Senior Medical Device Product Development Lead

Xeridiem Medical Devices; Tucson (AZ); Presencial; USD 120.000 - 180.000; Jornada completa

Descripción de la vacante

Xeridiem Medical Devices is seeking an experienced Product Development leader to guide a cross-functional team through the full spectrum of medical device development. You will set yearly goals, manage performance, and ensure timely Stage Gate progress toward commercial release while maintaining regulatory and quality standards.

Responsibilities include design reviews, risk management, manufacturability improvements, and collaboration with stakeholders to drive successful product

Formación

• Bachelor’s degree in engineering or related field.
• 10+ years industry experience in medical device development.
• 4+ years in leadership role.
• Strong knowledge of ISO 13485 Design Controls.
• Experience managing Stage Gate through product development.
• Proven ability to manage budgets and revenue recognition.
• Experience design transfer and scale-up for manufacturing.

Responsabilidades

• Provide day-to-day guidance and direction for the Product Development team.
• Set annual goals and objectives and drive accountability.
• Oversee Stage Gate process for commercializing new products.
• Lead design reviews ensuring regulatory and quality requirements are met.
• Ensure design for manufacturability and scalability across production.
• Drive risk management and verification/validation activities.

Conocimientos

Leadership

Project management

Cross-functional collaboration

Regulatory understanding

Risk management

Design controls

Communication

Problem solving

Quality assurance

Educación

Bachelor’s degree in engineering

Master’s degree in engineering (preferred)

Herramientas

Microsoft Project

Descripción del empleo

Xeridiem Medical Devices is seeking an experienced Product Development leader to guide a cross-functional team through the full spectrum of medical device development. You will set yearly goals, manage performance, and ensure timely Stage Gate progress toward commercial release while maintaining regulatory and quality standards.

Responsibilities include design reviews, risk management, manufacturability improvements, and collaboration with stakeholders to drive successful product