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Validation Engineer Biomedical Jobs in Michigan (NOW HIRING)

Scheurer Hospital Inc

Biomedical Tech

Pigeon, MI · On-site

$22.25 - $29.25/hr

Biomedical Engineering Biomedical Technician-Full Time Weekdays Scheurer Health is seeking a ... Possess a valid driver license with no restrictions * High school diploma or G.E.D. equivalent.

Scheurer Hospital Inc

Biomedical Tech

Pigeon, MI · On-site

$22.25 - $29.25/hr

Biomedical Engineering Biomedical Technician-Full Time Weekdays Scheurer Health is seeking a ... Possess a valid driver license with no restrictions * High school diploma or G.E.D. equivalent.

Trimedx

Biomedical Technician l

Owosso, MI · On-site

Duties include, but are not limited to, validation and inspection of clinical equipment for ... engineering environment preferred * Travel may be required based on customer or business needs At ...

TRIMEDX Holdings

Biomedical Technician l

Owosso, MI

Duties include, but are not limited to, validation and inspection of clinical equipment for ... engineering environment preferred * Travel may be required based on customer or business needs At ...

Trimedx

Biomedical Technician I

Grand Blanc, MI · On-site

$21.50 - $28.50/hr

Duties include, but are not limited to, validation and inspection of clinical equipment for ... engineering environment preferred * Travel may be required based on customer or business needs At ...

TRIMEDX Holdings

Biomedical Technician I

Grand Blanc, MI

$21.50 - $28.50/hr

Duties include, but are not limited to, validation and inspection of clinical equipment for ... engineering environment preferred * Travel may be required based on customer or business needs At ...

Trimedx

Biomedical Technician II

Detroit, MI · On-site

$25 - $33.25/hr

Valid driver's license required; variable travel requirements depending on primary site that may ... Minimum 3 years' experience working with biomedical equipment in a clinical engineering environment

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All JobsValidation Engineer Biomedical JobsValidation Engineer Biomedical Jobs in Michigan

Validation Engineer Biomedical information

What is the difference between Validation Engineer Biomedical vs Quality Assurance Engineer Biomedical?

AspectValidation Engineer BiomedicalQuality Assurance Engineer Biomedical
CertificationsGMP, ISO, FDA validation certificationsGMP, ISO, audit and compliance certifications
Work EnvironmentDesign, develop, and execute validation protocols for medical devicesDevelop and maintain quality systems, audits, and process improvements
Industry UsagePrimarily in medical device manufacturing and regulatory validationAcross medical device, pharmaceutical, and biotech industries

Validation Engineer Biomedical focuses on ensuring medical devices meet regulatory validation requirements through testing and protocols. Quality Assurance Engineer Biomedical emphasizes maintaining quality systems, compliance, and process improvements. Both roles are essential in the biomedical industry but serve different functions related to validation versus quality assurance.

What are some typical challenges faced by Validation Engineers in the biomedical industry and how can they be addressed?

Validation Engineers in the biomedical field often face challenges such as keeping up with evolving regulatory requirements, managing complex documentation, and ensuring equipment or processes meet stringent quality standards. Navigating audits and working cross-functionally with R&D, manufacturing, and quality assurance teams can also be demanding. To address these challenges, staying current with industry regulations, developing strong organizational and communication skills, and maintaining meticulous records are essential for success and career growth in this role.

What are the key skills and qualifications needed to thrive as a Validation Engineer in Biomedical, and why are they important?

To thrive as a Validation Engineer in Biomedical, you need a solid background in engineering or life sciences, knowledge of regulatory standards (such as FDA or ISO 13485), and experience with validation protocols. Familiarity with technical tools like statistical analysis software, calibration equipment, and documentation systems is essential, and certifications such as Six Sigma or CQE can be advantageous. Strong problem-solving, attention to detail, and effective communication skills help you excel in cross-functional teams and ensure compliance. These skills are crucial for maintaining product quality, meeting regulatory requirements, and ensuring patient safety in biomedical environments.

What does a Validation Engineer do in the biomedical field?

A Validation Engineer in the biomedical industry ensures that equipment, processes, and systems used in the production of medical devices or pharmaceuticals meet regulatory standards and function as intended. Their work involves planning and executing validation protocols, documenting results, and troubleshooting any deviations. This role is crucial for maintaining product quality, patient safety, and compliance with regulatory agencies such as the FDA. Validation Engineers often collaborate with quality assurance, manufacturing, and research teams to establish and maintain validated systems throughout a product's lifecycle.
What are popular job titles related to Validation Engineer Biomedical jobs in Michigan? For Validation Engineer Biomedical jobs in Michigan, the most frequently searched job titles are:
What job categories do people searching Validation Engineer Biomedical jobs in Michigan look for? The top searched job categories for Validation Engineer Biomedical jobs in Michigan are:
What cities in Michigan are hiring for Validation Engineer Biomedical jobs? Cities in Michigan with the most Validation Engineer Biomedical job openings:
Validation Engineer Biomedical jobs near you
Validation Engineer - Manistee Area

Validation Engineer - Manistee Area

The Pivot Group

Manistee, MI • On-site

$76K - $116K/yr

Full-time

This job post has expired today. Applications are no longer accepted.

Job description

Validation Engineer - Manistee Area

Validation Engineer | Manistee, MI

Salary Range: $76,000 - $116,000 depending on experience

Are you a meticulous professional with a passion for excelling in validation engineer? The Pivot Group Network, a West Michigan manufacturing-focused recruiting group, is dedicated to fostering meaningful relationships and supporting career growth. We are collaborating with companies in Manistee seeking experienced Validation Engineers.

We are building our network of talent in this field across West Michigan and the broader manufacturing region Pivot Group Network serves. Our partner companies may or may not have an immediate opening for this exact role today, but we actively look for skilled professionals in the regions where they operate. If there is alignment now or in the near future, we reach out.

The Opportunity

We are working with companies in Manistee that are adding Validation Engineers to their teams. These organizations value quality over speed in hiring. By connecting with us, you position yourself for opportunities that align with what you're looking for.

Key Responsibilities

  • Develop and execute validation protocols (IQ, OQ, PQ) for manufacturing equipment and processes.
  • Perform risk assessments and generate validation plans for new and modified systems.
  • Analyze data and author validation reports summarizing testing results and conclusions.
  • Ensure compliance with regulatory requirements (e.g., FDA, ISO) and internal quality standards.
  • Investigate deviations and out-of-specification results during validation activities.
  • Support change control activities by assessing validation impact for proposed changes.
  • Collaborate with cross-functional teams (e.g., R&D, Quality, Manufacturing) on validation efforts.

Recommended Qualifications

  • Bachelor's degree in engineering or a related scientific discipline.
  • 3+ years of experience in validation within a regulated manufacturing environment (e.g., medical device, pharmaceutical).
  • Demonstrated knowledge of GxP regulations and industry standards (e.g., FDA 21 CFR Part 820, ISO 13485).
  • Experience with various validation activities, including IQ, OQ, PQ for equipment, processes, and software.
  • Strong technical writing skills for authoring and reviewing validation protocols and reports.

Bonus Qualifications

  • Experience with Lean Manufacturing or Six Sigma methodologies.
  • Familiarity with data analysis tools (e.g., JMP, Minitab, Python, R).
  • Project management certification (e.g., PMP, CAPM).
  • Advanced degree in a relevant engineering or scientific field.
  • Experience with automation systems (e.g., PLC, SCADA, DCS).

Job Titles That Should Apply

Validation Engineer, Senior Validation Engineer, Principal Validation Engineer, CSV Engineer, Computer System Validation Engineer, Process Validation Engineer, Equipment Validation Engineer, Software Validation Engineer, Test Engineer (Validation), QA Validation Engineer, Validation Specialist, Validation Lead, Validation Consultant, Validation Analyst, Quality Engineer (Validation), Biomedical Engineer (Validation), Pharmaceutical Validation Engineer, Biotech Validation Engineer, Medical Device Validation Engineer

Why The Pivot Group Network

The Pivot Group Network was founded by manufacturing professionals who've been on both sides of the hiring process. Our clients are strategic—they partner with us because they want real insight into their roles and the people filling them, not a stack of resumes. We focus on match-driven placements built around what actually matters: Commute, Compensation, Culture, and Career trajectory. Learn more at https://www.thepivotgroup.org.

If you're ready to take the next step in your career and connect with a firm that values fit over speed, we invite you to reach out at https://www.thepivotgroup.org. The Pivot Group Network offers resources to support your search—market insights, resume feedback, and interview preparation. As our partnerships grow, we'll reach out with opportunities aligned with your goals. Thank you for considering this approach to career advancement.

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