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Validation Engineer Biomedical Jobs in Michigan (NOW HIRING)

Stryker

Staff Mechanical Engineer, R&D

Portage, MI · On-site

$89K - $148K/yr

Lead prototyping and testing efforts to validate design performance. * Identify and resolve complex ... Bachelor's degree in Engineering (Mechanical, Biomedical, or related field). * Minimum four years ...

SWS Trimac Inc.

Be Seen First

CNC Lathe Operator / Programmer

Saginaw, MI · On-site

$42K - $75K/yr

Candidate must have a valid driver's license. * Applicant must be a US person as defined by 22 C.F ... biomedical, chemical, defense, and other markets since 1967.

Mitovation

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Systems Engineer - Medical Device Company

Ann Arbor, MI · On-site

$110K - $140K/yr

Develop and execute verification and validation (V&V) test protocols; author associated technical ... Bachelor's degree in Biomedical, Electrical, Mechanical, or Systems Engineering (or related field ...

Recar

PrincipalVehicle Safety Engineer

Troy, MI · On-site

$123K - $185K/yr

Build and maintain test validation plans, including test asset usage, collaboration with test ... Bachelor's degree in mechanical, Automotive, or Biomedical Engineering (Master's preferred) * 10+ ...

Slate Auto

Principal Vehicle Safety Engineer

Troy, MI · On-site

$123K - $185K/yr

Build and maintain test validation plans, including test asset usage, collaboration with test ... Bachelor's degree in mechanical, Automotive, or Biomedical Engineering (Master's preferred) * 10+ ...

Slate Auto

Principal Vehicle Safety Engineer

Troy, MI · On-site

$123 - $185/hr

Build and maintain test validation plans, including test asset usage, collaboration with test ... Bachelor's degree in mechanical, Automotive, or Biomedical Engineering (Master's preferred) * 10+ ...

The Scherdel group

Quality Project Manager

Muskegon, MI · On-site

$95 - $130/hr

Lead qualification, validation, and quality planning activities for new product launches. * Develop ... Bachelor's degree in Engineering, Quality, Manufacturing, Biomedical Engineering, or a related ...

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Validation Engineer Biomedical information

What does a validation engineer do in biomedical?

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 the key skills and qualifications needed to thrive as a validation engineer in biomedical?

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 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 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 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

Electrical Supplier Quality Engineer

Stellantis

Auburn Hills, MI • On-site

Full-time

Re-posted 25 days ago

Stellantis rating

7.5

Company rating: 7.5 out of 10

Based on 131 frontline employees who took The Breakroom Quiz

15th of 45 rated automakers

Job description

The Supplier Quality Development Engineer (SQD) within Stellantis, is accountable to lead and mange suppliers in advance quality planning and process development ensuring suppliers obtain high operational efficiency, are industrialized, and have capable processes which meet Stellantis quality and capacity requirements. SQDs are required work cross functionally with internal and external Engineering, Manufacturing, and Purchasing partners to ensure proper designs, suppliers, and manufacturing processes are selected and refined up to product launch and beyond.
Additionally, they lead supplier problem solving activities and driving change, ensuring best practices & lessons learned are executed across all partners. This includes managing post launch supplier continuous improvement activities in all areas that may impact quality and warranty of our vehicle programs. In many cases the SQD looked at as the technical expert within respect to the manufacturing process of the specific component technology. Typical electrical components in scope are in the advance electronics classification within the following systems: Infotainment, Driver information, ADAS, Safety, Mechatronics, Power Distribution, Starting & Charging, Safety, Sensors & Switches, E-Shifter.
SQD Engineers at Stellantis partner with suppliers to review manufacturing processes, develop quality systems and ensure the highest quality components will be provided for our vehicles. This requires regular visits to, and audits of our supply base creating visibility and utilizing their engineering skills and knowledge to provide a significant impact on the success of our vehicle programs.
At Stellantis we deliver world class results by embracing our values of Belief, Respect, Innovation, Diversity, Growth, and Energy as they are the framework for our culture. We believe in a life-work balance and provide team members opportunities for mentoring, learning & development, and exposure to senior leadership.
Basic Qualifications:
  • Bachelor of Science degree in Electrical, Mechanical (Bachelor of Science degree in Aerospace/Aeronautical, Biomedical/Biomechanical/Bioengineering, Chemical Engineering, or Mechatronics Engineering may be considered) from an ABET accredited program or equivalent program
  • 5 years or more of work experience in automotive engineering, manufacturing, or supplier operations
  • Candidates must have some proven vehicle electronics hardware and or software background. Such as previous experience in automotive product design release, resident engineering, or component manufacturing processes
  • Knowledgeable in APQP, PPAP, PFMEA, and structured problem-solving techniques
  • Proficient interpersonal skills and the ability to work effectively in a cross functional team, with experienced abilities in directing and leading meetings
  • Proven ability to manage multiple supplier projects and tasks
  • Creative problem-solving ability and a results orientation
  • Proficient in using Microsoft Office / Google Suite on the stage of the program or state of the supplier relationship
  • Ability to travel within the USA, Canada, and Mexico regions 20-40% (Typically 25%)

Preferred Qualifications:
  • Master's degree
  • 3 or more years of related engineering experience
  • Knowledgeable in APQP, PPAP, DFMEA, PFMEA
  • Six Sigma Green Belt or Black Belt skills Quality certification
  • Comfortable leading complex electrical component & systems problem root cause analysis
  • Automotive product design release and or system integration experience
  • Automotive electrical systems validation and or vehicle diagnostics experience
  • Manufacturing plant exposure/experience

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