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Medical Device Validation Engineer Jobs in Alabama

Laborup

Senior CNC Programmer

Birmingham, AL · On-site

$24.75 - $34/hr

If you're currently programming complex aerospace, defense, medical device, or high-precision components and want to work with cutting-edge equipment, advanced automation, and a growing engineering ...

Laborup

Senior CNC Programmer

Birmingham, AL · On-site

$24.75 - $34/hr

If you're currently programming complex aerospace, defense, medical device, or high-precision components and want to work with cutting-edge equipment, advanced automation, and a growing engineering ...

Laborup

Senior CNC Programmer

Birmingham, AL · On-site

$24.75 - $34/hr

If you're currently programming complex aerospace, defense, medical device, or high-precision components and want to work with cutting-edge equipment, advanced automation, and a growing engineering ...

laborup

Senior CNC Programmer

Birmingham, AL · On-site

$90 - $120/hr

If you're currently programming complex aerospace, defense, medical device, or high-precision components and want to work with cutting-edge equipment, advanced automation, and a growing engineering ...

Laborup

Senior CNC Programmer

Birmingham, AL · On-site

$24.75 - $34/hr

If you're currently programming complex aerospace, defense, medical device, or high-precision components and want to work with cutting-edge equipment, advanced automation, and a growing engineering ...

Laborup

Senior CNC Programmer

Birmingham, AL · On-site

$24.75 - $34/hr

If you're currently programming complex aerospace, defense, medical device, or high-precision components and want to work with cutting-edge equipment, advanced automation, and a growing engineering ...

Laborup

Senior CNC Programmer

Birmingham, AL

$24.75 - $34/hr

If you're currently programming complex aerospace, defense, medical device, or high-precision components and want to work with cutting-edge equipment, advanced automation, and a growing engineering ...

Laborup

Senior CNC Programmer (NX)

Huntsville, AL · On-site

$26 - $35.75/hr

If you're currently programming complex aerospace, defense, medical device, or high-precision components and want to work with cutting-edge equipment, advanced automation, and a growing engineering ...

Laborup

Senior CNC Programmer (NX)

Huntsville, AL · On-site

$26 - $35.75/hr

If you're currently programming complex aerospace, defense, medical device, or high-precision components and want to work with cutting-edge equipment, advanced automation, and a growing engineering ...

Laborup

Senior CNC Programmer (NX)

Huntsville, AL · On-site

$26 - $35.75/hr

If you're currently programming complex aerospace, defense, medical device, or high-precision components and want to work with cutting-edge equipment, advanced automation, and a growing engineering ...

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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 Alabama? For Medical Device Validation Engineer jobs in Alabama, the most frequently searched job titles are:
What job categories do people searching Medical Device Validation Engineer jobs in Alabama look for? The top searched job categories for Medical Device Validation Engineer jobs in Alabama are:
What cities in Alabama are hiring for Medical Device Validation Engineer jobs? Cities in Alabama with the most Medical Device Validation Engineer job openings:
Medical Device Validation Engineer jobs near you

Packaging Engineer

BIOHORIZONS IMPLANT SYSTEMS

Birmingham, AL • On-site

Full-time

Medical, Dental, Vision, Life, Retirement, PTO

Posted yesterday

New

Job description

This position is onsite based in Hoover, AL and is not open to remote work.

We are interested in every qualified candidate who is eligible to work in the United States. However, we are not able to sponsor visas.


The Packaging Engineer is responsible for the design, development, and lifecycle management of packaging and labeling systems for medical devices at BioHorizons, ensuring compliance with corporate procedures, FDA 21 CFR Part 820, EU MDR, and applicable international standards. This role leads packaging development from concept through commercialization, including material selection, design specifications, and manufacturing integration. The Packaging Engineer defines and executes verification and validation strategies to ensure packaging performance, sterility assurance, and distribution robustness.

Additionally, this role is responsible for the development and control of device labeling, including packaging graphics, Instructions for Use, and UDI/barcode implementation, ensuring global regulatory compliance and alignment with product requirements. The position operates cross-functionally to support design transfer, supplier engagement, and continuous improvement of packaging systems throughout the product lifecycle.

Essential Duties and Responsibilities:

  • Contribute to packaging and labeling activities in alignment with U.S. FDA, EU MDR, and other applicable global regulatory requirements.
  • Develop packaging concepts and solutions based on product design inputs, user needs, and manufacturing requirements.
  • Create and maintain packaging and labeling specifications, and support prototype development, design verification, and validation activities.
  • Develop and maintain technical documentation including packaging drawings, manufacturing routers, and bills of materials.
  • Develop and maintain market-specific labeling content, including labels, packaging graphics, and Instructions for Use, in accordance with applicable regulatory and business requirements.
  • Support the qualification of packaging and labeling equipment and software through participation in installation, operational, and performance qualification activities (IQ, OQ and PQ).
  • Contributes to the development and optimization of in-house and outsourced packaging and labeling processes to improve efficiency, consistency, and scalability.
  • Develop and maintain procedures and work instructions related to packaging, labeling, and production support activities.
  • Evaluate packaging technologies, materials, and industry trends to support continuous improvement and innovation.
  • Support risk management activities for packaging and labeling systems, including participation in documentation such as failure mode and effects analyses.
  • Collaborate with production teams, automation engineers, and cross-functional stakeholders to support implementation and ongoing improvement of packaging and labeling solutions.
  • Partner with Manufacturing, Quality Assurance, Regulatory Affairs, Brand Management, Operations, and external suppliers to execute assigned projects and support product lifecycle needs.
  • Complete assessments of state-of-the-art standards and guidance documents related to packaging and labeling, including recommendations for due diligence.

Qualifications:

  • High proficiency in MS Office Suite required.
  • High proficiency in device labeling software required.
  • Proficiency in CAD design software (e.g. SolidWorks) required.
  • Experience with U.S. FDA, EU MDR and ISO requirements for design controls of medical devices required.
  • Demonstrated ability to engage effectively and professionally with internal stakeholders and external customers across all levels of the organization
  • Overnight travel may be necessary.

Education and Experience:

  • Bachelor's degree in Engineering required (Mechanical or BioMedical Engineering preferred)
  • Four to eight (4 - 8) years of experience working as a Medical Device Engineer (Packaging and/or Manufacturing preferred).


Benefits:

  • 2 comprehensive medical plan options to choose from available the first of each month following your date of hire
  • Flexible Spending Account or HSA Account available
  • Vision Benefits
  • Company paid Dental Insurance for employee and dependents
  • Wellness Plan
  • 401k with 5% matching
  • Generous PTO plan including 11 paid holidays, 2 Floating Holidays and Community Service Hours
  • Company paid Short Term Disability
  • Long Term Disability
  • Company provided Life Insurance
  • Paid Parental Leave
  • Casual Dress Code
  • Social events for employees and family

Henry Schein, Inc. is an Equal Employment Opportunity Employer and does not discriminate against applicants or employees on the basis of race, color, religion, creed, national origin, ancestry, disability that can be reasonably accommodated without undue hardship, sex, sexual orientation, gender identity, age, citizenship, marital or veteran status, or any other legally protected status.

Please note that any offer of employment made by BioHorizons is contingent upon the successful completion of a pre-employment background investigation to include a pre-employment drug screen