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Combination Product Medical Device Engineer Jobs in Virginia

Caraballo Consulting & Associates L

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QA Manufacturing Engineer - Medical Device

Sterling, VA · On-site

$40 - $80/hr

... production floor. * Ability to work independently while coordinating effectively with cross ... Medical Device, Pharmaceutical, and Biotec industries, finding qualified personnel.

Caraballo Consulting & Associates L

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QA Manufacturing Engineer - Medical Device

Sterling, VA · On-site

$40 - $80/hr

... production floor. * Ability to work independently while coordinating effectively with cross ... Medical Device, Pharmaceutical, and Biotec industries, finding qualified personnel.

LifeNet Health

Quality Engineer I

Virginia Beach, VA · On-site

$68K - $88K/yr

... the medical device/biologics/tissue combination product industry. This role involves cross-functional initiatives and serving as the Quality Engineering representative in design and production ...

LifeNet Health

Quality Engineer I

Virginia Beach, VA · On-site

$75.84 - $101.12/hr

... the medical device/biologics/tissue combination product industry. This role involves cross-functional initiatives and serving as the Quality Engineering representative in design and production ...

LifeNet Health

Quality Engineer I

Virginia Beach, VA · On-site

$64K - $83K/yr

... the medical device/biologics/tissue combination product industry. This role involves cross-functional initiatives and serving as the Quality Engineering representative in design and production ...

LifeNet Health

Quality Engineer I

Virginia Beach, VA · On-site

$64K - $83K/yr

... the medical device/biologics/tissue combination product industry. This role involves cross-functional initiatives and serving as the Quality Engineering representative in design and production ...

LifeNet Health

Quality Engineer I

Virginia Beach, VA · On-site

$68K - $88K/yr

... the medical device/biologics/tissue combination product industry. This role involves cross-functional initiatives and serving as the Quality Engineering representative in design and production ...

BSI Prof Serv EHS West

This position applies a mix of engineering and design knowledge, newfound regulatory expertise ... to medical device scheme managers, products specialists and the business in the delivery of CE ...

BSI Group

This position applies a mix of engineering and design knowledge, newfound regulatory expertise ... to medical device scheme managers, products specialists and the business in the delivery of CE ...

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All JobsCombination Product Medical Device Engineer JobsCombination Product Medical Device Engineer Jobs in Virginia

Combination Product Medical Device Engineer information

What is a combination product medical device engineer?

Combination Product Medical Device Engineers are professionals who design, develop, and oversee the manufacturing of medical products that integrate drugs, devices, and/or biological components. They ensure these products meet regulatory standards and function safely and effectively for patients. Their work often involves cross-disciplinary collaboration, detailed documentation, and rigorous testing to comply with FDA or other international requirements. These engineers play a crucial role in bringing innovative combination therapies and delivery systems to market.

What are some typical challenges faced by a combination product medical device engineer when working on cross-functional teams?

Combination Product Medical Device Engineers often collaborate with professionals from pharmaceutical, biotechnology, and device engineering backgrounds. One common challenge is ensuring clear communication across disciplines, as each team may have different regulatory requirements and technical needs. Balancing the integration of drug and device components while meeting strict FDA and ISO standards can also be complex. Proactively addressing these challenges through regular cross-functional meetings and thorough documentation helps ensure project success and compliance.

What are the key skills and qualifications needed to thrive as a combination product medical device engineer, and why are they important?

To thrive as a Combination Product Medical Device Engineer, you need a strong background in biomedical or mechanical engineering, familiarity with drug delivery systems, and experience in regulatory standards like FDA 21 CFR and ISO 13485. Proficiency with CAD software, risk management tools, and knowledge of quality management systems (QMS) are typically required, along with certifications such as Six Sigma or PMP being advantageous. Strong problem-solving abilities, attention to detail, and effective cross-functional communication are critical soft skills for excelling in this role. These competencies ensure the development of safe, compliant, and innovative combination products that meet both technical and regulatory requirements.

What is the difference between Combination Product Medical Device Engineer vs Medical Device Quality Engineer?

AspectCombination Product Medical Device EngineerMedical Device Quality Engineer
CredentialsBachelor's or higher in engineering, regulatory knowledgeBachelor's or higher, quality standards expertise
Work EnvironmentDesign, development, and testing of combination productsQuality assurance, compliance, and validation processes
Industry UsagePharmaceutical and medical device sectors involving combination productsMedical device manufacturing and regulatory compliance

The Combination Product Medical Device Engineer focuses on designing and developing products that integrate drugs, devices, or biologics, requiring cross-disciplinary skills. In contrast, the Medical Device Quality Engineer emphasizes ensuring product quality, compliance, and validation throughout manufacturing. Both roles are essential in the medical device industry but serve different stages of product lifecycle and expertise areas.

What are popular job titles related to Combination Product Medical Device Engineer jobs in Virginia?

For Combination Product Medical Device Engineer jobs in Virginia, the most frequently searched job titles are:

What job categories do people searching Combination Product Medical Device Engineer jobs in Virginia look for?

The top searched job categories for Combination Product Medical Device Engineer jobs in Virginia are:

What cities in Virginia are hiring for Combination Product Medical Device Engineer jobs?

Cities in Virginia with the most Combination Product Medical Device Engineer job openings:

Combination Product Medical Device Engineer jobs near you

QA Manufacturing Engineer - Medical Device

Sterling, VA • On-site

Caraballo Consulting & Associates L
See more jobs at Caraballo Consulting & Associates Lexternal

$40 - $80/hr

Contractor

Posted 12 days ago

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Job description

We are seeking a Quality Manufacturing Engineer extensive experience in Medical Devices to oversee Manufacturing Quality projects and line transfers for a Medical Device company.  The perfect candidate will perform the following activities:

Key Responsibilities:

    • Support quality assurance activities associated with transferring and starting up manufacturing operations at the new site.
    • Review, execute, and approve validation documentation, including protocols, test scripts, test data, and final reports.
    • Provide QA oversight for process validation activities to ensure processes are qualified, controlled, and appropriately documented.
    • Support equipment qualification efforts, including IQ, OQ, and PQ activities for manufacturing equipment and related systems.
    • Partner with Manufacturing, Engineering, Validation, and Quality teams to ensure validation deliverables are completed on time and in compliance with applicable procedures and regulations.
    • Assess validation packages for completeness, accuracy, traceability, and adherence to GMP and medical device quality system requirements.
    • Support investigation and resolution of validation-related deviations, discrepancies, and change controls.
    • Generate, review, and approve validation summary reports and supporting documentation for management and quality records.                  
    • Support QA activities associated with the QMS integration of 2 companies.
    • Modify SOPs to complete QMS integration.
    • Complete Change Control activities.
    • Complete the bulk download of documents and records from a Quality Management System.

   Required Qualifications:

  • Bachelor’s degree in Engineering, Quality, Life Sciences, or a related technical discipline, or equivalent relevant experience.
  • Experience in the medical device industry within Quality Assurance, Validation, Manufacturing Quality, or a closely related function.
  • Strong working knowledge of process validation, equipment qualification, and GMP requirements in a regulated manufacturing environment.
  • Demonstrated experience reviewing and approving validation documentation and technical reports.
  • Familiarity with manufacturing operations and the practical application of quality requirements on the production floor.
  • Ability to work independently while coordinating effectively with cross-functional stakeholders.
  • Strong technical writing, documentation review, and problem-solving skills.
  • Excellent attention to detail and ability to manage multiple priorities within a time-bound project.

Company Description

We are a specialized Global staffing firm that works for Fortune 500 companies in the Medical Device, Pharmaceutical, and Biotec industries, finding qualified personnel.