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About the Role

The Development Engineer I will design and manufacture premium medical devices, transforming concepts into prototypes for testing, validation, and production. This role involves developing systems, processes, and methodologies to enhance product offerings while serving as a technical project leader.

Responsibilities

• Plan, conduct, and manage design and development projects for medical devices.
• Lead the development of new patient-specific products and manufacturing processes.
• Maintain productive dialogue with customers to determine and meet product requirements.
• Determine project schedules by calculating time requirements and sequencing elements.
• Complete technical studies and prepare cost estimates.
• Engage and manage outside contracting services, including laboratories, consultants, and suppliers.
• Research device functionality, patents, and clinical use.
• Design and develop products in compliance with SOP820.030 design control requirements.
• Maintain design files, including testing reports, verification, validation, and design reviews.
• Support company initiatives related to Quality Management Systems and Environmental Management Systems.

Requirements

• Bachelor’s degree in mechanical, materials science, chemical, or biomedical engineering, or equivalent experience.
• 1-3 years of experience in a controlled manufacturing or development environment.
• Experience in an FDA regulated industry or field.
• Exposure to FDA 510(k) process or other regulatory submissions.
• Experience in LEAN manufacturing, GMP, or new product development.

Skills

• Technical project leadership
• Data analysis and documentation
• Process improvement
• Product design and prototyping
• Cross-functional collaboration

Location

• Northeast Portland

Work Type

• Full-time

Experience Level

• 1-3 years

Education Level

• Bachelor’s degree

Benefits

• Medical, Dental, and Vision insurance
• Life and Accidental Death Insurance
• 401(k) with company match and immediate vesting
• Paid Time Off
• 9 company paid holidays
• Referral bonus
• Annual bonus

About the Company

• Riverpoint Medical specializes in the design and manufacturing of premium medical devices for the medical, dental, and veterinary markets.
• Product expertise includes suture technologies, sports medicine fibers and anchors, surgical lighting, and special needle technologies.

Equal Opportunity

• Riverpoint Medical is an equal opportunity employer committed to a diverse and inclusive workplace.
• Does not discriminate based on race, national origin, gender, gender identity, sexual orientation, protected veteran status, disability, age, or other legally protected status.