Medical Device Service Engineer

Mallinckrodt Pharmaceuticals•Madison, WI

1d•Hybrid

About The Position

The Medical Device Service Engineer role blends hands-on technical work with clear, accurate documentation, technical writing and requires strong communication skills to support customers, internal teams, and regulatory needs. The ideal candidate is detail oriented, comfortable working in clinical or laboratory environments, and experienced with GxP aligned processes. This role provides guidance and support of service methods/processes, tooling, equipment, test systems, troubleshooting and repairing medical devices in compliance with regulatory, quality and good documentation standards to ensure effective and timely medical device servicing activities. Ensures compliance with the company quality system, in accordance with the applicable Code of Federal Regulations, ISO 13485, customer and company requirements. Completes all assigned project work in a timely manner balancing customer and business requirements with technical and operational capabilities. Responsible for training and support of other Service personnel that perform scheduled maintenance and repair activities on INOmax devices. Provides Subject Matter Expert (SME) level technical expertise and support to ensure service procedures and manuals are current and compliant. This position will also play an important role in promoting teamwork between Regional Service Centers (RSC) service activities and manufacturing, to foresee problems with product assembly or service practices.

Requirements

Bachelor of Science in Engineering (BSE) preferred; minimum of a two‑year technical degree in electronics, biomedical engineering, mechanical engineering, or related discipline is required or military equivalent training with 5+ years electromechanical maintenance experience required.
Minimum of 1–3 years of related experience servicing medical devices, laboratory instrumentation, or comparable electromechanical systems.
Demonstrated experience in technical writing, including preparation of service documentation, SOPs, or technical reports.
Familiarity with GxP processes (GMP, GLP, GCP) and experience working in regulated environments (preferred).
Strong analytical, diagnostic, and problem‑solving skills.
Proficiency in reading schematics, using diagnostic tools, and working with software‑driven devices.
Effective written and verbal communication skills with the ability to interact professionally with customers and internal teams.
Ability to travel as required to support service operations

Nice To Haves

Experience with FDA‑regulated medical devices or ISO 13485 environments.
Knowledge of networking, device connectivity, or software‑driven instrumentation.
Certification in biomedical equipment technology (CBET) or similar credentials
Microsoft Office
SAP Service module (SM) preferred
Proficient in the existing Keenova service model for the INOmax platform
Conducting training classes
Detail oriented
Excellent written and oral communication skills
Able to analyze, prioritize and manage multiple tasks
Technical analysis and evaluation
Ability to perform root cause analysis and drives problems to resolution
Organizational

Responsibilities

Mastery of all Service Technician requirements including Evolve Service Log analysis
Develop in the role to train new Service Technicians – all levels
Ability to create or update service procedures and service manuals as part of the change control process
Supports the requirements of medical device design controls process from a Service aspect
Supports new device launches regarding Service requirements
Defines and updates as required the ERP process for recording Service documentation
Utilize existing utility, workflow and business demand metric reports to manage the service workflow
Trained as a technical expert on the existing service process and requirements
Manage and/or participate in related project work as assigned
Ensure compliance with Quality, Safety and Regulatory initiatives.
Perform installation, calibration, preventive maintenance, and repair of medical devices and related systems.
Diagnose technical issues using electronic, mechanical, and software‑based troubleshooting methods.
Document service activities with clear, concise, and compliant manner.
Ensure all work adheres to GxP, ISO, and company quality system requirements.
Collaborate with engineering, quality, and product teams to escalate issues and support continuous improvement.
Follow all safety protocols and maintain a professional presence in clinical and laboratory settings.
Develop and revise service documentation (Standard Operating Procedures (SOP), Work Instructions (WI), Service Bulletins (SB), Process Flow Diagrams or other quality documentation, as necessary, to support service processes.
Support all service methods, tooling, preventive maintenance, equipment calibration, test systems, and documentation ensuring compliance with company quality system and regulatory requirements.
Work closely with Manufacturing Engineering, Sustaining Engineering, and GDE to improve service processes and design for service ability in a timely manner.
Train Service Associates on new and/or revised service processes, equipment, and documentation.
Proficient in standard office software (ie MS Word, Excel, etc.).
Ability to work scheduled/expanded shifts, holidays and/or off-shift duties, as necessary.
May perform other duties as required to meet business needs.