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Medical Device Validation Engineer Jobs in Wisconsin

Clarios

Senior Cell Validation Engineer

Milwaukee, WI · On-site

The Senior Cell Validation Engineer is responsible for planning, executing and maintaining ... Medical, dental and vision care coverage and a 401(k) savings plan with company matching - all ...

Resonetics

Senior Manufacturing Engineer

Hudson, WI

$78K - $124K/yr

Management of new and existing medical device programs. Responsibilities include maintaining ... Drive process validation and documentation (IQ/OQ/PQ, TMV's, Manufacturing Processes, Equipment ...

Scientific Search

Sr Process Engineer

Racine, WI · On-site

$97K - $126K/yr

Drive innovation in regulated medical device manufacturing * High-visibility role with cross ... Lead manufacturing process improvements, validation, and optimization * Implement new equipment ...

Cadence Inc

Quality Assurance Engineer II

Sturgeon Bay, WI · On-site

$69K - $89K/yr

As a Quality Engineer II for a Contract Medical Device Manufacturing Organization, you will be ... This role analyzes data, generates validation and quality documentation, drives root cause analysis ...

ARCH Global Precision

Regulatory Quality Engineer

Kenosha, WI · On-site

$70K - $90K/yr

Bachelor's degree in applicable technical discipline such as mechanical or bio-medical engineering ... validation of medical device products is required. Equal Opportunity Employer This employer is ...

Resonetics

Senior Manufacturing Engineer

Hudson, WI · On-site

$78K - $124K/yr

Management of new and existing medical device programs. Responsibilities include maintaining ... Drive process validation and documentation (IQ/OQ/PQ, TMV's, Manufacturing Processes, Equipment ...

Resonetics

Senior Manufacturing Engineer

Hudson, WI

$78K - $124K/yr

Management of new and existing medical device programs. Responsibilities include maintaining ... Drive process validation and documentation (IQ/OQ/PQ, TMV's, Manufacturing Processes, Equipment ...

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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:
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Medical Device Validation Engineer jobs near you

Validation and Verification Engineer

Collabera

Madison, WI

Contractor

Medical, Dental, Vision, Life, Retirement, PTO

Re-posted 3 days ago

Job description

Company Description

Established in 1991, Collabera has been a leader in IT staffing for over 22 years and is one of the largest diversity IT staffing firms in the industry. As a half a billion dollar IT company, with more than 9,000 professionals across 30+ offices, Collabera offers comprehensive, cost-effective IT staffing & IT Services. We provide services to Fortune 500 and mid-size companies to meet their talent needs with high quality IT resources through Staff Augmentation, Global Talent Management, Value Added Services through CLASS (Competency Leveraged Advanced Staffing & Solutions) Permanent Placement Services and Vendor Management Programs. 

Collabera recognizes true potential of human capital and provides people the right opportunities for growth and professional excellence. Collabera offers a full range of benefits to its employees including paid vacations, holidays, personal days, Medical, Dental and Vision insurance, 401K retirement savings plan, Life Insurance, Disability Insurance.

Job Description

Position Details: 

Location : Madison, WI 

Job Title : Validation and Verification Engineer

Duration : 12 months (could go beyond)

Local Candidates Only 

Job Description:

Candidates with previous test experience are a HUGE +++ the group is willing to train a candidate, such as a new grad with a Biomed or Electrical/Computer Engineering degree. 

This is a 1 year contract position please ensure your candidates will commit to the full year long position. 

Candidates should be self-driven, be willing to take ownership and be able to deal with complexity - managing multiple projects at one time (the group runs 20K + requirements at any given time. This is a team environment)

Position Description: 

V&V engineering Contractors utilize a combination of structured and creative test approaches to stress the design quality of anesthesia and respiratory care systems with the goal of finding defects in the product design so they can be resolved prior to manufacturing the product.

V&V Engineering Contractors act as key team members interacting with development engineers to understand and analytically stress the functionality, performance, and usability of system features. 

These individuals work hands-on with assembled prototype systems using their engineering skillsets to reverse the problem-solving process to find defects in the product design.


Qualifications

Basic Qualifications: 

High self-confidence 

Excellent communication skills and ability to articulate technical problems in clear and simple terms.

Demonstrated analytical ability and technical competency in Computer Science, Biomedical, Electrical, Mechanical or Computer Engineering areas.

Proven Leadership skills and experience. 

Strong Initiative and ability to work independently and in teams. 

Must be willing to relocate 

Desired Characteristics: 

Prior work experience in design engineering or manufacturing or research experience in the design field

Demonstrated analytic approach to problem solving. 

Proven adaptable to difficult situations.

Demonstrated leadership skills and community involvement.

Prior work experience in automated test design and/or test tool design.

Prior work experience with DOORS, Clearquest, medical device development, C++, C#, or Python programming

Bachelors/Masters degree in Mechanical, Electrical, Computer or Computer Science Engineering or Biomedical Engineering with an emphasis in Mechanical, Electrical or Computer Engineering.

Additional Information

If you are interested please send me your updated copy of resume, to know more about this position:

Ujjwal Mane

973-805-7557

ujjwal.mane(at)collabera.com

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