Senior/Principal Manufacturing Engineer

As a Senior/Principal Manufacturing Engineer at MicroTransponder, your primary responsibilities include overseeing manufacturing development for both existing products and upcoming innovations. You will create and manage master validation plans, collaborate with contract manufacturers, and ensure strict adherence to quality and regulatory standards. Your role also involves providing technical expertise in process validation and development, managing manufacturing procedures, conducting risk assessments, and improving processes using methodologies like Six Sigma.

To qualify for the Senior/Principal Manufacturing Engineer position at MicroTransponder, candidates must hold a Bachelor’s Degree in a relevant field and possess over 5 years of experience in the medical device industry. You should also have experience in medical device manufacturing and vendor management. Familiarity with tools like Minitab, Solidworks, and project management software is essential, along with strong problem-solving skills and a continuous improvement mindset.

The Senior/Principal Manufacturing Engineer at MicroTransponder plays a crucial role in developing and refining medical devices that directly impact patient outcomes. By ensuring that products are manufactured to the highest standards through effective process and validation management, you contribute significantly to the availability and reliability of innovations like the Vivistim® System, which aids in improving hand and arm functions for stroke survivors.

At MicroTransponder, a Senior/Principal Manufacturing Engineer will engage in a variety of projects, including product manufacturing and process validation for new and existing devices. You'll participate in product development projects, manage manufacturing-related activities, and oversee the implementation of statistical process control techniques that enhance production efficiency and product quality.

Important personal qualities for a Senior/Principal Manufacturing Engineer at MicroTransponder include strong analytical skills, a collaborative spirit, and excellent communication abilities. You should be detail-oriented and possess a proactive approach to problem-solving. Given the crucial nature of this role, an ability to work independently while being an effective team player is essential in driving projects and fostering a culture of continuous improvement.

When answering this question, highlight specific examples of projects where you ensured compliance with FDA regulations. Discuss your familiarity with the necessary documentation and validation processes that align with these regulations, showcasing your thorough understanding of quality assurance in medical device manufacturing.

To effectively answer this question, describe your methodical approach to process validation, including how you've implemented techniques such as IQ, OQ, and PQ. Additionally, discuss any tools or methodologies, like Lean or Six Sigma, that you’ve utilized to identify areas for process improvement.

In your response, share specific experiences where you've overseen or collaborated with contract manufacturers on projects. Highlight any challenges you faced and how you successfully navigated them to ensure product quality and continuity.

When addressing this topic, focus on your communication strategies and collaborative practices you’ve employed. Discuss examples of how you facilitated cross-functional teamwork to achieve project goals, emphasizing your role in bridging gaps between different departments.

Explain your experience with statistical software like Minitab, detailing how you’ve leveraged data analysis to identify trends, improve processes, or enhance product quality. Illustrate your ability to distill complex data into actionable insights.

Provide a detailed account of a specific incident where you identified and resolved a manufacturing challenge. Highlight your problem-solving process, the steps you took, and the positive outcome of your intervention.

Share your experience in managing multiple projects simultaneously, using prioritization techniques such as the Eisenhower Matrix or Agile methodologies. Discuss how you ensure deadlines are met without sacrificing quality.

Discuss your approach to continuous improvement, citing methodologies you’ve applied, such as DMAIC or Kaizen. Provide examples of successful initiatives you've led or participated in that resulted in measurable improvements.

Reflect on a specific challenge within the medical device sector and the steps you took to address it. Focus on the strategies employed, the collaboration with team members, and any insights gained from overcoming the obstacle.

In your answer, explain the importance of risk assessment in the manufacturing process. Share experiences with conducting FMEAs and how you've applied those assessments to mitigate risks and ensure product reliability.