborate with NPI/R&D during line transfers to review manufacturability and line layouts.
• Lead root-cause investigations (5-Why, Fishbone) to resolve yield drops and downtime.
• Design and validate line-support fixtures and ergonomics across cleanroom cells and packaging.
• Plan throughput expansions, line re-layouts, line balancing, and OEE initiatives.
• Ensure ISO 13485, ISO 14644, and EHS compliance in manufacturing zones.
• Lead NCRs, CAPAs, and supplier defect trend investigations.
• Collaborate with QA and operations for post-launch product enhancements.

Conoscenze

Lean principles

Root cause analysis

ISO 13485

SOP writing

3D CAD

Microsoft Excel

Formazione

Bachelor's degree in Manufacturing/Industrial/Mechanical Engineering

0–3 years in regulated manufacturing

Lean or Six Sigma knowledge

SolidWorks proficiency

Strumenti

SolidWorks

Microsoft Office

Descrizione del lavoro

Riverpoint Medical, LLC in Portland, OR is hiring a Manufacturing Engineer I to optimize production lines, tooling, and processes for premium medical devices. You will apply Lean principles, lead continuous improvement initiatives, and perform root-cause analysis to ensure seamless daily production, collaborating with QA, R&D, and regulatory affairs to maintain ISO 13485 compliance.

This entry-level role offers hands-on training in cleanroom operations, cross-functional teamwork, and