Process Engineer III

Riverpoint Medical; Portland (OR); On-site; USD 85,000 - 120,000; Full time

Job summary

A leading company in medical equipment manufacturing is seeking a Process Engineer III to drive improvements in internal systems and processes. This role involves collaboration with various teams to ensure compliance and manage projects effectively. Ideal candidates will have a relevant engineering degree and substantial experience in the medical device industry, particularly in FDA-regulated environments.

Benefits

Medical Insurance

Dental Insurance

Vision Insurance

Life Insurance

401(k) with match

Paid Time Off

Holidays

Qualifications

• 4-10 years of experience in medical device product development or manufacturing.
• Experience with FDA-regulated environments and regulatory submissions.
• Experience in equipment and process validation (IQ/OQ/PQ).

Responsibilities

• Plan, manage, and execute projects supporting strategic goals.
• Coordinate activities with internal and external teams.
• Ensure compliance with quality control and assurance standards.

Skills

Project Management

Compliance

Quality Control

LEAN Manufacturing

GMP

Education

Bachelor’s degree in Mechanical, Materials Science, Chemical, Electrical, or Biomedical engineering

Graduate degree preferred

Job description

Job Title and Company

Join to apply for the Process Engineer III role at Riverpoint Medical.

Overview

Riverpoint Medical in Portland, Oregon is seeking a Process Engineer III. The role involves driving proactive improvements to internal systems, processes, and new equipment validations. The PE will collaborate with Operations, New Product Development, Quality, and Regulatory teams to develop robust process improvements.

Responsibilities

1. Plan, manage, and execute projects supporting the company's strategic goals through ECO processes.
2. Organize project elements and coordinate activities with internal and external teams.
3. Implement customer requirements into the Riverpoint QMS system.
4. Determine project schedules based on plans and specifications.
5. Assist in managing compliance, quality control, and assurance standards.
6. Engage with external contractors and suppliers to support project needs.
7. Build effective relationships to meet delivery and budget goals.
8. Ensure completion of new product documentation, labeling, and ERP functions for production transfer.
9. Support initiatives related to QMS, EMS, and other regulatory requirements.

Qualifications

• Bachelor’s degree or equivalent in Mechanical, Materials Science, Chemical, Electrical, or Biomedical engineering; graduate degree preferred.
• 4-10 years of experience in medical device product development, manufacturing, or reprocessing.
• Experience with FDA-regulated environments and regulatory submissions such as FDA 510(k).
• Experience in equipment and process validation (IQ/OQ/PQ).
• Experience in LEAN Manufacturing, GMP, or New Product Development.
• Experience with sterilization, sealing, or packaging in medical devices is a plus.

Benefits

Medical, Dental, Vision, Life Insurance, 401(k) with match, Paid Time Off, and holidays.

Additional Information

Riverpoint Medical is an equal opportunity employer committed to diversity and inclusion.

Job Details

• Seniority level: Mid-Senior level
• Employment type: Full-time
• Job functions: Management and Manufacturing
• Industry: Medical Equipment Manufacturing