Development Engineer

Development Engineer I 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 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. Candidate Profile Thrives in an environment where technical learning is hands on. Desire to be creative, improve processes and find solutions for the next generation of medical devices. Detail 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. Excited at the opportunity to be a technical project leader interacting with our customers. Responsibilities Plan, conduct, and manage design and development projects for medical devices in support of the company's strategic plan. Lead 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. Determine project schedule by studying project plan and specifications, calculating time requirements, and sequencing project elements. Complete technical studies and prepare 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. 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. Preferred Qualifications 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. Benefits Medical, Dental and Vision, Life and Accidental Death Insurance; 401(k) with company match and immediate vesting, Paid Time Off and 9 company paid holidays. Bonus pay such as Referral Bonus and Annual Bonus available. 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. #J-18808-Ljbffr Riverpoint Medical