Senior Manager, Instruments

Intuitive•Sunnyvale, CA

About The Position

The Senior Manager of Instruments guides the design, development, documentation, and verification of new and derivative complex flexible instruments. They will lead multiple design teams and are responsible for design, development, project schedules, product performance against requirements and the management of a multi-disciplinary group of engineers and other technical personnel to ensure efficient product development.

Requirements

Minimum 10 years of experience designing and developing medical instruments, especially in the flexible and/or endoluminal space
Minimum 5 years as a people manager, or equivalent project/team leadership, with proven ability to work well in a team environment while managing multiple projects and/or teams
Hands-on engineering manager with the proven ability to work with highly technical teams
Strong understanding and experience of design control, risk management and design V&V from early design and development through commercialization as described in ISO 13485, ISO 14971 and FDA Quality System Regulations
Knowledge of and experience with CAD and analysis tools that drive design excellence
Expertise in biocompatibility principles and regulatory requirements, e.g. ISO 10993
Knowledge of reprocessing and high-level disinfection requirements for reusable medical devices and applicable standards, e.g., ISO 17664
Experience with root cause analysis and design of experiments
Strong project management, planning, and change management skills
Ability to lead/influence cross functional teams in the design of complex medical systems
Experience designing products in a highly regulated environment
Excellent communication (written, verbal), presentation and documentation skills
Strong people management abilities with capability to ensure team success (staffing, productivity) as well as career development of team members

Responsibilities

Provide vision for technical project team and foster environment that encourages creativity, risk taking, and crisp execution
Develop working knowledge of external customer needs/requirements to ensure product designs provide value to patients, physicians and hospitals
Establish group objectives and individual work goals consistent with overall product development goals
Assign tasks, set priorities, establish metrics, and track progress
Assess employee performance and provide coaching to improve performance
Manage, coach, and mentor engineers, technicians, and drafters as required
Ensure design engineers follow appropriate design history file guidelines per FDA requirements and hold design reviews in accordance with product development procedures
Provide engineering resources to support Process Development, Manufacturing, Supplier Engineering, Test Engineering, and Quality to facilitate transfer of designs
Provide administrative leadership / control for planning, staffing, budgeting, and project/program cost tracking
Build and maintain strong partnerships with cross-functional stakeholders including Product Management, Clinical Research, Clinical and Medical Affairs, Process Development, Testing, Supplier, Quality, Regulatory Affairs and Marketing to ensure alignment throughout product development and lifecycle management
Serve as the primary R&D liaison to senior leadership and in cross-functional meetings, presenting technical updates, design rationale, and risk mitigation strategies