Develop Engineer II

RIVERPOINT MEDICAL LLC•Portland, OR

About The Position

Riverpoint Medical is hiring a Development Engineer II in Northeast Portland. The company designs and manufactures premium medical devices for medical, dental, and veterinary markets, including suture technologies, sports medicine fibers and anchors, surgical lighting, and special needle technologies. The Development Engineer II develops systems, processes, methodologies, and products to enhance the company’s offerings, transforming concepts into prototypes for testing, validation, and production improvement.

Requirements

Bachelor’s degree in Mechanical, Materials Science, Chemical, Electrical, or Biomedical Engineering.
3–5 years of experience in a controlled manufacturing or development environment.
2–5 years of experience in an FDA-regulated industry or field, or similar.

Nice To Haves

Experience in an FDA-regulated industry or field, or similar.
Exposure to the FDA 510(k) process or other regulatory submissions.
Experience in a LEAN manufacturing or production environment, GMP, and/or new product development.

Responsibilities

Plan, conduct, and manage medical-device design and development projects in support of the company’s strategic plan.
Lead development of new patient-specific products and associated manufacturing processes.
Maintain productive, respectful dialogue with customers to determine product requirements and meet customer needs.
Develop project schedules by reviewing plans and specifications, calculating time requirements, and sequencing project elements.
Complete technical studies and prepare cost estimates.
Manage compliance, quality-control, and quality-assurance standards and specifications.
Mentor, lead, and coach other engineering staff.
Engage outside contractors and suppliers—including analytical laboratories, consultants, material suppliers, and equipment suppliers—and build relationships that support delivery and budget goals.
Research and understand device functionality, patents, and clinical use.
Design and develop products in compliance with Riverpoint Medical Design Control requirements per SOP820.030; maintain product design files, including testing and reports, verification, validation, and design reviews.
Support company initiatives and requirements related to Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory obligations.