Senior Manager, Instruments

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.

- 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

- 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

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.

Required Skills and Experience

• 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 Primary Function of 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.

• 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