10 дней назад
Associate Systems Engineer, V&V Tijuana (Hybrid)
Мэтч & Сопровод
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Описание вакансии
Текст:
TL;DR
Associate Systems Engineer, V&V Tijuana (Hybrid) (Medical Devices): Supporting the development and verification of wearable medical devices across the product development lifecycle with an accent on requirements documentation, device integration, laboratory testing, and design controls. Focus on executing design verification tests, troubleshooting design issues, preparing feasibility protocols and reports, and supporting regulatory clearance and commercial release.
Location: Aviacon, Tijuana, Mexico; hybrid
Company
develops the Omnipod wearable pump platform and other innovative, waterproof medical technologies designed to improve patient lives.
What you will do
- Support the development of wearable medical devices throughout the design and development lifecycle.
- Collaborate with Systems Engineers and R&D teams to troubleshoot design issues and identify improvements.
- Write and interpret product requirements, engineering change orders, build requests, feasibility protocols, and reports.
- Design and conduct feasibility tests in a laboratory environment while managing engineering materials.
- Execute design verification testing for design improvements, regulatory clearance, and commercial release.
- Participate in product and technical reviews, triage sessions, device integration, and design documentation.
Requirements
- Bachelor’s degree in Biomedical Engineering, Electrical Engineering, Computer Science, or a related engineering discipline.
- Technical writing, effective communication, planning, and prioritization skills.
- Hands-on experience with laboratory testing equipment and Microsoft Office.
- Knowledge of engineering principles, scientific methods, and medical device development or regulations.
- Ability to work in a fast-paced, dynamic environment and sit or stand for up to 8 hours per day.
- Typically 1–2 years of experience as a Systems or Project Engineer in medical devices, a regulated industry, or equivalent experience.
Nice to have
- Understanding of communication technologies, mobile technology, and IoT.
- Experience with Jira, Helix, Bamboo, Bitbucket, MATLAB, SolidWorks, or Pro/Engineer.
- Hands-on, inquisitive approach and willingness to challenge design decisions.
Culture & Benefits
- Cross-functional collaboration with R&D teams throughout the product development lifecycle.
- Broad exposure to wearable pump technology, systems engineering, and regulated medical device development.
- Environment focused on continuous learning, innovation, and improving patient outcomes.
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