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BioTalent

BioTalent

via LinkedIn

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Senior Development Engineer

Portland, OR
full-time
Posted 9/17/2025
Verified Source
Key Skills:
Medical device design
CAD (SolidWorks)
Regulatory compliance (FDA 510(k))
Project management
Prototyping and testing
LEAN and GMP

Compensation

Salary Range

$80K - 120K a year

Responsibilities

Lead medical device design and development projects from concept through production, including prototyping, testing, validation, and regulatory compliance.

Requirements

Bachelor's degree in engineering, 4-10 years medical device development experience, proficiency in CAD, and knowledge of regulatory standards.

Full Description

Development Engineer III – Medical Devices 📍 Northeast Portland, OR | On-site We’re seeking a Development Engineer III to drive the design, development, and improvement of innovative medical devices. In this role, you’ll transform concepts into prototypes, lead technical projects, and guide products through testing, validation, and into production. Key Responsibilities • Lead design and development projects for medical devices, from concept through production • Collaborate with customers to define requirements and ensure needs are met • Create prototypes, perform testing, and oversee verification/validation activities • Manage project schedules, risks, costs, and compliance with regulatory standards • Mentor junior engineers and coordinate with external partners and suppliers • Prepare technical reports, cost estimates, and design documentation Qualifications • Bachelor’s degree in Mechanical, Biomedical, Electrical, Materials, or Chemical Engineering (or equivalent) • 4–10 years of experience in medical device development, reprocessing, or manufacturing • Proficiency in CAD (SolidWorks preferred) • Experience with FDA 510(k) or other regulatory submissions is a plus • Background in LEAN, GMP, or new product development preferred • Strong problem-solving, documentation, and communication skills

This job posting was last updated on 9/23/2025

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