Director, Instruments and Accessories

Intuitive•Sunnyvale, CA

About The Position

The Director of Instruments and Accessories leads the strategy, design, development, documentation, and verification of new and derivative complex flexible medical instruments and system accessories. They will lead multiple managers and are responsible for helping lead the identification and creation of product requirements and driving the design, development, project schedules, and product performance against those requirements as well as the management of multiple groups of managers and engineers to ensure efficient product development that meets market, patient, user, and business needs. The successful candidate will coordinate team efforts across multiple projects, manage personnel efficiently, and ensure project milestones are met despite time constraints and evolving information typical of new product development.

Requirements

12 years experience designing, manufacturing and commercialization of medical devices or products
7+ years experience managing design of medical device projects and leading teams
A closely involved engineering person with the proven ability to work well in a team environment
Demonstrated expertise in all phases of the product development lifecycle
Experience navigating medical device risk analysis
Bachelor of Science in Mechanical Engineering (BSME) or equivalent engineering degree and/or a MS or PhD preferred

Nice To Haves

Class II medical product experience
Experience with FDA regulations and medical device design control
Working knowledge and experience designing for sterilization and re-processing standards and requirements
Organizational skills and ability to work on several fast-paced projects simultaneously
Ability to interact effectively with a wide variety of people and departments
Effective communication and documentation skills
Proven ability to motivate, guide, and inspire members of core and extended project teams
Proven knowledge of engineering fundamentals
Experience in studying tradeoffs between product features, customer needs/requirements, producibility, and cost
Planning, decision-making and negotiation
Expertise in evaluating and selecting patient-contacting and implantable medical device materials
Knowledge of Design Control processes for medical devices
Proven ability to Seek, recognize, and execute clever and simple solutions to resolve complex department challenges

Responsibilities

Set long-term strategic vision aligning team goals with business priorities
Develop and manage the Instruments and Accessories team, focusing on culture, hiring, and retention
Define performance expectations and ensure effective communication across all team levels
Oversee project planning, budgeting, and resource allocation for operational excellence
Advocate relationship building and handoffs between new product development and manufacturing/NPI
Engage collaborators to ensure product engineering project priorities and help for long-term goals
Anticipate roadblocks and remove silos for seamless execution of priorities