Engineering Machine Shop Manager

The Engineering Machine Shop Manager at SI-BONE is responsible for overseeing all operations within the medical device machine shop. This includes managing machining processes for medical device prototypes, maintaining equipment, ensuring compliance with ISO 13485 standards, and collaborating with engineering staff on innovative solutions. They also handle inventory management and support quality assurance processes, all while fostering a team environment focused on patient care.

Candidates for the Engineering Machine Shop Manager role at SI-BONE should have at least 5 years of experience in medical device machining. A relevant apprenticeship or degree is necessary, alongside familiarity with regulations such as FDA 21 CFR 820 and ISO 14971. Technical skills should include experience with CNC machinery and CAM software, as well as a proven track record of producing quality parts within tight tolerances.

Teamwork is incredibly important for the Engineering Machine Shop Manager at SI-BONE. As you work alongside engineers, quality assurance, and production teams, effective communication and collaboration are key to developing innovative solutions and maintaining high production standards. A successful manager will embody a team player mentality, rolling up their sleeves and working collectively towards common goals.

Compliance is a critical aspect of the Engineering Machine Shop Manager role at SI-BONE. The manager is expected to ensure that all processes align with applicable standards such as ISO 13485 and FDA regulations. This includes the authority to hold products from shipment if non-compliance is detected, and actively reporting any concerns related to quality and safety, thus contributing to the company’s commitment to ethical practices and patient safety.

SI-BONE fosters a culture of agility, creativity, and ethical conduct for its Engineering Machine Shop Manager. The company encourages innovative thinking and a proactive approach to problem-solving, empowering employees to challenge the status quo while working as a cohesive unit. This supportive environment allows for personal and professional growth, making a real difference in the lives of patients.

When answering this question, highlight your hands-on experience with CNC machines, such as mill-turns and 5-axis CNC. Discuss specific projects where you produced close-tolerance parts, demonstrating your technical skills. Emphasize your problem-solving abilities and how you've worked with cross-disciplinary teams to maximize machine efficiency and output.

In your response, discuss your familiarity with standards such as ISO 13485 and FDA regulations. Highlight strategies like regular audits, training sessions for employees, and creating a culture of accountability. Mention your proactive approach to addressing potential compliance issues before they escalate into larger problems.

Illustrate your approach to team motivation by sharing examples from past experiences. Discuss strategies like setting clear expectations, providing regular feedback, and encouraging an inclusive atmosphere where team members feel valued. Highlight how you celebrate successes and foster an environment where creativity and teamwork thrive.

Use this chance to showcase your innovative thinking. Discuss a specific situation where you identified an inefficiency in a machining process, detailed the steps you took to analyze the problem, and the solution you implemented. Quantify the results if possible, such as reduced cycle times or increased quality output.

Talk about your experience with various tools and software used in machining, such as CAM software like Autodesk Fusion 360 or ESPRIT. Explain how these tools enhance productivity and quality control, and describe your comfort level in training others to use these technologies effectively.

Demonstrate your conflict resolution skills by providing a framework for how you approach conflicts. Discuss the importance of open communication and actively listening to differing viewpoints, while working toward a collaborative solution that maintains team cohesion and focus on shared goals.

Detail your experience with managing supplies in the machine shop, including materials, tooling, and consumables. Emphasize practices like maintaining accurate records, forecasting demand, and implementing just-in-time inventory to reduce waste and ensure a smooth production process.

List key qualities such as leadership, technical expertise, attention to detail, and strong communication skills. Relate these qualities to your own experiences and how they have influenced your management style and the success of your teams in previous roles.

Discuss your commitment to safety by outlining safety protocols you’ve implemented in the past, such as regular training sessions and safety audits. Emphasize the importance of fostering a culture where safety is a top priority and encourage team members to voice any safety concerns freely.

Share your insights on how technology, like automation and advanced software, transforms machining processes. Discuss its role in improving efficiency, enabling greater precision, and enhancing quality control, positioning you as someone who stays updated with industry trends and innovations.