Quality Engineer | JobSetuu

Description

Job Overview

• Source: Jobicy

Job Description

Unternehmensbeschreibung

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 leading company in the field of 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.

Stellenbeschreibung

Primary Function of Position:

Intuitive seeks a strong technical contributor who can help define practical, useful quality metrics and specifications, identify key opportunities for product improvement, launch quality initiatives, lead projects to implement these initiatives, and serve as an expert consultant to help solve the most technically challenging quality problems. The ideal candidate possesses a broad base of experience and a high level of technical depth in at least two technical specialties applicable to medical robotics and optics, and is equally at home in the test lab, on the manufacturing shopfloor and providing technical leadership to our team as we develop standard practices of our organization. You will not abide “process red tape”, instead passionately seeking the most efficient way to build in product quality. And you will also coach, mentor, teach, and influence the engineering staff in best quality practices, data analysis, protocol development, and design for quality and reliability methods.

Roles and Responsibilities:

• New Product Development and Sustaining/Manufacturing Support
  • Handle projects of various product and subsystem/component types (electrical, mechanical, optical, etc).
  • Develop measurable goals for quality and lead Quality Table meetings.
  • Ensuring that the essential performance aspects are mitigated in the product quality plans.
  • Identify critical elements of designs. Recommend design processes and methods to meet quality goals: DFX, etc.
  • Provide guidance to other engineers regarding applicable regulatory and statutory requirements and the applicability of these requirements to the ISI products.
  • Plan and create quality standards, quality control, and quality assurance procedures, plans, test methods, fixtures, and processes for incoming materials and finished devices.
  • Ensure process compliance through the design and development of comprehensive procedures including work instructions, flowcharts, forms, templates, checklists, and other product or process related documentation, for recording, evaluating, and reporting quality data.
  • Analyze and disposition of discrepant material.
  • Support manufacturing processes, including failure analysis, documentation review and approval, tooling qualification, inspection method qualification, and defect containments.
  • Support development and execution of process validation and verification test plans, protocols, and reports.
  • Support development and execution of manufacturing line qualification plans, protocols, and reports. Support and drive MVP/R projects.
• Failure Analysis
  • Provide quality expertise to the quality engineering support team to analyze the product failure.
  • Perform deep technical failure analysis based on the physics of failure.
  • Review and interpret complex data analysis rooted in an understanding of our product hardware and software, the physics of failure, and the use conditions in the clinical / operating room environment.
• Quality Advocacy and Project Management
  • Create, process and review various types of Quality Notifications and Change Orders.
  • Develop and apply corporate level quality metrics. Lead quality meetings e.g. QDR (Quality Data Review).
  • Lead and project manage quality initiatives in one or more of these focus areas: Product Quality, Data Quality, Process Quality.
  • Perform mock audits and Gemba walks to ensure compliance with ISI QMS.
    Participate in audits (front/back room).
• Develop, lead and communicate intercompany Quality Engineering projects.

Qualifikationen

Required Knowledge, Skills, and Experience:

• Bachelor’s degree in electrical, mechanical or system engineering, math, or physics. Advanced degree preferred.
• 5+ years of working experience in Quality Engineering or Process Engineering with quality improvement projects participation, minimum 3 years in medical device design or manufacturing environment.
• Able to navigate quality and compliance system with minimal oversight on individual projects.
• Demonstrated understanding of CFR 21 820/ ISO 13485 requirements for making process or design changes.
• Understands product risk management, experience in generate FMEA and process FMEA.
• Understands Design Controls, Change Controls, Product, and Engineering Processes.
• Proficient with generate and execute Qualification and Validation protocols and Quality Assurance Procedures.
• Experienced in leading product containment and rework activities.
• Proficient in SPC & Six Sigma methodology and tools.
• Experienced in typical Excel data analysis operations. Able to create Multi-source report, trends, and interprets data with minimal oversight.
• Capable of thinking independently and make decision based on limited information.
• Capable of initiating improvement discussion and lead the team toward the goal.
• Can present information in various forms and forums, collaborates with peers across functions. Experience in presenting to cross functional mgmt. communications. (e.g. report writing, presentations, QRB presenter).
• Excellent creative problem-solving skills.
• Excellent communication and documentation skills in English and German.

Zusätzliche Informationen

Wir schätzen jede Person in ihrer Individualität – unabhängig von Geschlecht, ethnischer oder sozialer Herkunft, Religion, besonderen Bedürfnissen, Alter oder sexueller Identität. Diskriminierung hat bei uns keinen Platz.

Haftungsausschluss für US-Exportkontrollen: In Übereinstimmung mit den U.S. Export Administration Regulations (15 CFR §743.13(b)) können einige Positionen bei Intuitive Surgical US-Exportkontrollen für potenzielle Mitarbeitende unterliegen, die Staatsangehörige von Ländern sind, die derzeit einen Embargo- oder Sanktionsstatus haben.

Bestimmte Informationen, die Sie im Rahmen der Bewerbung angeben, werden verwendet, um festzustellen, ob Intuitive Surgical (i) in Ihrem Namen eine Exportlizenz von der US-Regierung einholen muss (das Lizenzierungsverfahren der Regierung kann bis zu sechs Monate dauern) oder (ii) einen Technology Control Plan (TCP) implementieren muss (verlängert den Einstellungsprozess in der Regel um 2 Wochen).

Für alle Positionen bei Intuitive, die Exportkontrollen unterliegen, steht ein endgültiges Angebot unter dem Vorbehalt, dass vor dem geplanten Eintrittsdatum eine genehmigte Exportlizenz und/oder ein vollständig ausgeführter Technology Control Plan (TCP) vorliegt. Das Eintrittsdatum kann dabei angepasst werden, sofern der Genehmigungsprozess den Einstellungsbedarf nicht unangemessen beeinträchtigt.

Diese Position kann abhängig von den betrieblichen Anforderungen und/oder der Erfahrung der ausgewählten Kandidatin bzw. des ausgewählten Kandidaten auf einer anderen Jobstufe als hier angegeben besetzt werden. Die Vergütung richtet sich nach der Jobstufe sowie der Qualifikationen der Kandidatin bzw. des Kandidaten, selbstverständlich unter Berücksichtigung aller gesetzlichen Vorgaben.

Expert Career Tips for Quality Engineer Roles

To succeed in a competitive market as a Quality Engineer, you need more than just technical skills. Here are some expert strategies to elevate your profile:

• Build a Strong Portfolio: For technical roles, a clean GitHub or a personal project site is essential. For non-technical roles, a case study portfolio demonstrating problem-solving and impact is equally valuable. Show, don't just tell, what you have achieved in your previous positions.
• Master the Narrative: When interviewing, use the STAR method (Situation, Task, Action, Result) to structure your answers. Quantify your results wherever possible—mentioning "increased efficiency by 20%" is much more impactful than saying "improved efficiency."
• Continuous Learning: The industry moves fast. Whether it's staying updated with the latest AI tools or mastering a new management methodology, continuous professional development is key. Consider obtaining industry-recognized certifications that align with Quality Engineer requirements.
• Networking: Connect with other professionals in similar roles. Join online communities, attend webinars, and engage in meaningful discussions on professional social networks. Often, the best opportunities come through referrals and community engagement.
• Soft Skills Matter: Communication, empathy, and leadership are often the deciding factors between two equally qualified technical candidates. Cultivate these skills as they are universally valued across all industries and seniority levels.

Additionally, research the specific company's culture and values. Tailoring your application to show how you align with their mission can significantly increase your chances of moving forward in the process.

Salary & Compensation

Salary not disclosed; typically competitive for the role.

Work Arrangement

Type: On-Site

Standard business hours at the office.

Comprehensive Application Strategy & Hiring Process

Applying for a new role is a marathon, not a sprint. Follow this strategic approach to maximize your success rate:

1. Initial Research & Tailoring

Don't send the same resume to every employer. Spend at least 30 minutes researching the company. Look for recent news, their product roadmap, and their team structure. Modify your summary and core competencies to reflect the specific keywords found in the job description.

2. The Perfect Cover Letter

If the application allows for a cover letter, use it to tell a story that your resume cannot. Explain why you are passionate about this specific company and how your unique background makes you the perfect fit for the challenges they are currently facing.

3. Navigating the Multi-Stage Interview

Most modern hiring processes involve 3-5 stages. This typically includes a recruiter screen, a technical or skill-based assessment, a peer interview, and a final leadership round. Prepare for each stage differently: focus on enthusiasm and fit for the recruiter, technical depth for the assessment, and strategic vision for the leadership round.

4. Post-Interview Follow-Up

Always send a personalized thank-you note within 24 hours of each interview. Reference a specific topic discussed during the call to demonstrate your active listening and genuine interest in the role.

By following these steps, you demonstrate a high level of professionalism and attention to detail that sets you apart from the average applicant.

Typical Interview Process

1. Resume screening
2. HR call
3. Skill interview
4. Final manager interview
5. Offer

Tip: Research the company's products and culture.

Global Market Intelligence & Relocation Insights

At JobSetuu, we specialize in helping talent navigate the global job market. Here is what you need to know about the current landscape in Global and beyond:

The demand for skilled professionals is increasingly borderless. For roles based in Global, understanding the local cost of living, visa requirements (if applicable), and cultural nuances is vital. If this is a remote role, consider the time zone alignment and the asynchronous communication culture of the hiring organization.

Relocation Support: Many forward-thinking companies offer relocation packages that include moving stipends, temporary housing, and legal assistance with work permits. When evaluating an offer, look beyond the base salary—consider the total compensation package, including equity, bonuses, and healthcare benefits.

Work-Life Balance Trends: Hybrid and remote work have become standard in many regions. Research the local labor laws and common practices regarding work hours and vacation time to ensure the role aligns with your lifestyle goals.

Leveraging JobSetuu's tools can help you compare salaries across different cities and understand the "purchasing power" of your potential offer, ensuring you make an informed decision for your long-term career path.

Skills & Competency Roadmap for Professional Development

To remain competitive in Professional Development, we recommend focusing on the following core competencies over the next 12-18 months:

• Technical Mastery: Deepen your expertise in the core tools and languages relevant to your field. For developers, this might be cloud architecture; for marketers, it might be data-driven attribution modeling.
• AI Augmentation: Learn how to leverage generative AI and automation tools to increase your productivity. Understanding how to integrate these technologies into your workflow is becoming a non-negotiable skill.
• Leadership & Strategy: Even in individual contributor roles, the ability to think strategically and lead projects from inception to completion is highly valued. Focus on stakeholder management and high-level project planning.
• Data Literacy: The ability to interpret data and use it to drive decisions is essential across all business functions. Familiarize yourself with data visualization and basic analytical concepts.

By investing in these areas, you not only prepare yourself for the role you are applying for today but also build a resilient foundation for the opportunities of tomorrow.

Apply via JobSetuu

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