Manager, Technical Operations

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.