Design Control Process Leader

Intuitive

3.5

(6)

Sunnyvale, CA

Why you should apply for a job to Intuitive:

  • 80% say the CEO supports gender diversity
  • Ratings are based on anonymous reviews by Fairygodboss members.
  • Lyra mental health benefit provides up to 12 free therapy sessions annually for employees and their dependents
  • Time away to take care of your newborn, the total time varies by country
  • Equity in the company in the form of a cash bonus or restricted stock depending on your county and role to help you grow your finances
  • #JOB5802

    Position summary

    s.
    Passionate people who want to make a difference drive our culture. Our team members are grounded in integrity, have a strong capacity to learn, the energy to get things done, and bring diverse, real world experiences to help us think in new ways. We actively invest in our team members to support their long-term growth so they can continue to advance our mission and achieve their highest potential.
    Join a team committed to taking big leaps forward for a global community of healthcare professionals and their patients. Together, let's advance the world of minimally invasive care.
    Job Description

    Primary Function:

    • Accountable for Quality Improvement Project (QIP) completion and ongoing sustainment and improvement of Design Control processes and procedures to ensure scalability and effectiveness.

    • Drives efforts to finalize the new process

    • Work with the Business Units (BU) to develop the strategic roadmap for processes and procedures continuous improvement, drive the development and implementation plan, secure resources, and complete projects.

    • Define long-term accountabilities and serve as business manager for Design Control.

    • Oversee updates of SOPs, Instructions, or business processes and associated training plans.

    • Is the SME for Design Control. Represent Intuitive during Internal and External Audits. Will be the owner of any associated audit findings in Design Control.

    • Accountable for Design Control QMS processes.

    • Guides Design Control working team; heads a cross-BU team of stakeholders through influence.

    • Has formal reporting responsibilities to VP Product Quality and dotted reporting relationships to Design Engineering, Supplier Engineering, Regulatory Affairs and others.

    Roles and Responsibilities:

    Process Improvement and Scalability:

    • Continuously evaluate and optimize Design Control processes to enhance efficiency and effectiveness, especially as our business grows.

    • Identify areas for improvement through process audits, feedback collection, and data analysis.

    • Implement standardized work instructions and best practices to ensure consistent and streamlined execution across business units and global locations.

    • Leverage automation tools and technologies to improve process efficiency and scalability.

    • Foster a culture of continuous improvement by encouraging employee involvement and feedback in process enhancement initiatives.

    Compliance:

    • Serve as primary accountable person for Design Control and act as the representative during audits of Design Control.

    • Stay updated on relevant regulations and industry standards. Take proactive measures to ensure and improve our compliance with Design Contro lrequirements.

    • Manage curriculum-based training program for Design ControlEvaluate and enhance the effectiveness of the training program to ensure that all affected teams have the necessary knowledge and skills to perform their work successfully.

    Design Control Governance:

    • Head the Design Controls the Process Owner. Work with stakeholders from business units and relevant cross-functional partners.

    • Develop and maintain documentation outlining the governance structure, processes, and key performance indicators.

    • Develop a plan for the future state of the Design Control governance model. The process owner will also be accountable for this plan post implementation.

    • Manage a board representative of functional people (DE, SE, PQ, Reg, etc.).

    • Implement regular communication channels and meetings to ensure effective collaboration and agile decision-making.

    Additional Accountabilities:

    • Oversee QMS changes. Identify, maintain, and coordinate review and approval of changes.
    • Review / Approve all Design Control QMS documents.
    • Maintain the Approval Groups in Agile
    • Create a QMS roadmap that includes infrastructure needs (e.g., IT tools).
    • Manage budget and headcount requests for these projects.
    • Collaborate with other Design Control Process Owners to ensure effective QMS alignment and coordinate high-impact QMS changes across workstreams.
    • Represent team in project team to implement system-level improvements.

    Qualifications

    Skill/Job Requirements:

    • Minimum BS in Engineering, Master's preferred
    • A minimum 15+ years' experience in the relevant subject matter.
    • A minimum 8+ years of medical device experience.
    • Has successfully led multiple change management and transformation projects with effective rollout and training of new processes and procedures.
    • Experience in resolving audit findings and completing CAPAs.
    • Have deep knowledge of medical device regulations.
    • Experienced in launching and maintaining medical device products.
    • 20% domestic/international travel needed.

    Additional Information

    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 Employment 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.

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

    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 salary ranges are listed.

    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 Employment 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.

    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.

    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 salary ranges are listed.

    Base Salary Range Region 1: $189,600 USD - $284,400 USD
    Base Salary Range Region 2: $161,200 USD - $241,800 USD
    Shift: Day
    Travel: 25% of the time
    Workplace Type: Set Schedule - This job will be onsite weekly, the percentage of onsite work will be defined by the leader.

    Why you should apply for a job to Intuitive:

  • 80% say the CEO supports gender diversity
  • Ratings are based on anonymous reviews by Fairygodboss members.
  • Lyra mental health benefit provides up to 12 free therapy sessions annually for employees and their dependents
  • Time away to take care of your newborn, the total time varies by country
  • Equity in the company in the form of a cash bonus or restricted stock depending on your county and role to help you grow your finances