Manufacturing Engineer I

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RIVERPOINT MEDICAL LLC

Posted 3 months ago

Full Time

Portland, Oregon

In Person

Smart Summary

Responsibilities

Develop and improve production processes, tooling, and equipment to support the manufacturing of medical devices. Partner with Quality Assurance and Product Development teams to ensure compliance with quality systems and support new product introductions.

Qualifications

You have a Bachelor's degree in a relevant engineering field or equivalent work experience, along with 0-3 years of experience in medical device development and manufacturing. You also possess demonstrated computer skills, including intermediate proficiency in Microsoft Excel and preferably Solidworks, and experience with LEAN initiatives.

Must Have Skills for ATS

ISO13485

cGMP

QSR

LEAN

Solidworks

Excel

Design for Manufacturing (DFM)

Gage R&R

Design of Experiment (DoE)

technical writing

Job Description

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.

Duties and 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. 

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 an FDA regulated environment is highly desirable, along with an understanding of cGMP, QSR, and ISO 13485.
  • Experience with LEAN initiatives.
  • Demonstrated computer skills. Preferably in Solidworks, Microsoft Word, and Excel at an intermediate proficiency level.
  • Experience in Design for Manufacturing (DFM) desirable
  • Experience in Gage R&R creation 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.

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.

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. 

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RIVERPOINT MEDICAL LLC

Riverpoint Medical designs, develops and markets next generation medical devices for the veterinary and healthcare markets. As a flourishing specialty device manufacturer in Portland, we are one of the only suture manufacturers in the US and stand as innovators in synthetic absorbable and orthopedic suture materials. With our HS Fiber® UHMWPE suture line for sports med, we remain the preferred partner for those seeking premium suture solutions for their device. Whether it be a precut non-sterile piece of vibrant blue high strength polyethylene for a shoulder repair suture anchor or a sterile private label dozen box of 24"​ strands with needles, we are there for you. We also manufacture cutting edge LED surgical headlights and have a full line of oncology needle products. We are focused and fast to respond to the market and thrive on innovation to continuously improve the way surgery is done. Contact us today for samples or an estimate: https://rpmed.com/pages/contact
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