Manufacturing Engineer Job at Riverpoint Medical in Oregon

Overview

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, supporting documentation systems, tooling, and equipment. If your passion is to provide hands-on production floor support during product development as well as perform critical thinking analytical work, apply today.

Duties and Responsibilities

• Supports major manufacturing functions in front-end process (braiding, washing, cutting and heat tipping) as they pertain to equipment IQ/OQ execution.
• Creates, maintains, and improves manufacturing process and assembly documentation (work instructions, BOMs, drawings) as well as procedure improvements for employee training, maintaining consistent production and quality performance, and meeting quality system requirements.
• Acts as a key member in support of OPEX projects, driving documentation and equipment validation.
• Collaborates with senior engineers on cross-functional teams such as supply chain, regulatory and quality to aid in closing of critical tasks as they pertain to products already validated and released to manufacturing.
• Collaborates on design and development of process fixtures as necessary for the complete manufacturing process.
• Leads root cause analysis sessions to drive and determine root cause to problems occurring in the new product development process.
• Plans, coordinates, and directs the development of new production capacity initiatives to support the company’s business / sales plan. Includes planning and maximizing production area and cell layouts.
• 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.

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 experience providing medical device development and manufacturing in a high-mix, high and low volume, ISO regulated production environment.
• Production support experience supporting a FDA regulated environment is highly desirable, along with an understanding of cGMP, QSR, and ISO 13485.
• Experience with LEAN initiatives and Automation
• Demonstrated computer skills. Preferably in Solidworks, Microsoft Word and Excel at an intermediate to advanced proficiency level. Ability to write Excel VBA macros and / or Microsoft Access or other database software programming skills are desirable.
• Experience in Design for Manufacturing (DFM) desirable
• Experience in Design of Experiment (DoE) creation desirable
• Demonstrated technical writing skills.
• Must be able to work in a cleanroom and gown up, lift 35 lbs, and stand on feet for extended periods of time.

Benefits

We offer great 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. We also reward our team with bonus pay such as, Referral Bonus and Annual Bonus!

Equal Employment Opportunity

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.

Job details

• Seniority level: Associate
• Employment type: Full-time
• Job function: Manufacturing and Engineering
• Industries: Medical Equipment Manufacturing