Search for Manager roles in Failure Investigation Engineering in Pleasanton, CA, with at least 8 years of experience in the medical device industry, focusing on quality management systems and post-market surveillance.

Okay, I've searched for Manager roles in Failure Investigation Engineering located in Pleasanton, CA, requiring at least 8 years of experience in the medical device industry with a focus on quality management systems and post-market surveillance. I have found 45 relevant positions for you.

Manager, Failure Investigation Engineering

Pleasanton, CA

8 years + Experience

Medical Devices

Manager

Can you help me to analyze the job description and company culture?

Sure. Here's the analysis:

Job Analysis:

The Manager, Failure Investigation Engineering at Calyxo, Inc. is fundamentally tasked with ensuring the integrity and reliability of medical devices through thorough investigations into complaints and adverse events. This role requires a strong leader who can manage a team of engineers and technicians effectively while maintaining high standards of investigation and documentation. Key responsibilities include leading thorough investigations into failure modes, collaborating with various departments to analyze root causes, and ensuring compliance with stringent regulatory standards. The ideal candidate will face challenges such as balancing multiple projects, navigating complex regulatory landscapes, and fostering effective cross-functional collaboration. Success in this role will be measured by the accuracy and timeliness of investigation outcomes, the quality of team development, and the proactive identification of trends that could inform product improvements or risk mitigation strategies. Overall, this position requires not only technical expertise but also exceptional leadership and communication skills to drive the team's success.

Company Analysis:

Calyxo, Inc. operates within the medical device industry, focusing specifically on improving treatment for kidney stones. As a relatively young company founded in 2016, it positions itself as an innovator in a niche yet critical area of healthcare, indicating a growth-oriented mindset aimed at addressing significant medical needs. The company culture emphasizes collaboration, transparency, and high achievement, reflecting its commitment to F.I.T to WIN values. With a dynamic team that prioritizes fun and diversity, prospective candidates can expect an environment that champions continuous learning and a strong sense of community. The role of Manager, Failure Investigation Engineering is positioned to have substantial influence, as it requires direct teamwork with various departments—ensuring a collaborative effort toward quality and patient safety. Strategically, this hire is essential for scaling operations and enhancing product reliability, aligning with Calyxo’s larger vision of revolutionizing kidney stone treatment through high-quality medical devices.

Mock up some interview questions based on the job description.

Absolutely. Here are some mock interview questions that could come up:

Can you describe a situation where you led a team to resolve a complex product failure? What were your strategies and the outcomes?
Tell me about a time you had to comply with regulatory standards in a project. How did you ensure compliance throughout the process?
Describe a challenging complaint investigation you managed. What steps did you take to ensure thoroughness and accuracy?
How do you motivate and develop team members in a high-pressure environment?
What specific investigation tools or methodologies have you used in past roles, and how did they contribute to your success?
Can you walk us through your process for analyzing product complaints? What key factors do you consider?
Imagine you discover a new failure mode that has not been previously reported. What steps would you take to investigate and address this issue?
Suppose there’s a significant trend emerging from complaint data that could indicate a risk to patients. How would you approach the situation?
Why are you interested in working at Calyxo specifically, given its mission and values?
How do your personal values align with Calyxo's core values of finding joy, integrity, transparency, and teamwork?
What do you see as the biggest challenge in failure investigation engineering today, and how would you approach it?
What questions do you have regarding Calyxo's commitment to innovation in kidney stone treatment?
How would you assess the effectiveness of a failure investigation procedure? What metrics would you consider?
Can you describe how you would handle disagreement among team members during the investigation process?

Job Details

Overview Company

Manager, Failure Investigation Engineering

$150k/y-$170k/y

Calyxo, Inc.

2 days ago

Highlight

OnsiteFull-time8+ yearsSenior

Summary

Calyxo, Inc. is seeking a Manager, Failure Investigation Engineering to join their team in Pleasanton, CA. The role involves leading a team responsible for investigating, analyzing, and resolving product complaints and ensuring timely processing of adverse event reporting.

About the Role

As a Manager, Failure Investigation Engineering, you will manage a team of investigators, engineers, and technicians, oversee daily complaint investigations, and ensure accurate documentation and reporting. You will collaborate with cross-functional teams such as Medical Affairs, Regulatory, Operations, Customer Service, and R&D. Responsibilities include training team members, managing investigation labs, participating in quality audits, and contributing to a culture of collaboration and excellence.

About You

Required:

Bachelor's degree in Engineering, Science, or another technical field; or equivalent practical experience.
8+ years of experience in the medical device industry, focusing on post-market surveillance or related areas.
Strong knowledge of medical device regulations and quality management systems.
Excellent analytical and problem-solving skills.
Proficiency in data analysis tools, technical writing, and interpersonal skills.
Strong communication and presentation skills.
Ability to work effectively in a cross-functional team environment.

Preferred:

Experience with Class II or III sterile devices.
Experience with electronics devices.

Benefits

Competitive base salary of $150k–$170k.
Stock options – ownership and a stake in a growing mission-driven company.
Employee benefits package that includes 401(k), healthcare insurance, and paid time off.

Calyxo, Inc.

Calyxo, Inc. is an innovation-driven medical device company focused on improving care for patients with kidney stones, a common and painful condition that consumes vast amounts of healthcare resources today. Founded in 2016, Calyxo is led by executives and investors with a strong track record of commercializing paradigm-shifting solutions in the field of urology. Our team features some of the most talented, high-achieving and brightest minds in the medical device industry who are compelled by a desire to make a difference in kidney stone care. We are proud of our collaborative, diverse, fun and dynamic culture.

We drive our actions based on our core values which we call ‘F.I.T to WIN.’

Find Joy: We celebrate wins and enjoy the journey! Integrity: We are truthful, honorable, and reliable. Transparency: We share what’s going on in our business. We are open, honest and have a clear communication across our organization. Win as a Team: We are earnest collaborators. We hold ourselves and each other accountable.

Pleasanton, CA