Medical Device Manufacturing Engineer (Capital Equipment)

ipgjobs; Marlborough (MA); On-site; USD 90,000 - 120,000; Full time

Job summary

IPG Photonics in Marlborough, MA is seeking a Manufacturing Engineer to support the manufacture and service of medical devices and disposables. The role focuses on production workflow optimization, documentation, tooling development, regulatory compliance, and cross-functional collaboration to ensure efficient, compliant operations.

This position operates under IPG Medical Corporation Quality Management System and applicable standards, with responsibilities spanning work instructions, tooling,

Qualifications

• Bachelor's degree in a technical field or equivalent experience.
• Strong knowledge of U.S. and global regulatory requirements for medical devices.
• Solid project management skills.
• Russian language knowledge preferred but not required.

Responsibilities

• Organizes production workflow to maximize efficiency and contain total costs of assembly.
• Develops, approves, and reviews work instructions and test procedures to support standardized work in the production area.
• Develops and qualifies tooling to improve manufacturing process yield and reduce process variation.
• Conducts training for production and quality associates.
• Assists with planning, scheduling, and coordination of production activities to fulfill customer orders.
• Executes production process transactions using the ERP system.
• Ensures compliance of the production environment with cGMP, ISO, and all other applicable medical device standards and regulations.
• Initiates and executes disposition of Non‑Conforming Material Reports (NCMRs); assists with investigation of production‑related CAPAs.
• Works with engineering to feedback design issues and resolve them for future builds through the ECO system.
• Participates in new vendor qualification activities to improve supplier performance.
• Evaluates alternate sources for BOM components and makes recommendations to design engineering.
• Initiates process control improvements to support cost reduction and on‑time delivery objectives.
• Participates in service and repair of customer‑owned and remanufactured equipment.
• Develops and executes experiments to test new components and manufacturing processes prior to product use.

Skills

Regulatory knowledge

Project management

Communication skills

Education

Bachelor of Science in a technical discipline

Tools

ERP systems

Test equipment (DMMs, oscilloscopes)

Job description

IPG Photonics is revolutionizing the laser industry as the pioneering developer and leading producer of fiber lasers and amplifiers. Headquartered in Marlborough, MA, IPG has over 4,800 employees in more than 30 locations around the world. We aspire to work together with our employees and customers to apply light in ways that improve life.

Our mission is to develop innovative laser solutions to make the world a better place. To accomplish this mission, we are committed to attracting and retaining the best talent and an engaged and thriving workforce that drives a sustainable future for our company and society.

Working at IPG Photonics you can expect challenging projects, a motivating and friendly environment, and competitive benefits.

Job Summary

The Manufacturing Engineer is responsible for supporting the manufacture and service of medical devices and disposables. This role focuses on production workflow optimization, documentation, tooling development, regulatory compliance, and cross-functional collaboration to ensure efficient, compliant, and repeatable manufacturing operations.

This position is governed by the IPG Medical Corporation Quality Management System and applicable regulatory and quality standards.

Job Functions

• Organizes production workflow to maximize efficiency and contain total costs of assembly.
• Develops, approves, and reviews work instructions and test procedures to support standardized work in the production area.
• Develops and qualifies tooling to improve manufacturing process yield and reduce process variation.
• Conducts training for production and quality associates.
• Assists with planning, scheduling, and coordination of production activities to fulfill customer orders.
• Executes production process transactions using the ERP system.
• Ensures compliance of the production environment with cGMP, ISO, and all other applicable medical device standards and regulations.
• Initiates and executes disposition of Non‑Conforming Material Reports (NCMRs); assists with investigation of production‑related CAPAs.
• Works with engineering to feedback design issues and resolve them for future builds through the ECO system.
• Participates in new vendor qualification activities to improve supplier performance.
• Evaluates alternate sources for BOM components and makes recommendations to design engineering.
• Initiates process control improvements to support cost reduction and on‑time delivery objectives.
• Participates in service and repair of customer‑owned and remanufactured equipment.
• Develops and executes experiments to test new components and manufacturing processes prior to product use.

Requirements

Education

• Bachelor of Science degree in a technical discipline or equivalent work experience.
• Strong knowledge of U.S. and global regulatory requirements for medical devices.
• Solid project management skills.
• Knowledge of the Russian language is preferred but not required.

Experience

• 3-5+ years of experience in the manufacture and service of medical device equipment
• Disposable medical device a plus
• Laser experience a plus
• Proficient in the use of test equipment such as digital voltmeters, oscilloscopes, and laboratory power supplies.
• Proficient with light manufacturing and assembly equipment, including PCB soldering stations and wire cutting/stripping tools.
• Working knowledge of ERP systems and Microsoft Office applications.

IND123

#ZR