Manufacturing Engineer I

Riverpoint Medical, LLC; Portland (OR); On-site; USD 60,000 - 80,000; Full time

Benefits offered by this job

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

Job summary

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

Qualifications

• 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.

Responsibilities

• 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.

Skills

Lean principles

Root cause analysis

ISO 13485

SOP writing

3D CAD

Microsoft Excel

Education

Bachelor's degree in Manufacturing/Industrial/Mechanical Engineering

0–3 years in regulated manufacturing

Lean or Six Sigma knowledge

SolidWorks proficiency

Tools

SolidWorks

Microsoft Office

Job description

Riverpoint Medical in Northeast Portland is hiring a Manufacturing Engineer I. At Riverpoint you will be part of the process that brings great technology to Medical, Dental and Veterinary markets. We specialize in the design and manufacturing of premium medical devices. Our ingenuity can be found in our suture technologies, sports medicine fibers and anchors, surgical lighting, and special needle technologies. As a Manufacturing Engineer I, you will play a central role in optimizing the production, tooling, equipment, and processes that power our medical device manufacturing. Working closely with Operations, Quality Assurance, and Regulatory Affairs, you will apply Lean principles, lead continuous improvement initiatives, and perform root-cause analysis to ensure seamless daily production. Join Riverpoint Medical and help us deliver top-tier suture technology to clinicians worldwide!

Duties and Responsibilities

• Provides dedicated day-to-day engineering support to active manufacturing lines, optimizing fixturing, updating work instructions, and delivering hands-on training to production operators to improve yield and efficiency.
• Maintains and updates manufacturing process procedures, routings, and assembly documentation via change orders to ensure consistent line performance, operator training, and continuous ISO 13485 compliance.
• Partners with NPI and R&D teams during line transfer to review manufacturability, establish robust downstream line layouts, and ensure seamless handoffs into commercial manufacturing.
• Leads structured root cause investigations (e.g., 5-Why, Fishbone) to diagnose and resolve real-time yield dropoffs, equipment downtime, and technical line disruptions on active production lines.
• Designs, modifies, and validates line-support jigs, assembly fixtures, and ergonomics enhancements across cleanroom assembly cells, sterilization preparation, QA inspection, and final packaging.
• Plans and executes throughput expansion projects, cell re-layouts, line balancing, and overall equipment effectiveness (OEE) initiatives to meet growing commercial sales demands.
• Partner with QA and Facilities to ensure active manufacturing zones continuously comply with ISO 13485 quality standards, ISO 14644 cleanroom requirements, EHS guidelines, and Riverpoint Medical SOPs.
• Leads technical investigations for product/process Nonconformance Reports (NCRs), customer complaints, supplier defect trends, and Corrective and Preventive Actions (CAPA) to drive long-term corrective measures.
• Collaborates with Operations, Quality, and commercial key account teams to execute post-launch product enhancements, value engineering initiatives, and customer-driven line updates.

Education and Qualifications

• Bachelor’s degree in Manufacturing Engineering, Industrial Engineering, Mechanical Engineering or other related field of study or equivalent work experience.
• 0–3 years of hands‑on production or engineering support experience in a regulated manufacturing environment (internship, co‑op, or project experience in medical device manufacturing inclusive)
• Production support experience supporting a FDA regulated environment is highly desirable, along with an understanding of cGMP, QSR, and ISO 13485.
• Knowledge or practical exposure to Lean initiatives (e.g., 5S, waste reduction, line balancing, Kaizen events).
• Proficiency in 3D CAD modeling (SolidWorks preferred) and Microsoft Office Suite (Excel, Word).
• Exposure to Design for Manufacturability (DFM) concepts and basic fixture/tooling design principles.
• Strong technical writing skills for creating and updating Work Instructions, SOPs, and engineering change notices.
• Able to work in an ISO‑classified cleanroom environment, including adherence to standard cleanroom gowning procedures. Capability to stand and move around the manufacturing floor for extended periods and occasionally lift/move up to 35 lbs.

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 8 company paid holidays. We also reward our team with bonus pay such as Retention Bonus, Referral Bonus and Annual Bonus!

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.