Manufacturing Engineer I

Riverpoint Medical Llc; Portland (OR); On-site; USD 55,000 - 75,000; Full time

Benefits offered by this job

Retention Bonus

Annual Bonus

401(k) with company match

Paid Time Off

Job summary

Riverpoint Medical in Northeast Portland is seeking a Manufacturing Engineer I to optimize production lines, tooling, equipment, and processes for medical device manufacturing. You will work with Operations, QA, and Regulatory Affairs to apply Lean principles, lead continuous improvement, and perform root-cause analysis to minimize downtime and improve yield.

The role focuses on line support, jigs, fixtures, line balancing, and ensuring ISO 13485 and cleanroom standards.

Qualifications

• Bachelor's degree in Manufacturing Engineering, Industrial Engineering, Mechanical Engineering or related field or equivalent work experience.
• 0–3 years of hands-on production or engineering support in a regulated manufacturing environment.
• Experience with FDA-regulated environments, cGMP, QSR, ISO 13485 is desirable.
• Knowledge of Lean concepts (5S, waste reduction, line balancing, Kaizen).
• Proficiency in 3D CAD modeling and MS Office; exposure to DFManuf concepts and basic fixture/tooling design.

Responsibilities

• Provide day-to-day engineering support to active manufacturing lines; optimize fixturing and update work instructions.
• Update process procedures and routings to ensure ISO 13485 compliance.
• Collaborate with NPI/R&D for line transfers and manufacturability reviews.
• Lead root-cause investigations (5-Why, Fishbone) to resolve yield/downtime issues.
• Design and validate line-support fixtures, ergonomics improvements, and tooling.

Skills

Lean principles

Root-cause analysis

Technical writing

Team collaboration

Education

Bachelor's degree in Manufacturing/Industrial/Mechanical Engineering or related field

Tools

SolidWorks

Microsoft Excel

Microsoft Word

Job description

If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process.

Manufacturing Engineer I

Full Time Portland, OR, US

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.