Director, Instruments and Accessories

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.

- 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

- 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

- 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

We provide market-competitive compensation packages, inclusive of base pay, incentives, benefits, and equity. It would not be typical for someone to be hired at the top end of range for the role, as actual pay will be determined based on several factors, including experience, skills, and qualifications. The target compensation ranges are listed.

Qualifications

• 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

• 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 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.

• 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