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Medical Device Validation Engineer Jobs in Wisconsin

Compli

Senior Validation Engineer

Milwaukee, WI

Senior Validation Engineer Location : Milwaukee, WI. Lead Projects. Inspire Teams. Build What ... Medical Device and laboratory facilities. Compli differentiates itself through an integrated ...

New

Cadence Inc

Validation Engineer II

Sturgeon Bay, WI ยท On-site

$83K - $105K/yr

... medical device and other advanced industries. We're an engineering company at heart--with over 75 ... We are seeking a highly motivated Validation Engineer onsite at one of our five sites: Cranberry ...

Medline

Validation Engineer

Hartland, WI

$73K - $110K/yr

Validate new and revalidate as appropriate existing equipment used in OTC/Cosmetic and medical device manufacturing. * Perform engineering studies to determine if projects are feasible. * Assist with ...

Medline

Validation Engineer

Hartland, WI ยท On-site

$73K - $110K/yr

Validate new and revalidate as appropriate existing equipment used in OTC/Cosmetic and medical device manufacturing. * Perform engineering studies to determine if projects are feasible. * Assist with ...

Medline

Validation Engineer

Hartland, WI ยท On-site

$73K - $110K/yr

Validate new and revalidate as appropriate existing equipment used in OTC/Cosmetic and medical device manufacturing. Perform engineering studies to determine if projects are feasible. Assist with ...

Medline Industries, LP

Validation Engineer

Hartland, WI ยท On-site

$73K - $110K/yr

Validate new and revalidate as appropriate existing equipment used in OTC/Cosmetic and medical device manufacturing. * Perform engineering studies to determine if projects are feasible. * Assist with ...

Medline

Validation Engineer

Hartland, WI ยท On-site

$73K - $110K/yr

Validate new and revalidate as appropriate existing equipment used in OTC/Cosmetic and medical device manufacturing. * Perform engineering studies to determine if projects are feasible. * Assist with ...

Medline International Two Australia Pty

WI ยท On-site

$73 - $110/hr

Validate new and revalidate as appropriate existing equipment used in OTC/Cosmetic and medical device manufacturing.* Perform engineering studies to determine if projects are feasible.* Assist with ...

Kellton Tech

Medical Device Assembler

Madison, WI ยท On-site

$23 - $24/hr

Job Title: Medical Device Assembler Location: Madison, WI (Onsite) Pay Rate: $23-24/hr on W2 ... Engineering group as required. Working Conditions: Clean, temperature controlled environment.

HonorVet Technologies

Medical Device Technician

Madison, WI ยท On-site

$38K - $48K/yr

Medical Device Technician Location: Madison, WI 53718 Duration: 6+ months of contract with ... Bachelor's degree in engineering or related scientific field. Associate's degree with 2+ years ...

Equiliem

Medical Device Technician

Madison, WI ยท On-site

$32 - $38/hr

Medical Device Technician Madison, WI Pay: $32.00 - $38.00 per hour 26-05847 Job Summary The ... Collaborate with engineering, materials, quality, and operations teams to support manufacturing ...

Kellton Tech

Medical Device Technician

Madison, WI ยท On-site

$38K - $48K/yr

Medical Device Technician Location: Madison, WI (Onsite) Scope of Work: Assemble and test medical ... Bachelor's degree in engineering or related scientific field. Associate's degree with 2+ years ...

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Medical Device Validation Engineer information

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.

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 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 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 popular job titles related to Medical Device Validation Engineer jobs in Wisconsin?

For Medical Device Validation Engineer jobs in Wisconsin, the most frequently searched job titles are:

What job categories do people searching Medical Device Validation Engineer jobs in Wisconsin look for?

The top searched job categories for Medical Device Validation Engineer jobs in Wisconsin are:

What cities in Wisconsin are hiring for Medical Device Validation Engineer jobs?

Cities in Wisconsin with the most Medical Device Validation Engineer job openings:

Medical Device Validation Engineer jobs near you

Senior Validation Engineer

Gahagan & Bryant Associates, Inc.

Milwaukee, WI โ€ข On-site

Full-time

Medical, Dental, Vision, Life, Retirement

Posted yesterday

New

Job description

Job: Senior Validation Engineer
Location: Milwaukee, WI.
Lead Projects. Inspire Teams. Build What Matters.
We serve pharmaceutical companies across the United States, offering a vast array of services that assist companies with exceeding their goals and objectives. In today's world, it's never been more important to understand regulations and quality assurance activities as they relate to operations, vendors, engineering, construction and contractors. In 2020, Compli, LLC became a wholly owned subsidiary of George Butler Associates, Inc. This acquisition allowed Compli, LLC to become part of an integrated network of services where clients have more options to engage an impressive suite of in-house services.
Compli is a full service engineering contracting and consulting services company with a life sciences division specializing in pharma, biotech, API, Medical Device and laboratory facilities. Compli differentiates itself through an integrated approach to engineering, construction commissioning and validation.
Compli is a full service engineering contracting and consulting services company with a life sciences division specializing in pharma, biotech, API, Medical Device and laboratory facilities. We are seeking an experienced Senior/Project Lead Validation Engineer to join our growing team. Compli differentiates itself through an integrated approach to engineering, construction commissioning and validation.
Summary:
The Senior Validation Engineer is responsible for providing technical leadership and engineering expertise in the commissioning, qualification, and validation of facilities, utilities, equipment, systems, cleaning processes, and manufacturing processes within regulated life sciences environments.
What You'll Do:
  • Lead and support commissioning, qualification, and validation activities for facilities, utilities, equipment, systems, cleaning, and manufacturing processes.
  • Develop and execute commissioning and validation lifecycle documentation, including validation plans, protocols, test scripts, reports, and supporting documentation.
  • Develop project-specific commissioning, qualification, and validation strategies based on system requirements, risk, intended use, and regulatory expectations.
  • Provide technical leadership throughout all phases of projects, including greenfield construction, facility renovations, equipment installation, new product development, product launch, and process or system upgrades.
  • Lead and perform system, equipment, and process risk assessments and technical analyses.
  • Review engineering and system documentation to ensure alignment with validation requirements and regulatory expectations.
  • Develop, review, and execute applicable system lifecycle deliverables, including URS, SRS, FRS, DDS, RTM, FAT, SAT, IQ, OQ, PQ, and Final Validation Summary Reports.
  • Author and review validation and qualification protocols, technical reports, operating procedures, and other controlled documentation.
  • Investigate and resolve validation discrepancies, deviations, and technical issues using sound engineering judgment and practical problem-solving approaches.
  • Schedule and coordinate protocol execution with manufacturing, facilities, engineering, quality, project management, contractors, and other project stakeholders.
  • Manage multiple validation projects and priorities while meeting established project milestones and deadlines.
  • Provide technical guidance and mentorship to validation specialists, engineers, and other project team members as appropriate.
  • Serve as a technical resource and Subject Matter Expert (SME) in one or more areas of validation, qualification, or regulatory compliance.
  • Interface confidently and professionally with clients, contractors, management, regulatory and quality personnel, and project teams.
  • Support continuous improvement of validation practices, standards, templates, and execution strategies.
  • Other duties as assigned.
What You'll Bring:
  • Bachelor's degree in a related life sciences or requisite industry training and experience
  • 5 ๏ฟฝ 10 years GMP experience
  • Ability to converse about scientific matters
  • Ability to work independently or in collaboration with others
  • In depth understanding and application of validation principles, concepts, practices and standards
  • Considered a Subject Matter Expert (SME) in one area of validation
  • Proficient in current Good Manufacturing Practices and other applicable regulations
  • Experienced with all pertinent industry best practices (e.g., ISPE) including development and execution of all applicable system life cycle deliverables (e.g., URS, SRS, FRS, DDS, RTM, Unit, Integration, User Acceptance testing, FAT, SAT, Validation Planning, IQ, OQ, PQ, Final Validation Summary Report
  • Demonstrated expertise in at least one aspect of system qualification and regulatory compliance (e.g., EMEA, GCP, GLP, GMP, QSR) and internal requirements employing regulatory guidance and industry standards
  • Excellent written communication skills with emphasis in technical writing
  • Proficient in Microsoft Word, Excel, Power Point and Project
Physical Requirements & Work Environment
  • Ability to work on a computer for extended periods.
  • Ability to sit, stand, and walk project sites for prolonged periods.
  • Must be able to travel to job sites occasionally (minimum once per month).
Why You'll Love Working Here
At Compli, you'll work alongside talented professionals who share your passion for building great things. We offer a people-first culture and a comprehensive benefits package designed to support you personally and professionally, including:
  • Medical, dental, and vision insurance
  • Life, accident, and disability coverage
  • 401(k) with company match
  • Employee Assistance Program (EAP) and wellness initiatives
  • Paid company holidays, floating holidays, and flexible time off
  • Professional development and career advancement opportunities
Join Our Team
If you're ready to work on complex projects and build a career with impact, we'd love to hear from you.
Apply today and grow your future with Compli.
At GBA, we are an Equal Employment Opportunity Employer promoting diversity in our workforce by including all individuals regardless of age, race, religion, color, sex, national origin, marital status, genetic information, sexual orientation, gender identity, gender expression, disability, veteran status, pregnancy status, or any other status protected by law.

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