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Medical Device Validation Engineer Jobs in Missouri

kindeva

Senior Device Engineer

Maryland Heights, MO · On-site

$101K - $138K/yr

... validations, and data analysis. Leads design changes from initiation through design transfer ... Experience in Medical Device or Combination Products Design Controls, Production, Sustaining ...

kindeva

Senior Project Engineer

Bridgeton, MO

$94K - $122K/yr

The Senior Project Engineer partners closely with Operations, Quality, Validation, Engineering ... Experience in pharmaceutical, biotechnology, medical device, or other regulated manufacturing ...

kindeva

Senior Project Engineer

Bridgeton, MO

$94K - $122K/yr

The Senior Project Engineer partners closely with Operations, Quality, Validation, Engineering ... Experience in pharmaceutical, biotechnology, medical device, or other regulated manufacturing ...

kindeva

Senior Project Engineer

Bridgeton, MO

$94K - $122K/yr

The Senior Project Engineer partners closely with Operations, Quality, Validation, Engineering ... Experience in pharmaceutical, biotechnology, medical device, or other regulated manufacturing ...

kindeva

Senior Project Engineer

Bridgeton, MO · On-site

$94K - $122K/yr

The Senior Project Engineer partners closely with Operations, Quality, Validation, Engineering ... Experience in pharmaceutical, biotechnology, medical device, or other regulated manufacturing ...

Biolase, Inc

Firmware Engineer

California, MO · On-site

$120 - $140/hr

Debug, validate, and verify firmware using standard lab tools ... Support software development activities in compliance with IEC and FDA medical device requirements ...

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Medical Device Validation Engineer information

What are some common challenges faced by medical device validation engineers during the validation process?

Medical Device Validation Engineers often encounter challenges such as ensuring compliance with evolving regulatory standards, managing tight project timelines, and coordinating cross-functional teams. Additionally, they must address unexpected technical issues that arise during testing and validation, and meticulously document results to meet quality and audit requirements. Effective communication and adaptability are crucial for successfully navigating these challenges and delivering safe, effective medical devices.

What does a medical device validation engineer do?

A Medical Device Validation Engineer is responsible for ensuring that medical devices meet regulatory and quality standards before they reach the market. They design and execute tests to validate that products perform as intended, documenting procedures and results to comply with industry regulations such as FDA and ISO guidelines. Their work involves collaborating with design, manufacturing, and quality assurance teams to identify risks and verify that devices are safe and effective for use. This role is crucial for patient safety and for a company's ability to market medical products globally.

Are medical device validation engineers in demand?

Medical device validation engineers are in high demand due to the increasing regulation and complexity of medical devices. They play a critical role in ensuring compliance with standards like ISO 13485 and FDA requirements, and their expertise in validation, testing, and quality assurance is sought after in the healthcare industry.

What is the difference between Medical Device Validation Engineer vs Quality Assurance Engineer?

AspectMedical Device Validation EngineerQuality Assurance Engineer
CredentialsEngineering degree, certifications like CQE or validation-specific trainingEngineering or related degree, CQE or QA certifications
Work EnvironmentDesign validation, process validation, testing labsAudits, process improvements, compliance documentation
Industry UsageProduct development, validation phases in medical device manufacturingEnsuring overall product quality, compliance, and process control

The Medical Device Validation Engineer focuses on validating medical devices through testing and process validation, ensuring products meet regulatory standards. In contrast, the Quality Assurance Engineer oversees overall quality systems, audits, and compliance processes. Both roles require similar certifications and work within the medical device industry, but their core responsibilities differ in scope and focus.

What are the key skills and qualifications needed to thrive as a medical device validation engineer?

To thrive as a Medical Device Validation Engineer, you need a strong background in biomedical engineering or a related field, with expertise in validation protocols, regulatory compliance, and risk analysis. Familiarity with technical standards such as ISO 13485, FDA 21 CFR Part 820, and tools like statistical analysis software and validation management systems is essential. Attention to detail, problem-solving abilities, and effective communication are critical soft skills for collaborating with cross-functional teams and ensuring product safety. These skills are crucial to guarantee that medical devices meet regulatory requirements, function safely, and reach the market efficiently.
What are popular job titles related to Medical Device Validation Engineer jobs in Missouri? For Medical Device Validation Engineer jobs in Missouri, the most frequently searched job titles are:
What job categories do people searching Medical Device Validation Engineer jobs in Missouri look for? The top searched job categories for Medical Device Validation Engineer jobs in Missouri are:
What cities in Missouri are hiring for Medical Device Validation Engineer jobs? Cities in Missouri with the most Medical Device Validation Engineer job openings:
Medical Device Validation Engineer jobs near you

Medical Device Technician

Prescott's, Inc

Kansas City, MO • On-site

$23/hr

Other

Medical, Dental, Vision, Retirement, PTO

Re-posted yesterday

Job description

Join the team at Prescott's, Inc. - where quality meets care.
Prescott's is a leading medical device services company, trusted by healthcare professionals across the country. We specialize in the distribution and expert refurbishment of essential medical equipment, including sterilizers, surgical microscopes, pumps, monitors, anesthesia machines, and more. Our mission is to enhance the quality of healthcare by ensuring providers have access to reliable, high-performing equipment. If you're passionate about supporting the frontlines of care through innovation and service, we'd love to have you on our team.
This position will support Pioneer Biomedical -- a subsidiary of Prescott's Inc.
As a Medical Device Technician, you will be responsible for troubleshooting, repairing, and maintaining various medical devices and equipment. Your technical expertise and meticulous attention to detail will be crucial in ensuring that all devices meet industry standards and are safe for use in medical settings.
Responsibilities
  • Repairs, reworks, or calibrates units, subassemblies, or components to meet operational specifications or tolerances.
  • Conducts tests and inspections of products and processes to evaluate quality, performance, and compliance to specification.
  • Reads test schedule, work orders, performance specifications, wiring diagrams, or schematics to determine testing procedure and equipment to be used.
  • Trims and prepares components including but not limited to wire cables, connectors, and resistors by applying solder and various adhesives as specified by prints and procedural documents.
  • Uses a variety of equipment including but not limited to power supplies, multimeters, leak detection/vacuum systems, volt meters, flowtrax testing equipment, ohmmeters, soldering equipment, and a variety of precision hand tools.
  • Performs or inspects component replacement and rework on units, sub-assemblies and repair/exchange assemblies as required.
  • Reads instrument dial or scope, or observes viewing screen, that indicates resistance, capacitance, continuity, and wave pattern or defect, such as short circuit or current leakage.
  • Compares instrument reading or monitor display with standards and rejects defective units.
  • Confers with technicians, production supervisor, and others regarding testing procedures and results to resolve problems.
  • Examines component, subassembly, or part for defects.
  • May analyze and troubleshoot test results on defective units to determine cause of failure.
  • Be able to navigate software systems and input data.
  • Adjusts, repairs, or replaces electronic component parts to correct defects and to ensure conformance to specifications.
  • Explains assembly testing procedures or techniques to other workers as needed.
Requirements
  • High school diploma or equivalent preferred but not required. Specific Job training will be provided.
  • Previous medical device assembly experience preferred.
  • Computer/ Data Entry experience is essential.
  • Knowledge of quality standards.
  • Computers and Electronics - Knowledge of circuit boards, processors, chips, electronic equipment, and computer hardware and software, including applications and programming.
  • English Language - Knowledge of the structure and content of the English language including the meaning and spelling of words, rules of composition, and grammar.
  • Mechanical - Knowledge of machines and tools, including their designs, uses, repair, and maintenance.
  • Ability to read and work from drawings, blueprints, schematics, wiring diagrams and written instructions with limited supervision.
  • Ability to use a variety of equipment including but not limited to power supplies, multimeters, leak detection/vacuum systems, volt meters, ohmmeters, soldering equipment, and a variety of precision hand tools.

Pay Rate: $23.00 per hour
Benefits
What we offer:
At Prescott's Med, we prioritize your well-being and growth with a comprehensive benefits package including:
* Eligible to participate in our Technician Incentive Plan after 90 days of employment
* Paid time off
* Healthcare insurance (medical dental, and vision coverage)
* Accident insurance, critical illness, and hospital indemnity insurance
* Short term (employee paid) and long-term disability (employer paid)
* 401K plan with company matching.
* Continuous learning and development - offering opportunities for training, workshops, and certifications.
* Our fun and inclusive work environment celebrates diversity and fosters growth, making every day an opportunity to thrive

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