Principal Manufacturing Engineer

Exergen Corporation; Watertown (MA); On-site; USD 120,000 - 150,000; Full time

Job summary

Exergen Corporation in Watertown, MA seeks a Principal Manufacturing Engineer to lead manufacturing engineering activities for new and existing products, focusing on readiness, quality, throughput, yield, and cost.

The role requires a strong electrical/electronics background, PCB design, experience with ISO 13485 and FDA regs, and hands-on ability to mentor staff while driving continuous improvement in automation and test systems.

Qualifications

• BS degree required in Electrical/Electronics or related field.
• 10+ years in manufacturing engineering roles with FDA/ISO exposure.
• Experience with PCB design, schematics, and electrical assemblies.

Responsibilities

• Lead manufacturing engineering activities for new and existing products, focusing on readiness, quality, reliability, throughput, yield, and cost.
• Provide hands-on technical support to production for troubleshooting electrical/electronic assemblies, manufacturing equipment, and test systems.
• Lead root cause analysis of production failures and implement corrective actions.
• Develop and improve manufacturing processes, methods, fixtures, tooling, and test systems to improve quality and efficiency.
• Support NPI activities from prototype through production transfer and ongoing support.

Skills

Electrical engineering

PCB design

Root cause analysis

Process improvement

ISO 13485 experience

Manufacturing automation

Team leadership

Supplier cost-reduction

LabVIEW knowledge

Education

BS in Electrical Engineering or related field

Tools

LabVIEW

Job description

Exergen Corporation is the recognized world leader in medical non-invasive temperature technology. Exergen invented and manufactures non-invasive temperature measurement devices providing lower cost, higher accuracy, less invasiveness, and greater reliability than ever previously possible.

Our Temporal Scanner™ is the most efficacious, non-invasive thermometer ever created. Exergen holds over 100 issued and pending U.S. and foreign patents, and is the only manufacturer of retail medical thermometers in the U.S. Presently, half of hospitals and pediatricians currently use the Exergen Temporal Scanner, and well over 12 million consumers use one at home.

Founded by Harvard-research scientist, Dr. Francesco Pompei, over three decades ago, Exergen Corporation is based in Watertown, Massachusetts, USA.

Principal Manufacturing Engineer

Qualifications

• BS degree in Electrical Engineering, Electronics Engineering, or a related engineering or science field.
• 10+ years of progressive technical experience in manufacturing engineering, production engineering, electrical/electronic product development, or a combination of these disciplines.
• Demonstrated experience supporting manufacturing operations, troubleshooting production issues, improving manufacturing processes, and transitioning new products into production.
• Strong electrical/electronics engineering background, with demonstrated experience in PCB design, electrical schematics, circuit analysis, electronic component selection, and electronic assemblies.
• Medical device design, manufacturing, and production support experience, preferably in an ISO 13485-regulated environment.
• Experience with consumer electronics design and high-volume production is highly desirable.
• Strong experience with root cause analysis and structured problem-solving techniques for electrical/electronic failures, manufacturing issues, and process problems.
• Experience with manufacturing automation, automated test systems, production test equipment, fixtures, and process automation.
• Experience developing and improving manufacturing processes with an emphasis on product quality, reliability, throughput, yield, and cost.
• Working knowledge of IEC 60601 standards and their application to medical electrical equipment.
• Experience with FDA-regulated medical device development, manufacturing, and quality systems is highly desirable.
• Experience working within an ISO 13485 Quality Management System is highly desirable.
• Experience with electronic component lifecycle management, including component availability, obsolescence, alternate component evaluation, and risk mitigation.
• Experience with LabVIEW is a plus.
• Ability to work independently, lead complex technical investigations and manufacturing improvement initiatives, provide technical direction, and mentor engineers and technical personnel.

Duties and Responsibilities

• Lead manufacturing engineering activities for new and existing products, with an emphasis on manufacturing readiness, product quality, reliability, throughput, yield, cost, and continuous improvement.
• Provide hands‑on technical support to production for troubleshooting electrical and electronic assemblies, manufacturing equipment, production test systems, fixtures, and processes.
• Lead root cause analysis of production failures, failed PCBs, electrical/electronic components, manufacturing processes, and other product-related issues, and develop effective corrective and preventive actions.
• Develop, improve, and implement manufacturing processes, methods, fixtures, tooling, and production test systems to improve product quality, efficiency, reliability, and cost.
• Identify opportunities for manufacturing automation and develop or support automated equipment, test systems, fixtures, and processes to improve product quality, throughput, yield, and efficiency.
• Create, modify, and maintain electrical/electronic designs, including Printed Circuit Boards (PCBs), electrical circuits, wiring, and electronic assemblies, as required to support manufacturing, product improvements, troubleshooting, and cost reduction.
• Perform hands‑on PCB troubleshooting, soldering, component replacement, and rework as required to support engineering investigations and production.
• Conduct bench testing, circuit analysis, troubleshooting, and design evaluations to characterize and resolve electrical and electronic issues.
• Work closely with the software/firmware team to test, debug, and integrate firmware and electronic hardware for new and updated products.
• Develop and improve production test methods and equipment to ensure products meet defined performance, quality, and reliability requirements.
• Support new product introduction (NPI) activities from prototype development through manufacturing transfer, verification, validation, production release, and ongoing production support.
• Create and maintain Bills of Material (BOMs), Quality Control Inspection (QCIs), manufacturing procedures, test procedures, product specifications, engineering drawings, work instructions, and other required product and manufacturing documentation.
• Initiate and process Engineering Change Orders (ECOs) and Temporary Change Orders (TCOs) in accordance with established procedures.
• Perform verification and validation activities for new and updated manufacturing processes, equipment, and product designs, and document results in Technical Documents (TDs) and other required engineering documentation.
• Lead or participate in corrective and preventive actions (CAPA), nonconformance investigations, and other quality-related activities involving manufacturing processes, electrical/electronic assemblies, and products.
• Support investigations of customer complaints, product failures, and field issues involving electrical/electronic systems and manufacturing processes.
• Work with Purchasing and suppliers to identify and qualify suppliers capable of manufacturing new designs and supporting existing production requirements.
• Work with suppliers to identify opportunities for cost reduction, quality improvement, process improvement, manufacturing efficiency, and supply‑chain risk reduction.
• Support electronic component lifecycle management, including identification and qualification of alternate components and mitigation of component obsolescence.
• Drive continuous improvement initiatives related to manufacturing processes, product reliability, production yield, test methods, automation, quality, and cost reduction.
• Provide technical leadership and mentoring to manufacturing engineers, electrical engineers, technicians, and other engineering and production personnel.
• Ensure manufacturing processes and electrical/electronic product designs comply with applicable regulatory, safety, and quality requirements, including IEC 60601 standards.
• Support compliance with FDA requirements and the company's ISO 13485 Quality Management System.
• Adhere to established procedures under the Exergen Quality System and maintain appropriate engineering, manufacturing, and quality documentation.