обновлено 19 часов назад
Sr. Product Development Engineer-Shoulders (Medical Devices)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Sr. Product Development Engineer-Shoulders (Medical Devices): Developing surgical instruments and implants for total shoulder arthroplasty with an accent on 3D CAD design, design documentation, verification and validation, and FDA/ISO compliance. Focus on translating surgeon requirements into technically sound products, defining testing requirements, and coordinating cross-functional development from proposal through final design release.
Location: Austin, Texas, United States; on-site work across office, manufacturing, mechanical testing, and cadaver lab environments
Company
is a medical technology company developing orthopedic products, services, and integrated technologies to improve patient outcomes and restore movement.
What you will do
- Contribute to new product development projects from proposal through final design and release.
- Translate surgeon requirements and product characteristics into designs for total shoulder arthroplasty instruments and implants.
- Develop concepts and mechanisms using 3D modeling in SolidWorks and review designs for feasibility, accuracy, and technical soundness.
- Create and maintain risk assessments, design reviews, engineering drawings, test plans, design verification and validation records, and Design History Files.
- Define testing requirements and support compliance with FDA, ISO, and internal procedures.
- Collaborate with manufacturing, supply chain, quality assurance, regulatory, marketing, and other engineering functions while maintaining project schedules and budgets.
Requirements
- At least 8 years of design and development experience.
- Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, or an equivalent discipline.
- Experience with 3D CAD packages; SolidWorks is preferred.
- Knowledge of word processing, spreadsheet, internet, contact management, and change management software.
- Must already have full-time work authorization in the United States and be able to maintain it without current or future visa sponsorship.
- Ability to analyze data, define problems, prepare detailed test protocols and reports, and communicate with managers, customers, surgeons, and regulatory stakeholders.
Nice to have
- Experience in medical devices, orthopedics, or another regulated industry.
- Engineering co-op or internship experience.
- Experience presenting technical information and responding to customer, regulatory, or design surgeon inquiries.
Culture & Benefits
- Collaborative, cross-functional product development environment focused on scientific excellence and continuous improvement.
- Participation in surgeon symposia, focus groups, consultant meetings, and cadaver labs.
- Medical, dental, and vision insurance.
- Spending and savings accounts, 401(k), vacation, sick leave, holidays, income protection plans, discounted insurance rates, and legal services.
- Approximately 10% travel is required.
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