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About the job

Manufacturing Engineering Manager – Medical Devices

Location: Woburn, MA (100% Onsite)

Employment Type: Contract-to-Hire (4-Month Contract, with Hiring Decision at Completion)

Compensation: 75 - 100/hr on contract then $150,000–$220,000 Annually, Depending on Experience

Work Schedule: Full-Time, Onsite

Reports To: Chief Operating Officer (COO)

Overview

KORE1, a nationwide provider of staffing and recruiting solutions, is seeking a Manufacturing Engineering Manager for a growing medical device company developing electrohydraulic shockwave therapy products.

The organization is bringing design and manufacturing operations in-house at its Woburn, MA facility and building its assembly operation from the ground up. This is a unique opportunity to design and establish a medical device production line rather than inherit an existing operation.

The Manufacturing Engineering Manager will own the buildout of the medical device assembly line, including line layout, workstations, fixtures, tooling, work instructions, and process validation. This individual will take a flagship electromechanical medical device from engineering release into stable, scalable production, then oversee and continuously improve day-to-day manufacturing operations.

The ideal candidate is a hands-on manufacturing engineering leader with significant medical device experience who has successfully built or launched an assembly line and understands the requirements of regulated manufacturing environments.

This position works closely with Engineering, Quality, and Supply Chain and will play a key role in hiring, training, and leading the assembly team as operations scale.

Key Responsibilities

Design and build the medical device assembly line from the ground up, including production layout, workstations, material flow, and capacity planning.

Develop fixtures, tooling, and test equipment to support electromechanical medical device assembly.

Create and maintain manufacturing work instructions, routers, standard operating procedures, and assembly documentation.

Lead process validation activities (IQ/OQ/PQ) and support design transfer from Engineering into manufacturing.

Build and lead the assembly technician team, including hiring, training, daily supervision, and performance management.

Drive continuous improvements in manufacturing yield, throughput, efficiency, product quality, and production costs.

Manage production-related Corrective and Preventive Actions (CAPAs) and Nonconformance Reports (NCRs).

Establish production data, manufacturing workflows, and operational processes within the company's NetSuite ERP system.

Partner with Quality to ensure manufacturing operations comply with ISO 13485 and applicable FDA Quality System Regulation / Quality Management System Regulation (QSR/QMSR) requirements.

Collaborate with Engineering, Quality, and Supply Chain to resolve manufacturing challenges, improve processes, and support production scalability.

Required Qualifications

10–15 years of experience in manufacturing engineering or manufacturing operations, including significant experience in the medical device industry.

Demonstrated experience building, launching, or standing up a manufacturing assembly line, ideally for a regulated electromechanical product.

Hands-on experience with process validation (IQ/OQ/PQ) and medical device design transfer.

Strong working knowledge of ISO 13485 and FDA quality system requirements.

Experience leading assembly technicians or a small manufacturing/production team.

Strong understanding of manufacturing process development, tooling, fixtures, assembly operations, and production optimization.

Experience supporting manufacturing quality processes, including CAPAs, NCRs, and continuous improvement initiatives.

Ability to work independently and take ownership of manufacturing processes from initial development through production.

Comfortable working in a fast-paced, entrepreneurial environment where processes, systems, and infrastructure are being developed from the ground up.

Bachelor's degree in Mechanical Engineering, Industrial Engineering, Manufacturing Engineering, or equivalent relevant experience.

Must be located in the Greater Boston area and able to work fully onsite in Woburn, MA.

Preferred Qualifications

Experience with New Product Introduction (NPI), including taking a medical device from pilot production into full-scale manufacturing.

Background in Lean Manufacturing, Six Sigma, or related continuous improvement methodologies.

Experience implementing or configuring manufacturing workflows within an ERP system; NetSuite experience is a plus.

Experience manufacturing capital equipment, electromechanical devices, or energy-based therapy products.

Previous experience scaling a manufacturing team, production line, or facility during a period of rapid growth.

Experience working in an early-stage or rapidly expanding medical device organization.

Work Environment & Contract Details

Location: Fully onsite at the Woburn, Massachusetts manufacturing facility.

Candidate Location: Must be local to the Greater Boston area.

Employment Type: Full-time, contract-to-hire.

Initial Contract Duration: 4 months, with a permanent hiring decision at the end of the contract period.

Compensation: $150,000–$220,000 annualized, depending on experience and qualifications.

Reporting Structure: Reports directly to the COO.

This position offers the opportunity to establish and lead