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Staff Hardware Test Engineer

Company Description

At Intuitive, we are united behind our mission: we believe that minimally invasive care is life-enhancing care. Through ingenuity and intelligent technology, we expand the potential of physicians to heal without constraints.
As a pioneer and market leader in robotic-assisted surgery, we strive to foster an inclusive and diverse team, committed to making a difference. For more than 25 years, we have worked with hospitals and care teams around the world to help solve some of healthcare's hardest challenges and advance what is possible.
Intuitive has been built by the efforts of great people from diverse backgrounds. We believe great ideas can come from anywhere. We strive to foster an inclusive culture built around diversity of thought and mutual respect. We lead with inclusion and empower our team members to do their best work as their most authentic selves.
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 of the Position

The New Product Verification Department is devoted to assuring safe, reliable, and effective products that exceed patient, surgeon, and hospital expectations. The department plays a vital role in product and process quality, in new product development and production, and in the quality of da Vinci and Ion robotic product lines, including diagnostic systems, endoscopic instrumentation, and supporting accessories. The Senior Test Engineer will work with a team of dedicated people within a product development team to assure the quality of new designs, to identify issues related to new designs and processes, and to work with other Test Engineers to develop harmonized test methods.

Essential Job Duties

Test Protocol Development, Execution & Reporting

  • Develops high level test plans for instrument, accessories, endoluminal, and vision projects
  • Generates and takes ownership of test protocols for Design Verification and Life/ Reliability tests
  • Develops clinically relevant test methods ensure design requirements are sufficiently verified by collaborating with appropriate cross functional partners
  • Executes test protocols for clinically-based surgical simulation and automated testing utilizing da Vinci surgical system, Ion Systems and/or other test equipment
  • Identifies, reports and negotiate problems that arise during feasibility and design verification testing, and escalates new or persistent failure modes to appropriate engineering teams
  • Drives failure investigation and root cause analysis in collaboration with other engineering partners
  • Clearly documents test results and observations in test report.

Test Fixture Development:

  • Designs test fixtures and other test aids needed to perform Design Verification and Life/ Reliability tests
  • Proactively identifies and develops processes and test methods that could benefit from new or updated fixture designs by engaging with design and test engineers

Reasoning Ability:

  • Ability to apply critical thinking to solve problems while leading cross-functional, technical teams in making recommendations.
  • Ability to influence technical stake holders and suggest process improvements
  • Ability to understand and work on complex products and processes

Other Responsibilities

  • Technical leadership when collaborating with the cross functional teams and contributes to the development of product requirements and risk documents
  • Effective technical communication across various levels of the organization at core team meetings and design reviews.
  • Ensures successful, on-time completion of department and core team projects; communicates constraints and recommends preferred mitigation to direct management when successful project completion is at risk
  • Complies with company Department and Standard Operating Procedures
  • Contributes to the strategy for reliability assessment and verification of robotic surgical devices.
  • Effectively translate the functional requirements into appropriate acceptance criteria for testcases and test methods.
  • Coaches and mentors engineers and technicians in the team

Qualifications

Required Skills and Experience

  • Medical Device Verification/Validation experience is required
  • Understanding of design controls used in the Medical device development is required.
  • Experience with working on through various phases of medical device product development process (concept through launch) is required.
  • Ability to perform mechanical engineering calculations needed to support equipment design, including dimensional analysis.
  • Experience using tools and measuring equipment (Force Gauge, Calipers, Instron, Oscilloscopes etc.).
  • Ability to work autonomously and with minimal supervision.
  • Ability to multitask, and handle tasks with contesting priorities effectively.
  • Ability to work with biological samples, including blood, tissue and organs.
  • Familiar with GDP skills.
  • Accepting and adhering to high ethical, moral, and personal values in decisions, communications, actions, and when dealing with others

Required Education and Training

  • Minimum 10+ years experience working in an engineering organization.
  • Minimum BS in Mechanical, Biomedical Engineering or similar degree. MS preferred.

Working Conditions

  • The employee will spend time at their desk in front of the computer as well as work in a lab environment.
  • Lab environment will have exposure to animal blood and tissue; there will also be exposure to detergents and other chemicals used for reprocessing medical devices.
  • Hands on testing includes but not limited to using the robotic systems, mechanical test fixtures, microscopes, electrical test fixtures etc.

Preferred Skills and Experience

  • Prefer experience within medical device or pharmaceutical industry.
  • Experience with SolidWorks or similar CAD software.
  • Experience with MATLAB, Python, Arduino is highly preferred.
  • Experience working with electro-mechanical systems is a plus.
  • Experience with Test Method Validation is highly preferred.
  • Experience in Reliability Engineering is a plus.

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 / Affirmative Action 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.

EEO and AA Policy

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.

Average salary estimate

$115000 / YEARLY (est.)
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$100000K
$130000K

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What You Should Know About Staff Hardware Test Engineer, Intuitive

Are you a seasoned Staff Hardware Test Engineer looking for an opportunity to make a meaningful impact? Join the passionate team at Intuitive in Orange, CT, where we believe that minimally invasive care enhances lives. As a pioneer in robotic-assisted surgery, our mission is to empower healthcare professionals through intelligent technology and innovative design. In the role of Staff Hardware Test Engineer, you’ll play a crucial part in our New Product Verification Department, ensuring our da Vinci and Ion robotic product lines provide exceptional quality and safety. You'll engage in the development and execution of comprehensive test protocols, collaborate with cross-functional teams, and design innovative test fixtures to elevate our medical devices. Your expertise will help identify potential issues and drive solutions during the product development lifecycle. We foster an inclusive environment where your ideas and contributions are valued, and you’ll have the chance to coach and mentor fellow engineers. Here at Intuitive, you won't just be testing products—you'll be making strides in healthcare, enhancing lives one innovation at a time. If you're ready to bring your ten years of engineering experience and passion for quality to a team that's dedicated to transforming healthcare, we encourage you to apply and join us in advancing the world of minimally invasive care.

Frequently Asked Questions (FAQs) for Staff Hardware Test Engineer Role at Intuitive
What are the primary responsibilities of a Staff Hardware Test Engineer at Intuitive?

The Staff Hardware Test Engineer at Intuitive is responsible for developing high-level test plans, generating and executing test protocols for design verification, and conducting life/reliability tests. They also troubleshoot and collaborate with cross-functional teams to address any issues that arise during testing, ensuring that our robotic products exceed industry standards.

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What qualifications are required to become a Staff Hardware Test Engineer at Intuitive?

To qualify as a Staff Hardware Test Engineer at Intuitive, candidates must possess at least a BS in Mechanical or Biomedical Engineering, with an MS preferred. A minimum of 10 years of experience in an engineering organization, particularly in medical device verification and validation, is essential. Familiarity with design controls and experience using measuring equipment are also required.

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What skills are beneficial for a Staff Hardware Test Engineer at Intuitive?

In addition to the basic qualifications, a Staff Hardware Test Engineer at Intuitive would benefit from experience with SolidWorks or similar CAD software, programming skills in MATLAB or Python, and hands-on experience with electro-mechanical systems. The ability to lead cross-functional teams and apply critical thinking in problem-solving is also highly advantageous.

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How does Intuitive support the growth and development of its Staff Hardware Test Engineers?

Intuitive is committed to fostering an inclusive culture that encourages personal and professional growth. Staff Hardware Test Engineers benefit from ongoing training and development opportunities, mentorship from senior engineers, and the chance to work on innovative projects that push the boundaries of robotics in healthcare.

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What is the work environment like for a Staff Hardware Test Engineer at Intuitive?

The work environment for a Staff Hardware Test Engineer at Intuitive includes both office-based tasks and hands-on laboratory work. Engineers may encounter various biological samples and should adhere to strict safety protocols while working with sophisticated robotics and testing equipment.

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Common Interview Questions for Staff Hardware Test Engineer
Can you describe your experience with medical device verification and validation?

In your response, focus on specific projects where you implemented verification and validation processes. Highlight your role in developing test protocols and ensuring compliance with regulatory standards, emphasizing any challenges you overcame.

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How do you approach developing test protocols for new medical devices?

Discuss your methodology for identifying design requirements and collaborating with cross-functional teams. Highlight your experience with clinically relevant test methods and how you ensure comprehensive testing that meets safety and reliability standards.

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Explain the importance of root cause analysis in hardware testing.

Root cause analysis is critical in hardware testing as it helps identify fundamental issues that can lead to product failures. Emphasize your experience in conducting thorough investigations and how this process contributes to improved product quality and safety.

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Describe a time you had to lead a cross-functional team in a testing project.

Share a specific example where you took charge, focusing on your leadership style and how you coordinated efforts between various teams. Highlight how effective communication and collaboration led to the successful completion of the project.

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What tools and methods do you utilize when conducting mechanical engineering calculations?

Discuss specific tools you are proficient in, such as software or measuring devices. Provide examples of calculations you've performed to support equipment design and how these ensure the reliability and functionality of medical devices.

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How do you ensure compliance with industry regulations during the testing process?

Share your familiarity with regulatory standards and how you incorporate compliance checks throughout your testing process. Mention specific practices you follow to maintain adherence to quality assurance protocols.

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What challenges have you faced while testing robotic systems, and how did you overcome them?

Describe a particular challenge, the steps you took to address it, and what you learned from the experience. This shows your problem-solving skills and resilience in a high-stakes testing environment.

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How do you balance the demands of multiple projects with competing priorities?

Outline your strategies for prioritizing tasks and managing your time effectively. Mention any project management techniques or tools you use to keep organized and ensure timely results across various projects.

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What are your thoughts on the future of robotic-assisted surgery and its impact on healthcare?

Provide a forward-thinking perspective on advancements in the field. Discuss how you believe robotic-assisted surgery will evolve and its implications for patient outcomes and healthcare efficiency, drawing on your experience and insights from working in the industry.

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How would you mentor a junior engineer on your team?

Talk about your approach to mentorship, emphasizing your commitment to fostering growth through guidance and support. Provide examples of how you've successfully coached others, ensuring they develop the necessary skills and confidence to excel.

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Founded in 1995, Intuitive Surgical, Inc develops, manufactures and markets robotic technologies designed to improve clinical outcomes and help patients return more quickly to active and productive lives. The company is headquartered in Sunnyvale,...

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Full-time, on-site
DATE POSTED
December 16, 2024

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