Irvine, CA · On-site
$81K - $110K/yr
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 ...
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Irvine, CA · On-site
$81K - $110K/yr
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 ...
Johnson City, TN · Remote
$65K - $73K/yr
Preferred Experience: * Minimum of 3 years Medical Device Regulatory Experience required ... aesthetics experience preferred * Solid understanding of cGMP for Medical Devices, ISO 13485, FDA ...
Johnson City, TN · Remote
$65K - $73K/yr
Preferred Experience: * Minimum of 3 years Medical Device Regulatory Experience required ... aesthetics experience preferred * Solid understanding of cGMP for Medical Devices, ISO 13485, FDA ...
Johnson City, TN · On-site
$65K - $73K/yr
Preferred Experience: * Minimum of 3 years Medical Device Regulatory Experience required ... aesthetics experience preferred * Solid understanding of cGMP for Medical Devices, ISO 13485, FDA ...
Johnson City, TN · On-site
$65K - $73K/yr
Preferred Experience: * Minimum of 3 years Medical Device Regulatory Experience required ... aesthetics experience preferred * Solid understanding of cGMP for Medical Devices, ISO 13485, FDA ...
Aliso Viejo, CA · On-site
Deep knowledge of medical device regulations, supply chain operations, and change control processes. * Strong leadership, communication, and stakeholder engagement skills. * Experience with global ...
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Aliso Viejo, CA · On-site
Deep knowledge of medical device regulations, supply chain operations, and change control processes. * Strong leadership, communication, and stakeholder engagement skills. * Experience with global ...
The Opportunity We currently have several opportunities for the Medical Device Regulatory Affairs Development (RAD) Program to be located in Alameda, Pleasanton, and Santa Clara, CA, Minneapolis, MN ...
New
The Opportunity We currently have several opportunities for the Medical Device Regulatory Affairs Development (RAD) Program to be located in Alameda, Pleasanton, and Santa Clara, CA, Minneapolis, MN ...
New
The Opportunity We currently have several opportunities for the Medical Device Regulatory Affairs Development (RAD) Program to be located in Alameda, Pleasanton, and Santa Clara, CA, Minneapolis, MN ...
New
The Opportunity We currently have several opportunities for the Medical Device Regulatory Affairs Development (RAD) Program to be located in Alameda, Pleasanton, and Santa Clara, CA, Minneapolis, MN ...
New
The Opportunity We currently have several opportunities for the Medical Device Regulatory Affairs Development (RAD) Program to be located in Alameda, Pleasanton, and Santa Clara, CA, Minneapolis, MN ...
New
The Opportunity We currently have several opportunities for the Medical Device Regulatory Affairs Development (RAD) Program to be located in Alameda, Pleasanton, and Santa Clara, CA, Minneapolis, MN ...
New
The Opportunity We currently have several opportunities for the Medical Device Regulatory Affairs Development (RAD) Program to be located in Alameda, Pleasanton, and Santa Clara, CA, Minneapolis, MN ...
New
The Opportunity We currently have several opportunities for the Medical Device Regulatory Affairs Development (RAD) Program to be located in Alameda, Pleasanton, and Santa Clara, CA, Minneapolis, MN ...
New
The Opportunity We currently have several opportunities for the Medical Device Regulatory Affairs Development (RAD) Program to be located in Alameda, Pleasanton, and Santa Clara, CA, Minneapolis, MN ...
New
The Opportunity We currently have several opportunities for the Medical Device Regulatory Affairs Development (RAD) Program to be located in Alameda, Pleasanton, and Santa Clara, CA, Minneapolis, MN ...
New
The Opportunity We currently have several opportunities for the Medical Device Regulatory Affairs Development (RAD) Program to be located in Alameda, Pleasanton, and Santa Clara, CA, Minneapolis, MN ...
New
The Opportunity We currently have several opportunities for the Medical Device Regulatory Affairs Development (RAD) Program to be located in Alameda, Pleasanton, and Santa Clara, CA, Minneapolis, MN ...
New
The Opportunity We currently have several opportunities for the Medical Device Regulatory Affairs Development (RAD) Program to be located in Alameda, Pleasanton, and Santa Clara, CA, Minneapolis, MN ...
New
The Opportunity We currently have several opportunities for the Medical Device Regulatory Affairs Development (RAD) Program to be located in Alameda, Pleasanton, and Santa Clara, CA, Minneapolis, MN ...
New
Moundsview, MN · On-site
$24 - $27/hr
Prepare regulatory documentation and reports Core Duties * Complaint handling & investigation * Medical Device Reporting (MDR) * Adverse event processing * Regulatory compliance support * Safety data ...
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Moundsview, MN · On-site
$24 - $27/hr
Prepare regulatory documentation and reports Core Duties * Complaint handling & investigation * Medical Device Reporting (MDR) * Adverse event processing * Regulatory compliance support * Safety data ...
Our team of medical device specialists, neuroscientists, and consumer electronics engineers is ... This role will help ensure regulatory strategies and deliverables are executed accurately ...
Our team of medical device specialists, neuroscientists, and consumer electronics engineers is ... This role will help ensure regulatory strategies and deliverables are executed accurately ...
Alameda, CA · On-site
Must have 7 years of experiences in Medical Device Regulatory Affairs * Considered as highly experienced with regulatory change assessments. * Working knowledge in US Medical Device Submissions
Alameda, CA · On-site
Must have 7 years of experiences in Medical Device Regulatory Affairs * Considered as highly experienced with regulatory change assessments. * Working knowledge in US Medical Device Submissions
Our team of medical device specialists, neuroscientists, and consumer electronics engineers is ... This role will help ensure regulatory strategies and deliverables are executed accurately ...
Our team of medical device specialists, neuroscientists, and consumer electronics engineers is ... This role will help ensure regulatory strategies and deliverables are executed accurately ...
Stay up to date on regulations and regulatory trends to ensure that practices and procedures remain ... Supports Combination Product and Medical Device inspection readiness and regulatory inspection ...
Stay up to date on regulations and regulatory trends to ensure that practices and procedures remain ... Supports Combination Product and Medical Device inspection readiness and regulatory inspection ...
Develop medical device regulatory submissions in accordance with FDA requirements (e.g., pre-submissions, original IDEs, IDE supplements, 6-month Investigator Lists, original PMAs, PMA supplements ...
Develop medical device regulatory submissions in accordance with FDA requirements (e.g., pre-submissions, original IDEs, IDE supplements, 6-month Investigator Lists, original PMAs, PMA supplements ...
Plantation, FL · On-site
... medical device regulatory submissions in accordance with FDA requirements (e.g., pre-submissions, original IDEs, IDE supplements, 6-month Investigator Lists, original PMAs, PMA supplements, IDE/PMA ...
Plantation, FL · On-site
... medical device regulatory submissions in accordance with FDA requirements (e.g., pre-submissions, original IDEs, IDE supplements, 6-month Investigator Lists, original PMAs, PMA supplements, IDE/PMA ...
Plantation, FL · On-site
... medical device regulatory submissions in accordance with FDA requirements (e.g., pre-submissions, original IDEs, IDE supplements, 6-month Investigator Lists, original PMAs, PMA supplements, IDE/PMA ...
Plantation, FL · On-site
... medical device regulatory submissions in accordance with FDA requirements (e.g., pre-submissions, original IDEs, IDE supplements, 6-month Investigator Lists, original PMAs, PMA supplements, IDE/PMA ...
Food and Drug Administration (FDA) medical device submissions and regulatory compliance activities. * Experience managing multiple regulatory projects in a regulated medical device environment.
Food and Drug Administration (FDA) medical device submissions and regulatory compliance activities. * Experience managing multiple regulatory projects in a regulated medical device environment.
$69K - $80.8K
3% of jobs
$80.8K - $92.6K
11% of jobs
$102.2K is the 25th percentile. Wages below this are outliers.
$92.6K - $104.5K
14% of jobs
$104.5K - $116.3K
10% of jobs
$116.3K - $128.1K
6% of jobs
The median wage is $133.2K / yr.
$128.1K - $139.9K
15% of jobs
$139.9K - $151.7K
6% of jobs
$161.1K is the 75th percentile. Wages above this are outliers.
$151.7K - $163.5K
13% of jobs
$163.5K - $175.4K
6% of jobs
$175.4K - $187.2K
3% of jobs
$187.2K - $199K
13% of jobs
$69K
$137.4K
$199K
For Medical Device Regulatory Attorney 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.
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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
