Manufacturing Engineer I
RIVERPOINT MEDICAL LLC
Summary
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!
Job description
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.
Requirements
- 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.
Benefits
- Medical, Dental & Vision
- Life Insurance
- Accidental Death Insurance
- 401(k) Matching
- Paid Time Off
- Paid Holidays
- Retention Bonus
- Referral Bonus
- Annual Bonus
Company overview
Riverpoint Medical is a leading medical device manufacturer specializing in the design, development, and production of next-generation surgical solutions. Founded in 2008 and headquartered in Portland, Oregon, the company has grown from a small family-run business into a crucial player in the medical device manufacturing market. Riverpoint Medical stands out as one of the few remaining suture manufacturers in the United States, with particular expertise in synthetic absorbable and orthopedic suture materials. The company's product portfolio includes high-performance surgical sutures for both human and veterinary markets, orthopedic and sports medicine implants, high-strength fiber solutions, cordless LED surgical headlights, and brachytherapy products for oncology applications. With their proprietary HS Fiber® UHMWPE suture line for sports medicine, Riverpoint has established itself as a preferred partner for premium suture solutions. The company operates comprehensive facilities that support start-to-finish capabilities, including product design, engineering, R&D, material expertise, quality control, and regulatory compliance, enabling clients to bring innovative medical devices to market more efficiently.