6 дней назад
Director, Product Development (Navigation and Computer Vision)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Director, Product Development (Navigation and Computer Vision): Leading the surgical navigation and computer vision product development program for medical devices with an accent on multidisciplinary engineering leadership, rapid product introductions, design controls, and regulatory compliance. Focus on building the technology roadmap, managing sustaining and quality activities, and coordinating FDA 510(k), IDE, and PMA submissions.
Location: Methuen, Massachusetts, United States
Company
develops medical technologies and surgical solutions for patients with musculoskeletal disorders.
What you will do
- Lead the surgical navigation and computer vision product development program.
- Manage and develop a multidisciplinary team spanning electrical, mechanical, software, algorithms, systems engineering, and product management.
- Drive rapid new product introductions, sustaining efforts, complaint resolution, and corrective actions.
- Own the product portfolio, development process, design controls, and device design history files.
- Build the navigation and computer vision technology strategy and roadmap, supported by market analysis and product planning.
- Coordinate quality, clinical, regulatory, marketing, and strategic business initiatives, including FDA submissions.
Requirements
- Bachelor’s degree with 10+ years of related business experience, or a master’s degree with 7+ years of experience.
- Experience with new product introduction, design control processes, and lifecycle management.
- Strong project management, communication, problem-solving, organizational, technical, and business skills.
- Experience in a highly technical and regulated industry, preferably involving medical devices, navigation, or computer vision.
- Familiarity with FDA 21 CFR, the 510(k) process, and standards including IEC 60601, IEC 62304, and IEC 62366.
- Proficiency with Microsoft Office Suite and Microsoft Project; availability to travel 10–20% of the time.
Culture & Benefits
- Values emphasize innovation, customer focus, teamwork, and decisive results.
- Work includes collaboration with surgeons, researchers, educators, regulatory bodies, clinical investigators, and cross-functional teams.
- Physical requirements include sitting, climbing or balancing, stooping, kneeling, crouching or crawling, and lifting up to 25 pounds occasionally.
- Reasonable accommodations may be provided for individuals with disabilities.
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