Senior Principal Test Engineer

Senior Principal Test Engineer

At Mini Med, you can begin a lifelong career of exploration and innovation, while helping make a difference in the lives of people living with diabetes around the globe. You'll lead with purpose, breaking down barriers to innovation for a more connected, compassionate world.

We are seeking a highly skilled and experienced Senior Principal Test Engineer to join our team in the medical device industry. In this role, you will lead the design, development, and deployment of complex test equipment to ensure the highest quality and reliability of our innovative medical devices. You will collaborate with cross-functional teams, including R&D, manufacturing, and quality assurance, to deliver robust testing solutions that meet regulatory and industry standards.

This role requires a strong technical background, leadership skills, and a passion for advancing healthcare technologies.

Why Join Us?

- Be part of a team that develops life-saving medical devices and technologies.

- Work on cutting-edge projects that push the boundaries of healthcare innovation.

- Enjoy a collaborative and supportive work environment with opportunities for professional growth.

This role is ideal for a dynamic and innovative engineer who thrives in a fast-paced, high-impact environment. If you are passionate about developing advanced test systems and making a difference in the medical device industry, we encourage you to apply!

Responsibilities may include the following and other duties may be assigned.

Test Equipment Design & Development

• Lead the design and development of complex automated and manual test equipment for medical devices, ensuring compliance with industry standards and internal requirements.
• Define system architecture, hardware, and software requirements for test equipment.
• Develop test methods, protocols, and procedures to validate product functionality, performance, and reliability.

Project Management:

• Manage multiple test equipment development projects from concept to deployment, including timelines, budgets, and resource allocation.
• Collaborate with cross-functional teams to align testing strategies with product development goals and manufacturing processes.

Validation and Verification:

• Oversee the validation and verification of test equipment, including IQ, OQ, and PQ activities, in compliance with FDA, ISO, and other regulatory standards.
• Ensure all test equipment meets safety and quality requirements before deployment.

Deployment and Support:

• Lead the deployment of test equipment to manufacturing facilities and provide training to operators and technicians.
• Troubleshoot and resolve technical issues with test equipment in a timely manner.

Continuous Improvement:

• Identify opportunities for process improvements, cost reductions, and increased efficiency in test equipment design and deployment.
• Stay up-to-date with emerging technologies and industry trends to drive innovation in test methodologies.

Documentation and Compliance:

• Develop and maintain detailed documentation, including design specifications, test plans, and validation reports.
• Ensure compliance with all applicable regulatory standards, such as FDA, ISO 13485, and IEC 60601.

Mentorship and Leadership:

• Mentor and guide junior engineers and technicians, fostering a culture of technical excellence and continuous learning.
• Act as a technical expert and provide guidance on complex engineering challenges

Minimum Qualifications:

Requires a bachelor's degree and minimum of 10 years of relevant experience OR Master's degree with a minimum of 8 years relevant experience OR PhD with 6 years relevant experience.

Preferred Qualifications:

• Proficiency in hardware and software development for test systems (LabVIEW, Python, C++, or similar).
• Proficiency in PCBA Design and Fabrication (Altium Designer)
• Strong knowledge of data acquisition systems, sensors, actuators, and control systems.
• Experience with automated test equipment (ATE) and robotics is a plus.
• Regulatory Knowledge:
• Familiarity with FDA, ISO 13485, IEC 60601, and other relevant medical device standards.
• Experience with risk management and Design for Testability (DFT) principles.
• Soft Skills:
• Strong problem-solving, analytical, and critical-thinking skills.
• Excellent communication and interpersonal skills to work effectively with cross-functional teams.

Mini Med offers a competitive salary and flexible benefits package

At Mini Med, we put people first. A commitment to our employees lives at the core of our values:
We recognize their contributions. They share in the success they help create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every stage of your career and life.

Salary ranges for U.S (excl. PR) locations (USD):$ - $

For roles located in California, Seattle WA, Washington DC, Boston MA, and New York City, the salary range is $  - $  USD.

Actual compensation may vary based on factors including experience, education,…