Okay, I've searched for Project Manager roles in Santa Clara with a focus on biomedical engineering, requiring 5+ years of experience in medical device R&D, knowledge of risk management, and familiarity with ISO 13485. I have found 47 positions for you.

Sure. Here's the analysis:

Job Analysis:

The Engineering Project Manager at VahatiCor, a portfolio company of T45 Labs, is fundamentally tasked with overseeing the development and manufacturing of Class II and Class III medical devices, specifically catheter products. This role is pivotal as it not only entails meticulous project management concerning timelines and engineering specifications but also involves direct collaboration across multiple teams, including Quality, Regulatory, Clinical, and Manufacturing. Given the high stakes of medical device development, the candidate will confront challenges such as ensuring compliance with stringent FDA regulations and ISO standards, managing risk assessments, and maintaining the integrity of the development process through documentation and testing. Success in this role is marked by the ability to harmonize complex dependencies and deliver products that meet regulatory requirements while adhering to project timelines. The position also emphasizes the importance of hands-on experience and technical expertise, specifically in areas like SolidWorks and risk management methodologies, underscoring that the ability to navigate both engineering challenges and compliance intricacies is essential for effective leadership in this role.

Company Analysis:

T45 Labs is positioned within the competitive MedTech incubator landscape, carving out a niche in the development of minimally invasive technologies for the cardiovascular sector. Their strategy of 'fast-follower' signifies a commitment to innovation while minimizing risk, making agility a hallmark of their operational ethos. Company culture likely prioritizes collaboration, leveraging the diverse expertise of their team members—comprised of seasoned executives and engineers—to drive projects forward effectively. The role of Engineering Project Manager will be situated within this collaborative framework, requiring strong interpersonal skills to coordinate with various departments and ensure seamless communication. Given that T45 Labs functions in a highly regulatory environment, a deep understanding of compliance, risk management, and market dynamics in medical devices is essential. This position strategically aligns with T45 Labs’ broader goals of maintaining high-quality standards while pushing forward new product development, highlighting the importance of this role in shaping the company's future success.

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

• Can you describe a time when you successfully managed a complex engineering project? What challenges did you face, and how did you overcome them?
• Explain your experience with ISO 13485 and how you ensure compliance in the projects you work on.
• Tell me about a situation where you had to manage conflicting priorities from different teams involved in a project. How did you ensure that all parties were satisfied with the outcome?
• Share an experience where you conducted a risk assessment (like FMEA). What was the situation, and what were the results?
• How would you approach managing a project that involves multiple teams, such as Regulatory and Quality? What specific strategies would you use to ensure alignment?
• Describe your experience with SolidWorks. How have you utilized this tool in past projects related to medical device development?
• Imagine you are faced with a tightened timeline due to unexpected regulatory changes. How would you adjust your project management strategy to address this challenge?
• What steps would you take if you discovered a potential hazard during the risk analysis stage of a medical device project?
• Why are you interested in working at T45 Labs and specifically VahatiCor? How do you think you can contribute to our goals?
• How do your previous experiences align with our mission of minimizing risks and maximizing returns in MedTech?
• What do you consider when developing Manufacturing Process Instructions and work instructions for a new medical device?
• What do you hope to achieve within the first six months in this role at VahatiCor?
• What questions do you have about our current projects and how this role fits into them?
• How do you stay updated on new regulations in the medical device industry, and how does that influence your project management practices?