Irvine, CA · On-site
$81K - $110K/yr
Perform system integration of mechanical and electrical components. Identify and apply stepper ... Collaborate with cross-functional teams including engineering, quality, manufacturing, and project ...
Quick apply
Irvine, CA · On-site
$81K - $110K/yr
Perform system integration of mechanical and electrical components. Identify and apply stepper ... Collaborate with cross-functional teams including engineering, quality, manufacturing, and project ...
San Diego, CA · On-site
$114K - $182K/yr
Design, develop, integrate, and validate ultrasound imaging systems and subsystems. * Collaborate ... Help translate marketing/customer requirements into engineering specifications. * quality, and ...
San Diego, CA · On-site
$114K - $182K/yr
Design, develop, integrate, and validate ultrasound imaging systems and subsystems. * Collaborate ... Help translate marketing/customer requirements into engineering specifications. * quality, and ...
... quality production processes. Working closely with R&D, QARA, and Production, the X-Ray Engineer ... Comprehensive knowledge of high-voltage insulation systems, creepage and clearance design ...
... quality production processes. Working closely with R&D, QARA, and Production, the X-Ray Engineer ... Comprehensive knowledge of high-voltage insulation systems, creepage and clearance design ...
Maple Grove, MN · On-site
We collaborate with our partners by providing technical expertise in Quality, Regulatory Compliance ... sampling systems / procedures and statistical techniques, verification protocols/testing/reports ...
Maple Grove, MN · On-site
We collaborate with our partners by providing technical expertise in Quality, Regulatory Compliance ... sampling systems / procedures and statistical techniques, verification protocols/testing/reports ...
$120K - $201K/yr
ME/EE/BME/CS degree or equivalent in any engineering/science discipline 3+ years of medical device ... a quality or regulatory system Experience interpreting requirements and following standard ...
$120K - $201K/yr
ME/EE/BME/CS degree or equivalent in any engineering/science discipline 3+ years of medical device ... a quality or regulatory system Experience interpreting requirements and following standard ...
Participate in FDA-related activities and follow quality protocols. * Participate in grant writing ... Proven experience in embedded systems engineering, preferably in the medical device industry.
Quick apply
Participate in FDA-related activities and follow quality protocols. * Participate in grant writing ... Proven experience in embedded systems engineering, preferably in the medical device industry.
Shakopee, MN · On-site
$85K - $103K/yr
Position Summary The role of the Quality Systems Engineer is to create and implement Quality ... Market leading health insurance including medical, dental, vision, and life insurance offerings for ...
Shakopee, MN · On-site
$85K - $103K/yr
Position Summary The role of the Quality Systems Engineer is to create and implement Quality ... Market leading health insurance including medical, dental, vision, and life insurance offerings for ...
Participate in FDA-related activities and follow quality protocols. * Participate in grant writing ... Proven experience in embedded systems engineering, preferably in the medical device industry.
Participate in FDA-related activities and follow quality protocols. * Participate in grant writing ... Proven experience in embedded systems engineering, preferably in the medical device industry.
Shakopee, MN · On-site
$85K - $103K/yr
The Quality Systems Engineer provides training to associates on new or revised Quality systems and ... medical, dental, vision, and life insurance offerings for associates and qualified dependents ...
Shakopee, MN · On-site
$85K - $103K/yr
The Quality Systems Engineer provides training to associates on new or revised Quality systems and ... medical, dental, vision, and life insurance offerings for associates and qualified dependents ...
San Jose, CA · On-site
$103K - $140K/yr
The Quality Systems Engineer will be responsible for the continued development and maintenance of ... Working knowledge of medical device QMS requirements and regulated change implementation.
San Jose, CA · On-site
$103K - $140K/yr
The Quality Systems Engineer will be responsible for the continued development and maintenance of ... Working knowledge of medical device QMS requirements and regulated change implementation.
... medical device environment. This role will play a key part in ensuring equipment and systems are ... Knowledge of GMP, FDA, and quality system requirements * Strong collaboration, communication, and ...
Quick apply
... medical device environment. This role will play a key part in ensuring equipment and systems are ... Knowledge of GMP, FDA, and quality system requirements * Strong collaboration, communication, and ...
$85K - $103K/yr
The Quality Systems Engineer provides training to associates on new or revised Quality systems and ... medical, dental, vision, and life insurance offerings for associates and qualified dependents ...
$85K - $103K/yr
The Quality Systems Engineer provides training to associates on new or revised Quality systems and ... medical, dental, vision, and life insurance offerings for associates and qualified dependents ...
Bothell, WA · On-site
Systems Engineering Lead Roles & Responsibilities: * Act as the onsite Systems Engineering Lead ... Knowledge of medical device quality systems and standards such as ISO 13485, ISO 14971, or ...
Quick apply
Bothell, WA · On-site
Systems Engineering Lead Roles & Responsibilities: * Act as the onsite Systems Engineering Lead ... Knowledge of medical device quality systems and standards such as ISO 13485, ISO 14971, or ...
$120K - $201K/yr
Description The Quality Systems Engineer will develop and execute regulated non-product software ... medical device experience in a quality/regulatory role * Familiarity with 21 CFR Part 11, 21 CFR ...
$120K - $201K/yr
Description The Quality Systems Engineer will develop and execute regulated non-product software ... medical device experience in a quality/regulatory role * Familiarity with 21 CFR Part 11, 21 CFR ...
Arden Hills, MN · On-site
$112K - $146K/yr
... systems engineering, risk management, and cross-functional collaboration to develop safe, reliable, and regulatory-compliant products.The ideal candidate has strong experience in medical device ...
Arden Hills, MN · On-site
$112K - $146K/yr
... systems engineering, risk management, and cross-functional collaboration to develop safe, reliable, and regulatory-compliant products.The ideal candidate has strong experience in medical device ...
Carlsbad, CA · On-site
$75K - $97K/yr
Experience in medical device or other regulated manufacturing environments is preferred ... systems is a plus. * Ability to work effectively with production personnel, engineering, quality ...
Carlsbad, CA · On-site
$75K - $97K/yr
Experience in medical device or other regulated manufacturing environments is preferred ... systems is a plus. * Ability to work effectively with production personnel, engineering, quality ...
Systems Engineer Adjutant Solution Group (ASG) ASG specializes in the development, qualification, and commercialization of drug delivery systems for biomedical products. We deliver integrated ...
Systems Engineer Adjutant Solution Group (ASG) ASG specializes in the development, qualification, and commercialization of drug delivery systems for biomedical products. We deliver integrated ...
Hudson, NH · On-site
The Quality Systems Engineer is responsible for developing, implementing, maintaining, and ... medical condition, genetic information, military or veteran status, gender identity, gender ...
New
Hudson, NH · On-site
The Quality Systems Engineer is responsible for developing, implementing, maintaining, and ... medical condition, genetic information, military or veteran status, gender identity, gender ...
New
Los Angeles, CA · Hybrid
$112K - $154K/yr
The Senior Clinical Systems Engineer is a highly visible role that collaborates with Clinical ... Proven knowledge and experience with Clinical Technology and medical device data systems.
Los Angeles, CA · Hybrid
$112K - $154K/yr
The Senior Clinical Systems Engineer is a highly visible role that collaborates with Clinical ... Proven knowledge and experience with Clinical Technology and medical device data systems.
Systems Engineer At ASG, you will apply core systems engineering processes defined by ISO/IEC 15288, identifying stakeholder needs, defining effective solutions, and ensuring delivered systems ...
Quick apply
Systems Engineer At ASG, you will apply core systems engineering processes defined by ISO/IEC 15288, identifying stakeholder needs, defining effective solutions, and ensuring delivered systems ...
$27.40 - $32.21
5% of jobs
$32.21 - $37.02
14% of jobs
$38.33 is the 25th percentile. Wages below this are outliers.
$37.02 - $41.83
23% of jobs
The median wage is $43.96 / hr.
$41.83 - $46.63
19% of jobs
$46.63 - $51.44
10% of jobs
$52.51 is the 75th percentile. Wages above this are outliers.
$51.44 - $56.25
19% of jobs
$56.25 - $61.06
7% of jobs
$61.06 - $65.87
1% of jobs
$65.87 - $70.67
0% of jobs
$70.67 - $75.48
0% of jobs
$75.48 - $80.29
2% of jobs
$27
$50
$80
For Quality Systems Engineer Medical Device jobs, the most frequently searched job titles are:
Irvine, CA • On-site
$81K - $110K/yr
Contractor
Posted 19 days ago
Job Title: New Product Development (NPD) Engineer – Medical Devices
Location: Irvine, CA 92618
Experience: 5–8 years
Industry: Medical Devices
Job Summary
We are looking for an experienced NPD Engineer to support the development and design of electro-mechanical systems and components for medical device products. The ideal candidate will have strong experience in New Product Development, electro-mechanical design, automation, CAD, and medical device regulatory requirements.
Key Responsibilities
Design and develop electro-mechanical systems, assemblies, and components for new products.
Perform system integration of mechanical and electrical components.
Identify and apply stepper motors, motor drivers, sensors, and PLC programming in product designs.
Support mechanical, electromechanical, and developmental design activities with limited supervision.
Contribute to New Product Development (NPD) projects from concept through development.
Work with industrial automation, robotics, and precision instruments.
Create and modify designs using SolidWorks/CAD and apply GD&T principles.
Support design activities in compliance with Good Manufacturing Practices (GMP) and applicable medical device standards.
Apply knowledge of ISO 13485, Medical Device Regulatory Standards, MDD, and MDR.
Utilize statistical analysis and Design of Experiments (DOE) techniques where applicable.
Prepare and maintain engineering documentation and project-related records.
Collaborate with cross-functional teams including engineering, quality, manufacturing, and project management.
Must-Have Skills
Bachelor's degree in Engineering, Mechanical, Biomedical, Mechatronics, or Electromechanical Engineering.
5–8 years of technical/engineering experience, preferably in NPD and the medical device industry.
Strong experience in product development / New Product Development (NPD).
Hands-on experience with electro-mechanical system and component design.
Experience with SolidWorks/CAD and GD&T.
Knowledge of PLC programming, stepper motors, motor drivers, and sensors.
Experience with industrial automation, robotics, or precision instruments is a plus.
Knowledge of GMP and medical device regulatory requirements.
Working knowledge of ISO 13485, MDD, MDR, and related medical device standards.
Knowledge of DOE and statistical analysis is preferred.
Strong project planning, organizational, communication, and interpersonal skills.
Proficiency with Microsoft Office, Word, Excel, PowerPoint, email, and web-based tools.
Preferred Qualifications
Experience developing regulated medical device products.
Experience working with automated or robotic electro-mechanical systems.
Experience supporting products from concept/design through manufacturing and commercialization.
Strong understanding of engineering documentation and design processes.
Education
Bachelor’s degree in Engineering, Mechanical, Biomedical, Mechatronics, Electromechanical Engineering, or a related technical discipline.
Sourced by ZipRecruiter
Our team of experts first gather each and every requirement of yours. Our research and development team then sit around those requirements and come up with a plan. Our implementation team then executes that plan for optimal results. After that our support team remains in constant touch with you during and after the entire process.
It services
201 - 500 Employees
Edison, NJ, US
2005
