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Validation Engineer Biomedical Jobs in Warren, MI

Must have reliable transportation and a valid driver's license. * Legal authorization to work in ... biomedical or electronic equipment. * Analytical and communication skills with the ability to ...

Must have reliable transportation and a valid driver's license. * Legal authorization to work in ... biomedical or electronic equipment. * Analytical and communication skills with the ability to ...

Provide technical subject matter expertise for new system validation and change management efforts ... We look for Science - Biotechnology, Pharmaceutical Technology, Biomedical Engineering ...

Provide technical subject matter expertise for new system validation and change management efforts ... We look for Science - Biotechnology, Pharmaceutical Technology, Biomedical Engineering ...

Provide technical subject matter expertise for new system validation and change management efforts ... We look for Science - Biotechnology, Pharmaceutical Technology, Biomedical Engineering ...

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Validation Engineer Biomedical information

See Warren, MI salary details

$21

$48

$73

How much do validation engineer biomedical jobs pay per hour?

As of Aug 18, 2026, the average hourly pay for validation engineer biomedical in Warren, MI is $48.84, according to ZipRecruiter salary data. Most workers in this role earn between $37.02 and $59.38 per hour, depending on experience, location, and employer.

What does a validation engineer do in biomedical?

A Validation Engineer in the biomedical industry ensures that equipment, processes, and systems used in the production of medical devices or pharmaceuticals meet regulatory standards and function as intended. Their work involves planning and executing validation protocols, documenting results, and troubleshooting any deviations. This role is crucial for maintaining product quality, patient safety, and compliance with regulatory agencies such as the FDA. Validation Engineers often collaborate with quality assurance, manufacturing, and research teams to establish and maintain validated systems throughout a product's lifecycle.

What are the key skills and qualifications needed to thrive as a validation engineer in biomedical?

To thrive as a Validation Engineer in Biomedical, you need a solid background in engineering or life sciences, knowledge of regulatory standards (such as FDA or ISO 13485), and experience with validation protocols. Familiarity with technical tools like statistical analysis software, calibration equipment, and documentation systems is essential, and certifications such as Six Sigma or CQE can be advantageous. Strong problem-solving, attention to detail, and effective communication skills help you excel in cross-functional teams and ensure compliance. These skills are crucial for maintaining product quality, meeting regulatory requirements, and ensuring patient safety in biomedical environments.

What are some typical challenges faced by validation engineers in the biomedical industry and how can they be addressed?

Validation Engineers in the biomedical field often face challenges such as keeping up with evolving regulatory requirements, managing complex documentation, and ensuring equipment or processes meet stringent quality standards. Navigating audits and working cross-functionally with R&D, manufacturing, and quality assurance teams can also be demanding. To address these challenges, staying current with industry regulations, developing strong organizational and communication skills, and maintaining meticulous records are essential for success and career growth in this role.

What is the difference between Validation Engineer Biomedical vs Quality Assurance Engineer Biomedical?

AspectValidation Engineer BiomedicalQuality Assurance Engineer Biomedical
CertificationsGMP, ISO, FDA validation certificationsGMP, ISO, audit and compliance certifications
Work EnvironmentDesign, develop, and execute validation protocols for medical devicesDevelop and maintain quality systems, audits, and process improvements
Industry UsagePrimarily in medical device manufacturing and regulatory validationAcross medical device, pharmaceutical, and biotech industries

Validation Engineer Biomedical focuses on ensuring medical devices meet regulatory validation requirements through testing and protocols. Quality Assurance Engineer Biomedical emphasizes maintaining quality systems, compliance, and process improvements. Both roles are essential in the biomedical industry but serve different functions related to validation versus quality assurance.

What are popular job titles related to Validation Engineer Biomedical jobs in Warren, MI?

For Validation Engineer Biomedical jobs in Warren, MI, the most frequently searched job titles are:

What job categories do people searching Validation Engineer Biomedical jobs in Warren, MI look for?

The top searched job categories for Validation Engineer Biomedical jobs in Warren, MI are:

$80K - $100K/yr

Full-time

Re-posted 23 days ago


Job description

Job Description Summary
The Field Service Engineer (FSE) provides frontline support by resolving customers' concerns and issues through technical expertise and troubleshooting. The FSE inspects, troubleshoots, repairs, calibrates, and verifies the performance of complex and intricate imaging equipment while providing regular communications to Avante Health Solutions team members and customers. This position responds to and resolves all service-related issues primarily within an assigned territory, Detroit, Michigan, and requires timely travel response to the customers site location. The FSE position is a remote position that does not require daily or regular attendance at an Avante Company office. This is a work from home dispatched position.
The identification of Essential Job Functions does not display an exhaustive list of all duties that may be assigned to this position, nor does it restrict the related work that may be assigned to this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Essential Job Functions amp; Responsibilities
  • Serves as primary onsite support engineer for all customers within assigned territory for contract, warranty, and billable service calls; provides back-up onsite support in other territories as necessary
  • Communicates with internal Service Support team to receive and provide detailed follow-up information regarding new service calls, follows-up on open calls, and brings issues to closure
  • Ensures company values are upheld in all customer communications, and the highest level of customer service is provided in all interactions; represents Avante in a professional and positive manner
  • Uses critical thinking to resolve issues within defined procedures and practices to identify appropriate action to repair equipment rapidly and accurately
  • Consults by phone, Teams, and e-mail with Director of Service, Service Manager, and technical staff to communicate information regarding system troubleshooting, diagnosing the problem, and determining best practice to resolve issue; effectively communicates system status and time of escalation per Avante Escalation Procedure
  • Travels to customer sites to diagnose and repair system failures, provides routine Preventive Maintenance (PM) services, and other duties as required by contract or leadership direction
  • Resolves system and component issues by reloading software and replacing hardware to resolve equipment issues and maximize equipment performance to OEM (Original Equipment Manufacturers) specifications
  • Generates system sales leads and communicates those leads back to sales team
  • Trains and disseminates knowledge to the rest of the organization regarding equipment
  • Participates in the on-call rotation schedule for after-hours technical support calls
  • Complies with policies, guidelines, and regulatory requirements per ISO 13485:2016 standards and the Company's Quality Management System
  • Demonstrates success and a passion for servicing and learning new technologies which generally includes training opportunities in Avante supported modalities and system models
  • Identifies improvement opportunities to processes and offers applications and solutions to promote optimal efficiency
  • Works professionally, respectfully, and efficiently with all levels within the organization
  • Adheres to all company employment policies and safe practices
  • Performs other duties as assigned
Experience/Training/Education
  • Associate’s degree in biomedical, electrical/electronics, or computer engineering technology; military training; or equivalent combination of education and experience
  • 2 to 4 years of Ultrasound and/or medical diagnostic imaging troubleshooting and repair experience required
  • Advance troubleshooting knowledge of any combination of multi-OEM, multi-modality field service experience a plus
Special Requirements
  • A cover letter and resume are required to apply for this position.
  • To service customer contracts, employees could be required to go through different credentialing processes. This is a requirement of this job.
  • Travel to customer sites will include 50-75 percent of work; must be willing and able to travel by all modes of transportation
  • Must have a valid driver’s license and Motor Vehicle Record meeting company requirements and guidelines
Knowledge/Skills/Abilities
General: Exceptionally strong analytical and problem-solving skills. Strong ability to communicate, strategize, implement and retain effective business relationships. Exceptional ability to speak and write effectively in a business environment. Ability to maintain an elevated level of accuracy in preparing and entering data. Superb time management and organizational skills with the ability to meet regular and frequent deadlines. Attention to detail required. Ability to work well as a team member. Must demonstrate sound work ethic, flexibility, respectfulness, honesty, and trustworthiness. Must also be punctual and dependable. Must possess cultural awareness and sensitivity. Must be attentive to company goals, timelines, and individual responsibilities to reach those as a team.
Technical: Requires knowledge and understanding of oncology and/or diagnostic imaging equipment. Requires utilizing precision tools to troubleshoot, diagnose, and repair oncology and/or diagnostic imaging systems and parts. Ability to follow written technical directions, read and understand technical drawings, correlate technical documentation and/or instruction to system function and performance. Effective use of Enterprise systems, email, search engine, Internet; ability to effectively use Microsoft Products: Outlook, Word, Excel, Teams; ability to use and understand Enterprise Resource Planning (ERP) software and to use or learn specific software needed to improved productivity.
Communication: Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals. Ability to write effective, collaborative correspondence. Capacity to read through policies, reporting, and compliance requirements. Ability to speak effectively with customers and employees of the organization. Ability to use multiple forms of communication such as e-mail, text, MS Teams, virtual conferencing, Phone, etc. and to understand the method for highest priority or informational communications.
Math amp; Reasoning: Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instruction in mathematical or diagram form and deal with several abstract and concrete variables. Ability to calculate figures and amounts such as discounts, interest, commissions, proportion, percentages, and volume; ability to apply algebraic concepts. Ability to manage multiple projects simultaneously and willingness to adapt to change and take initiative.
Physical and Environmental Elements
Physical Demands: Ability to bend, crouch, kneel, climb, balance, or otherwise maneuver body while servicing and/or inspecting medical equipment. Capacity to reach with hands and arms for at least 1/2 of the normal work shift. Ability to climb stairs, lift, carry, or otherwise move up to 100 lbs while working with medical equipment. Ability to talk or hear continuously. Ability to see clearly to do all work-related tasks (clear or corrected vision at 20 inches or less). Finger dexterity is required frequently for over 3/4 of the normal work shift.
Work Environment: Position is typically performed remotely on customer site with moderate noise levels (examples: hospitals; physician practices, etc.); however, may interact with the production/warehouse environment where temperatures are subject to outdoor conditions in terms of cold and heat. There is exposure to large medical equipment and parts, heavy machinery, and high-voltage electricity, various tools, and equipment, as well as forklift operations and corresponding noise levels. The position will also be subject to an environment of periods of ionizing radiation, high magnetic field, RF (Radio Frequency) signal emissions, high voltages (floating and ground referenced), Inert gasses (i.e.; Helium, Nitrogen, SF6-Sulfur Hexafluoride), Cryogenic Liquids (Helium, Nitrogen), possible biohazards on equipment (excrement, blood, etc. in a patient environment), possible situations of communicable diseases as working in a hospital and/or patient treatment environment, some carcinogenic materials (slip ring dust, depleted uranium in Linac jaws, etc.).
Company Culture
Avante Health Solutions is committed to a respectful and purposeful work environment; this includes each team member taking responsibility for the greater good of the company and its goal to provide exceptional products and service, and to create a sustainable future for the company and its employees. Each team member is expected to strive for excellence in all aspects of their work, as well as actively engage in productive work.
Additionally, Avante Health Solutions is an Equal Opportunity Employer; we proudly promote a diverse workforce and do not discriminate. We encourage all employees and applicants who meet the position requirements to apply for advancement within the organization regardless of race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics. Harassment or inappropriate behavior of any kind is not tolerated and could be grounds for termination.
If assistance or an accommodation due to a disability is needed, please discuss with the hiring manager.