Manufacturing Engineer II

Riverpoint Medical; Portland (OR); Presencial; USD 80 000 - 110 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Medical, Dental and Vision

Life Insurance

401(k) with company match

Paid Time Off

Company holidays (8)

Retention Bonus

Referral Bonus

Annual Bonus

Resumo da oferta

Riverpoint Medical in Northeast Portland is seeking a Manufacturing Engineer II to develop, maintain, and improve production processes for medical devices across multiple markets. The role partners with Product Development and Quality Assurance to strengthen our quality system and ensure compliant manufacturing practices.

The ideal candidate has a manufacturing engineering background, 3+ years of production support in ISO-regulated environments, and hands-on experience with Lean, automation, and

Qualificações

• Bachelor’s degree in Manufacturing Engineering, Industrial Engineering, Mechanical Engineering or related field.
• Minimum 3 years of direct daily production support in ISO-regulated production.
• FDA-regulated environment experience is desirable; knowledge of cGMP, QSR, ISO 13485.
• LEAN initiatives and Automation experience.
• Proficiency in SolidWorks, MS Word and Excel; ability to write Excel VBA macros and/or Access.
• Strong technical writing skills.
• Able to work in a cleanroom and lift 35 lbs; stand for extended periods.

Responsabilidades

• Coordinate cost/quality improvement projects for in-house production.
• Develop and maintain manufacturing process and assembly documentation procedures.
• Plan and manage equipment purchases and vendor selections for tooling and automation.
• Design jigs and fixtures to support assembly, sterilization, QA, and packaging.
• Support production capacity initiatives and optimize cell layouts.
• Oversee maintenance staff and calibration/records.

Conhecimentos

LEAN initiatives

Automation

SolidWorks

Excel VBA macros

Technical writing

Formação académica

Bachelor's degree in Manufacturing Engineering

Ferramentas

Microsoft Word

Excel

Access

Descrição da oferta de emprego

Riverpoint Medical in Northeast Portland is hiring a Manufacturing Engineer II. 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 II, you will be responsible for developing, maintaining, and improving production, process methods, support documentation systems, tooling, equipment, and production facility maintenance. This position works closely with the Product Development and Quality Assurance / Regulatory Affairs team to strengthen Riverpoint Medical’s quality system and quality culture.

Duties and Responsibilities

• Coordinates and directs the development of cost / quality improvement efforts for in-house production.
• Creates, maintains, and improves manufacturing process and assembly documentation procedures for employee training, maintaining consistent production and quality performance, and meeting quality system requirements.
• Coordinates, directs, and project-manages the design, specification development, cost justification, and vendor selection for equipment purchases, off the shelf, semi-automated, and fully automated.
• Designs jigs and fixtures to support the assembly cells, sterilization, QA, and final product packaging operations.
• 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.
• Provides work assignment direction and oversight for equipment / facility maintenance staff.
• Assists, reviews, and approves calibration and maintenance records.
• 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
• Minimum 3 years of experience providing direct daily production support 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.
• 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 8 company paid holidays. We also reward our team with bonus pay such as Retention Bonus, 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.