Position Overview:

The Manager of Technical Operations will lead SoftWave’s operational execution across service operations,

technical engineering support, facilities, and equipment infrastructure. This role is responsible for delivering

operational performance to plan across throughput, cost, and quality objectives, while building the processes,

tools, and systems required to support growth in an early-stage med device environment.

The role will manage approximately 10 direct reports across service, engineering, facilities, and equipment control functions and will serve as a key operational leader supporting scalability and installed base reliability.

This role serves as the operational execution engine for the business, ensuring the company can scale service,

engineering support, and operational infrastructure while maintaining performance to plan.

Responsibilities:

Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions.

Applicator Service Operations

Lead service, repair, refurbishment, and lifecycle management of applicators
Establish turnaround time targets and service workflows
Drive service throughput and quality performance
Coordinate spare parts and refurbishment inventory with Supply ChainDevice Service Operations

Device Service Operations

Lead service operations for the installed base of SoftWave devices
Develop field and depot service processes
Improve service responsiveness, uptime, and service cost efficiency
Support issue escalation and root cause resolution

Engineering Leadership - Provide leadership across technical engineering support functions, including:

Reliability Engineering: Failure analysis, root cause investigation, reliability improvement initiatives
Sustaining Engineering: ECOs, lifecycle support, product changes, field issue resolution
Manufacturing Engineering: Process development, tooling, fixture design, production support, process improvements

Facilities Management

Oversee facilities operations and infrastructure
Ensure site readiness to support production and service activity
Manage safety, workspace planning, utilities, and operational layout improvements

Equipment Control

Lead maintenance and calibration programs
Ensure operational equipment uptime and compliance
Manage preventive maintenance schedules
Maintain calibration records and traceability

Performance Accountability - This role is accountable for performance to plan across:

Throughput
Operational cost
Service turnaround
Quality / reliability
Equipment Uptime

This individual will establish KPIs, dashboards, and management systems to drive accountability and continuous

improvement.

Process &Tools Development - A critical part of the role is to build scalable infrastructure, including:

Standard Operating Processes
Tools and Dashboards
KPI Reporting
Production Planning
Resource Planning models
ERP / Traceability / Servicing Order / CRM

This person will be instrumental in helping SoftWave scale from early-stage operations into a more

structured operating environment.

Team: Approximate direct reports: 10

Functions include:

Service Ops technicians and leads
Reliability engineering / Sustaining engineering / Manufacturing engineering
Facilities / equipment staff

Qualifications:

Required:

Bachelor’s degree in engineering
3 – 5 years of Engineering functional or equivalent technical project / people management experience
1 - 3 years of direct oversight of Manufacturing or Service activities associated with assembly and test processes or equivalent management experience
Strong leadership, people skills, judgment and problem-solving capabilities
Excellent communication, collaboration, and mentoring skills
Experience working in and leading small teams with a great deal of autonomy
Ability to implement, follow and enforce processes and process controls
Strong analytic skills to define, measure and analyze KPIs
Experience working in a regulated environment
Ability to read, understand, and execute job functions in accordance with Standard Operating Procedures

Preferred:

MS / MBA
ERP (NetSuite) experience
Operating in an FDA Refgistered Facility and / or under ISO13485;2016 ; MDSAP QMS Certification
Schedule flexibility to support evening / weekend shifts as Organization needs arise

Physical Requirements:

Sitting, standing and walking, which may be for extended periods of time
Lifting and carrying, up to 100 lbs
Pushing, pulling, and reaching overhead
Manipulation of objects and materials, including holding, grasping, turning, and touching
Driving
Stooping, crouching, kneeling
Climbing ladders or stairs
Hearing, in-person and through the telephone or electronic device (such as a computer)
Speaking, in-person and through the telephone or electronic device (such as a tablet or computer)
Visual acuity, both near (i.e. clarity of vision of approximately 20 inches or less) and far (i.e. clarity of

vision of approximately 20 feet or more)

Regular and predictable attendance

The responsibilities outlined in this job description are intended to describe the general nature and level of work

performed by individuals assigned to this role. They are not intended to be an exhaustive list of all responsibilities,

duties, and skills required. Management reserves the right to amend and change responsibilities to meet

organizational needs as necessary.

SoftWave TRT is an equal opportunity employer. We make employment decisions solely based on business needs,

job requirements, and individual qualifications without regard to race, gender, religion, ethnicity, age, or any other

status protected by the law.

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SoftWave TRT

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