Field Service Engineering Supervisor

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Field Service Engineering Supervisor

@ Tides Medical

Purpose of Position:

• Under the leadership of the Senior Manager of Customer Operations, the Field Service Engineering Supervisor oversees the development and optimization of the field service function, including supporting a first-of-its-kind intraoperative 3D printer for wound care.
• This role provides technical expertise, leads a team of technicians, and collaborates cross-functionally to drive innovation, improve product quality, and enhance operational efficiency.

Essential Functions of the Areas of Responsibility:

• Lead the field service department and supervise a team of technicians 
• Develop, implement, and optimize processes to enhance efficiency, quality, and compliance with FDA, ISO, and other regulatory standards.
• Conduct root cause analysis and implement corrective and preventive actions (CAPA) for process deviations and non-conformances.
• Collaborate cross-functionally with Customer Service, Quality, and other departments to support new product introductions and process validation.
• Develop and maintain process documentation, including SOPs, work instructions, validation protocols, and reports.
• Lead process validation activities (IQ, OQ, PQ) and ensure compliance with industry standards.
• Identify and implement cost-saving and continuous improvement initiatives using Lean and Six Sigma methodologies.
• Manage technical projects, facilitate meetings, and serve as a Point-of-Contact (POC) on multiple projects as the technical lead.
• Provide data analysis, including statistical analysis, to support decision-making.
• Ensure proper maintenance, calibration, and validation of equipment and tools.
• Frequently communicate status updates to leadership and stakeholders.
• Ensure projects meet design, development, technology transfer, validation, and post-launch requirements.
• Apply engineering principles and scientific expertise to develop solutions for complex problems.

Expectations:

• Work well with others and not create undue office stress or conflicts.
• Be a practical problem solver and work independently.
• Be truthful in all aspects of conduct and communications.
• Be respectful of other employees and not engage in speech or conduct that is discriminatory.
• Uphold confidentiality of employee records, donor records, and proprietary corporate information

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Qualifications:

Requirements:

Key Qualifications, Requirements, and Attributes:

• Bachelor’s degree in Engineering (Mechanical, Biomedical, Industrial, or related field).
• 8+ years of experience in medical device processes or process engineering
• Experience with 3D printing preferred
• Strong knowledge of medical device regulations (FDA 21 CFR Part 820, ISO 13485, ISO 14971).
• Experience with process validation (IQ/OQ/PQ)
• 1-2 years experience in a supervisory or leadership role 
• Strong communication and collaboration abilities.
• Experience using CRM or internet-based inventory tracking systems is preferred

Physical, Mental, Environmental Demands:

• Up to 8 hours of sitting, walking, using a computer, etc.
• Must be able to lift up to 25 pounds
• Must be able to hear and speak on the phone
• Must be able to perform job duties in a fast-paced work environment
• US travel required, up to 40%
• This is a hybrid position with a preferred location in the Boston, Massachusetts or Lafayette, Louisiana areas. 

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How to Apply:

Apply online at https://www.tidesmedical.com/careers/. 

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