Managing Principal Engineer, Instruments and Accessories

As a Managing Principal Engineer at Noah Medical, you'll be responsible for leading a small technical team that develops complex medical instruments and accessories for robotic surgery. This involves creating problem statements, guiding product design, maintaining project schedules, and ensuring collaboration with cross-functional teams including Clinical, Marketing, and Engineering. Additionally, you'll lead design reviews, manage documentation for products, and oversee the manufacturing transfer of the finished designs.

To qualify for the Managing Principal Engineer role at Noah Medical, candidates should have 12 to 15 years of experience in designing and developing complex medical devices, particularly those involving robotic applications. A B.S. degree in Mechanical, Bio-medical, or a related discipline is required, while an M.S. or Ph.D. is preferred. Familiarity with regulatory standards and advanced SolidWorks skills are also essential for success in this role.

Candidates applying for the Managing Principal Engineer position at Noah Medical should possess extensive experience in medical device product development, particularly with robotic instruments and accessories. Experience with sterilization processes, risk analysis, and cross-functional teamwork is crucial as well. Previous involvement in commercially launching new products and knowledge of FDA submission processes will also be advantageous.

The Managing Principal Engineer position at Noah Medical is based onsite in San Carlos, California, where you'll thrive in a supportive and dynamic startup environment. With a focus on innovation and collaboration, you'll be part of a talented team working towards a common goal: transforming medical robotics. The company offers competitive benefits and a culture that encourages professional growth and teamwork.

Noah Medical is committed to fostering employee development for all roles, including the Managing Principal Engineer. The company provides learning and development opportunities such as on-demand online training and book reimbursement. Employees are encouraged to continuously improve their skills and knowledge, with additional support through mentorship and team-building activities.

When answering this question, highlight specific projects you've worked on that involved robotic medical devices. Discuss your role in the project, the challenges you faced, and the outcomes. Emphasize your familiarity with the entire product development cycle, from conception to manufacturing.

Share your leadership philosophy, including how you motivate your team and encourage collaboration. Discuss specific examples where you provided guidance and mentorship to less experienced engineers and the impact it had on project outcomes.

Discuss your knowledge of relevant regulatory standards such as IEC 60601-1 and your experience with the FDA submission process. Share specific examples where you ensured compliance during design and development, highlighting your understanding of the importance of these standards in product safety and efficacy.

Explain how you assess project priorities based on deadlines, stakeholder requirements, and resource availability. Provide examples where you successfully managed multiple projects simultaneously and the decision-making processes you used to make trade-offs.

Discuss your conflict resolution approach, emphasizing open communication and collaboration. Provide an example where you managed a disagreement within a team and how you worked towards a constructive resolution that benefited the project's progress.

Share your experience with dFMEA and other risk assessment tools. Describe how you identify potential risks in product development and the mitigation strategies you've implemented to reduce their impact on project timelines and outcomes.

Describe your approach to collaborating with NPI and manufacturing teams. Emphasize the importance of detailed documentation and open lines of communication during the product handover process. Share a specific success story where your efforts led to a seamless transition.

Discuss the significance of innovation in developing effective medical devices. Provide examples of how you've incorporated innovative solutions into past projects and the benefits that resulted for patients and healthcare providers.

Share a specific process improvement you initiated or contributed to during product development. Discuss the problem, what steps you took to improve it, and the positive outcomes resulting from your efforts, such as reduced costs or improved efficiency.

Emphasize your communication strategies, such as regular meetings, shared documentation, and active listening. Provide examples of how you facilitated productive discussions across various teams to ensure everyone remained aligned on project goals.