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Medical Device Validation Engineer Jobs in Wisconsin

Smiths Machine

Quality Engineer II

Kenosha, WI · On-site

$70K - $90K/yr

Bachelor's degree in Quality Engineering, Mechanical Engineering, Biomedical Engineering, or a ... validation of medical device products. Language Ability Ability to read, analyze, and interpret ...

ARCH Global Precision

Quality Engineer II

Kenosha, WI · On-site

$70K - $90K/yr

Bachelor's degree in Quality Engineering, Mechanical Engineering, Biomedical Engineering, or a ... validation of medical device products. Language Ability Ability to read, analyze, and interpret ...

MPE-Inc

Manufacturing Engineer Assembly

Milwaukee, WI · On-site

... medical device products -- from line layout and tooling to full-scale process validation. You'll ... If you want engineering work that's tied directly to medical technology that improves people ...

Kellton Tech

Manufacturing Engineer

Madison, WI · On-site

$73K - $94K/yr

Define and execute verification and validation (V&V) plans. * Provide inputs on manufacturing ... Prior experience in a medical device manufacturing or technical support role is highly desirable.

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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 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

Quality Engineer II

Smiths Machine

Kenosha, WI • On-site

$70K - $90K/yr

Full-time

Re-posted 3 days ago

Job description

Primary Responsibilities

• Self-starter, working independently on assigned projects, leading the team and collaborating with other internal and external parties.
• Plans, coordinates, and directs quality control programs designed to ensure continuous production of products consistent with established FDA and ISO standards.
• Investigates and addresses customer complaints (CAPA) regarding quality.
• Assists with internal/external audits of the Quality Management System (QMS) to ensure compliance to procedural, customer, and regulatory requirements.
• Fully versed in Document Control processes and procedures.
• Assists in reviewing and revising processes within the QMS (Quality Management System).
• Provides inspection activity for products throughout the production cycle.
• Creates, implements, updates and maintains work instructions, partnering with the Engineering and other departments.
• Creates and directs process/equipment validations (IQ, OQ, PQ).
• Reviews customer contracts (purchase orders, regulatory requirements, blueprints).
• Creates PPAP documentation (GR&R, control plans, first article inspection, criteria, etc.).
• Directs workers engaged in inspection and testing activities to ensure continuous control over materials, facilities, and products.
• Trains quality and other departments to achieve quality standards (visual and dimensional).
• Works with suppliers to ensure quality of all purchased parts for company use.
• Helps reduce scrap/waste, cost, time; drives for continuous improvement.
• Reliable, timely, ethical and consistent attendance.
• Travels to another facility and/or customer/vendor sites based on company needs.
• Other duties as assigned.

Qualifications

  • Bachelor’s degree in Quality Engineering, Mechanical Engineering, Biomedical Engineering, or a related field preferred or equivalent experience
  • five to seven years of experience in medical device manufacturing industry and in the quality engineering role, and/or training,
  • or equivalent combination of education and experience.
  • Knowledge of the medical device manufacturing industry is highly preferred.
  •  Experience with CNC machining and mechanical inspection is preferred.
  • Knowledge of ISO 13485 Quality Management System & FDA 21CFR 820 Regulations.
  • Knowledge of Geometric Dimensioning and Tolerancing per ASME Y14.5M.
  • Familiarity with test methods and standards for the design, verification, and validation of medical device products.

Language Ability
Ability to read, analyze, and interpret common scientific and technical manuals, training materials, financial reports, and legal documents (specifically in English). Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community (specifically in English). Ability to communicate effectively with tact, respect and professionalism within all levels of the organization. Must work responsibly with or without supervision using effective communication skills; able to collaborate with various departments and all levels of team members.

Computer Skills
To perform this job successfully, an individual should have professional and working knowledge of Microsoft office and its applications (Word, Excel, Power Point, etc.), e-mail, communication platforms (Zoom, Teams). Knowledge of manufacturing software and ERP systems (EPICOR is strongly preferred).

Certificates and Licenses
No certifications required. Relevant certifications demonstrating applied understanding of medical device quality system requirements, such as AAMI Quality System, Certified ASQ or ISO Lead Auditor and Regulatory Affairs Professional Society (RAPS) preferred. GD&T certifications are highly preferred.

Managing Responsibilities
No direct reports.

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