Process Engineer III

ZipRecruiter; Portland (OR); On-site; USD 80,000 - 110,000; Full time

Job summary

Riverpoint Medical in Portland, Oregon is seeking a Process Engineer III to enhance internal systems and lead projects related to medical devices. This role entails collaboration with various teams for process improvement and compliance with quality standards, making it crucial for the company's innovative technology to thrive. A Bachelor’s in Engineering and relevant experience in the medical field are necessary for this position.

Benefits

Medical, Dental and Vision Insurance

401(k) with company match and immediate vesting

Paid Time Off

9 company paid holidays

Qualifications

• 4-10 years of medical device experience in product development or manufacturing.
• Experience with FDA regulations and equipment/process validation.
• Background in LEAN Manufacturing and GMP practices.

Responsibilities

• Plan, conduct, and manage projects per the strategic plan.
• Ensure compliance with quality control standards.
• Implement customer requirements into internal systems.

Skills

Project Management

Regulatory Compliance

Process Improvement

Technical Communication

Education

Bachelor’s degree in Engineering

Job description

Job DescriptionJob Description

Riverpoint Medical in Portland, Oregon is looking to hire a Process Engineer III. 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. Riverpoint Process Engineer III is responsible for 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 produce robust solutions towards process improvement.

Duties & Responsibilities:

• Plan, conduct, and manage projects in support of the company's strategic plan through implementation of the ECO processes.
• Complete engineering projects by organizing and controlling project elements and coordinating activities (internal and external) of the project team.
• Understand customer requirements and effectively implement them into the Riverpoint QMS system.
• Determines project schedule by studying project plan and specifications, calculating time requirements, and sequencing project elements.
• Assist in the management of compliance, quality control, and quality assurance standards and specifications.
• Engage outside contracting services in support of project needs, i.e. analytical laboratories, consultants, material suppliers and equipment suppliers.
• Build effective relationships with these resources to meet delivery and budgetary goals.
• Ensure completion of new product additions across all build documentation, labeling, and ERP functions for effective transfer to production.
• Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.

Education and Qualifications:

• Bachelor’s degree or equivalent work experience in Mechanical, Materials Science, Chemical, Electrical or Biomedical engineering, graduate degree .
• Previous experience working with medical devices, product development, reprocessing and/or manufacturing (4-10 years).
• Regulatory Experience working in an FDA regulated environment, or similar (4-10 years).
• Experience executing equipment and process validation activities such as IQ/OQ/PQ
• Exposure to the FDA 510(k) process or other regulatory submissions
• Prior experience in a LEAN Manufacturing/Production environment, GMP and/or New Product Development
• Prior experience in medical device sterilization, sealing and/or packaging .

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.

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 , , , , , protected veteran status, , , or other legally protected status.