Manufacturing Engineer I

RIVERPOINT MEDICAL LLC•Portland, OR

1d•Onsite

About The Position

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 full-time Manufacturing Engineer I, you will be responsible for developing, maintaining, and improving production, process methods, support documentation systems, tooling, and equipment. This position will work in the Product Development group and partner with Quality Assurance / Regulatory Affairs team to strengthen Riverpoint Medical’s quality system and quality culture. If your passion is to provide hands-on production floor support during product development as well as perform critical thinking analytical work, apply today.

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 experience providing medical device development and manufacturing in a high-mix, high and low volume, ISO regulated production environment.
Demonstrated computer skills. Preferably in Solidworks, Microsoft Word, and Excel at an intermediate proficiency level.
Demonstrated technical writing skills.

Nice To Haves

Production support experience supporting an FDA regulated environment is highly desirable, along with an understanding of cGMP, QSR, and ISO 13485.
Experience with LEAN initiatives.
Experience in Design for Manufacturing (DFM) desirable
Experience in Gage R&R creation desirable
Experience in Design of Experiment (DoE) creation desirable

Responsibilities

Supports the manufacturing function of the new product development process including fixturing design, work instruction development, and production training and support.
Creates, maintains, and improves manufacturing process and assembly documentation procedures for employee training, maintaining consistent production and quality performance, and meeting quality system requirements.
Acts as key member on New Product Introduction teams by partnering with Development Engineers in providing feedback on product manufacturability.
Supports root cause analysis sessions to drive and determine root cause to problems occurring in the new product development process.
Designs jigs and fixtures to support the assembly cells, sterilization, QA, and final product packaging operations.
Coordinates and supports QA in implementing relevant area compliance with regards to quality (ISO13485), safety, environmental (ISO 14644), and Riverpoint Medical standard procedures.
Assists in process investigations of complaints, root cause assessments, nonconformity (NCR), and corrective and preventive action (CAPA) activities.
Collaborates with Riverpoint’s key customers in product development process.