Director, Design Engineering, Cardiac Product Development

Socket.dev; Sunnyvale (CA); On-site; USD 300,000 - 420,000; Full time

Job summary

Intuitive Surgical seeks a Director of Cardiac Product Development to lead cross-functional teams delivering a portfolio of cardiac instruments and accessories for the da Vinci system. You will manage an organization of design engineers, report to senior design leadership, and collaborate with regulatory, PMO, and product management to create roadmaps.

The role emphasizes executing multiple concurrent development programs, sustaining engineering, and driving high-quality, customer-focused

Qualifications

• B.S. in Mechanical Engineering, Biomedical Engineering, or related engineering field.
• At least 12 years of experience developing medical products or related R&D experience.
• At least 5 years of experience as a people manager and managing managers.
• Experience with design control (ISO 13485) and risk management (ISO 14971).
• Experience developing surgical or interventional medical devices for cardiovascular disease.
• Mechanical design of small, precision medical devices with strong engineering fundamentals.

Responsibilities

• Set long-term strategic vision and align team goals with business objectives.
• Grow and manage an organization of design engineers for cardiac instrument and accessory products.
• Oversee product development across full lifecycle including feasibility, NPD, and sustaining engineering.
• Address product quality, cost, and supply chain issues with cross-functional teams.
• Translate customer needs and business strategy into detailed plans with senior leaders.

Skills

People management

Cross-functional leadership

Design control ISO 13485

Risk management ISO 14971

Medical device development

Mechanical design of small devices

Project planning and roadmaps

Budgeting and resource planning

Regulatory collaboration

Strategic vision

Education

B.S. in Mechanical/Biomedical Eng or related field

M.S. or Ph.D. in Mechanical Engineering (preferred)

Job description

Primary Function of Position

The Director of Cardiac Product Development leads cross functional product development teams to develop a portfolio of instrument and accessory products that enable cardiac surgery with the da Vinci system. They also directly manage an organization of instrument and accessory design engineers. This role reports to the VP of Design Engineering for Instruments & Accessories and has \"dotted line\" reporting to the corporate VP for cardiac surgery (cardiac business unit lead).

The Director is responsible for ensuring new instrument and accessory product development efforts support Intuitive's strategy for cardiac surgery, and that product development teams execute to deliver the needed portfolio of cardiac products. The scope of responsibility includes new product development (NPD) programs as well as early-stage feasibility efforts and sustaining engineering for products on the market. Responsibilities of the role include growing, developing, and operating a team capable of executing multiple cross-functional product development efforts running concurrently. The Director has technical depth and leadership skills to ensure product development teams deliver high quality products that meet both customer needs and business objectives.

Essential Job Duties

• Setting long-term strategic vision, aligning team goals with business objectives


• Growing, developing, and managing an organization of design engineers supporting a portfolio of cardiac instrument and accessory products


• Managing a team of people managers with responsibility for product development activities through the entire product lifecycle, including early exploration and feasibility, new product development, and sustaining engineering.


• Creating teams to address product quality, cost, and supply chain issues as needed


• Translating customer needs and business strategies into detailed organizational and product development plans in collaboration with senior management and cross-functional stakeholders


• Setting goals for their organization, aligned with business and corporate strategy. Informing and shaping cardiac business unit strategy and goals.


• Collaborating with other key functions such as regulatory affairs, product management, and PMO to create product roadmaps and project plans that address customer and business needs


• Working cross-functionally and anticipating and mitigating challenges to ensure on-time delivery of innovative, high-quality products that meet the needs of customers


• Communicating directly with senior executives at the company on product development plans and status


• Championing design innovation and creation of intellectual property


• Ensuring Intuitive's product development processes are effectively applied to cardiac instrument and accessory programs and advancing those processes to support Intuitive's business needs

Required Skills and Experience

• B.S. degree in Mechanical Engineering, Biomedical Engineering, or related engineering field


• At least 12 years of experience developing medical products or other relevant R&D experience


• At least 5 years of experience as a people manager and experience managing managers


• Skilled in all phases of medical device product development processes, including design control (ISO 13485) and risk management (ISO 14971)


• Experience developing surgical or interventional medical devices for treatment of cardiovascular disease


• Skilled and experienced in mechanical design of small, precision medical devices. Able to apply engineering fundamentals to ensure high quality output by their team.


• Effective hiring and personnel performance management


• Experienced in organizational design of product development teams


• Ability to manage through managers


• Ability to lead cross-functionally, including building alignment, resolving conflicts, and removing roadblocks

Nice to have:

• Able to develop highly capable leaders and product development teams


• Selfless leader who inspires trust and commitment within the team and with key stakeholders through integrity, passion, and professional excellence


• Ability to develop budgets and other resource plans for their organization and for large cross-functional teams/programs


• Able to drive, manage, and navigate change within their team and across the cardiac product development organization


• Ability to communicate effectively to audiences ranging from individual contributors to senior stakeholders within the company and outside the company


• Understanding of business concepts including finance and business operations to inform decision making and problem solving


• Simulated and real operating room environments

Travel:

• Ability to travel up to 15%

Preferred Skills and Experience

• M.S. or Ph.D. in Mechanical Engineering or related field


• Experience developing products with software-controlled electro-mechanical (robotic) systems


• Advanced laparoscopic instrument design


• Class III medical device development

Due to the nature of our business and the role, please note that Intuitive and/or your customer(s) may require that you show current proof of vaccination against certain diseases including COVID-19. Details can vary by role.

Intuitive is an Equal Opportunity Employer.We provide equal employment opportunities to all qualified applicants and employees, and prohibit discrimination and harassment of any type, without regard to race, sex, pregnancy, sexual orientation, gender identity, national origin, color, age, religion, protected veteran or disability status, genetic information or any other status protected under federal, state, or local applicable laws.

Mandatory Notices

U.S. Export Controls Disclaimer:In accordance with the U.S. Export Administration Regulations (15 CFR §743.13(b)), some roles at Intuitive Surgical may be subject to U.S. export controls for prospective employeeswho are nationals from countries currently on embargo or sanctions status.

Certain information you provide as part of the application will be used for purposes of determining whether Intuitive Surgical will need to (i) obtain an export license from the U.S. Government on your behalf (note: the government's licensing process can take 3 to 6+ months) or (ii) implement a Technology Control Plan (\"TCP\") (note: typically adds 2 weeks to the hiring process).

For any Intuitive role subject to export controls, final offers are contingent upon obtaining an approved export license and/or an executed TCP prior to the prospective employee’sstart date, which may or may not be flexible, and within a timeframe that does not unreasonably impede the hiring need. If applicable, candidates will be notified and instructed on any requirements for these purposes.

We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.

Preference will be given to qualified candidates who do not reside, or plan to reside, in Alabama, Arkansas, Delaware, Florida, Indiana, Iowa, Louisiana, Maryland, Mississippi, Missouri, Oklahoma, Pennsylvania, South Carolina, or Tennessee.

This position may be filled at a different job level than listed here dependingbusiness need and/or on the selected candidate’s experience, knowledge and skills.Compensation will be based primarily on the job level at which the role is filled and thecandidate’s qualifications, consistent with applicable law..

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.

It started with a simple idea: what if surgery could be less invasive and recovery less painful? Nearly 30 years later, that question still fuels everything we do at Intuitive. As a global leader in robotic-assisted surgery and minimally invasive care, our technologies—like the da Vinci surgical system and Ion-have transformed how care is delivered for millions of patients worldwide.

We’re a team of engineers, clinicians, and innovators united by one purpose: to make surgery smarter, safer, and more human. Every day, our work helps care teams perform with greater precision and patients recover faster, improving outcomes around the world.

The problems we solve demand creativity, rigor, and collaboration. The work is challenging, but deeply meaningful- because every improvement we make has the potential to change a life.

If you’re ready to contribute to something bigger than yourself and help transform the future of healthcare, you’ll find your purpose here.