Development Engineer

RIVERPOINT MEDICAL LLC•Portland, OR

8h•Onsite

About The Position

Riverpoint Medical in Northeast Portland is hiring a Development 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. The Riverpoint Development Engineer I will develop systems, processes, methodologies as well as product development to enhance our product offering. Transforming concepts into prototypes for testing, validation, and improvement for production. We Are Seeking an Individual who: Thrives in an environment where technical learning is hands on. A desire to be creative, improve processes and find solutions for the next generation of medical devices. Is detailed oriented to plan, execute, and document their work through reports and data analysis. Enjoys a team model where all individuals are encouraged for personal growth. Is excited at the opportunity to be a technical project leader interacting with our customers.

Requirements

Bachelor’s degree in mechanical, materials science, chemical, or biomedical engineering or similar or equivalent work experience
1-3 years’ experience working in a controlled manufacturing or development environment.

Nice To Haves

Experience working in an FDA regulated industry/field, or similar.
Exposure to the FDA 510(k) process or other regulatory submissions.
Experience in a LEAN Manufacturing/Production environment, GMP and/or New Product Development.

Responsibilities

Plan, conduct, and manage design and development projects for medical devices in support of the company's strategic plan.
Leads to the development of new patient specific products and associated manufacturing processes.
Maintain productive and respectful dialogue with customers to determine product requirements and ensure customer needs are met.
Determines project schedule by studying project plan and specifications, calculating time requirements, and sequencing project elements.
Completes technical studies and prepares cost estimates.
Engage outside contracting services in support of project needs, i.e., analytical laboratories, consultants, material suppliers and equipment suppliers. Build effective relationships with these resources to meet delivery and budgetary goals.
Research and understand device functionality, device patents, and clinical use.
Design and develop products in full compliance with the Riverpoint Medical Design Control requirements per SOP820.030, and maintain design files for company products, including testing, testing reports, verification, validation, design files, and design reviews.
Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.