No C2C / Only W2 / No Sponsership Seeking an experienced Senior Design Quality Engineer to support development of complex robotic and electromechanical Class III medical systems. This role leads ...
No C2C / Only W2 / No Sponsership Seeking an experienced Senior Design Quality Engineer to support development of complex robotic and electromechanical Class III medical systems. This role leads ...
Design Quality Engineer, Software Medical Device
Austin, TX · On-site
$100K - $125K/yr
We are looking for a Design Quality Engineer for our software medical device (SaMD) who can partner ... Flexible schedules * Company health care plan * Medical, dental, and vision insurance * Short and ...
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Apply Early
Design Quality Engineer, Software Medical Device
Austin, TX · On-site
$100K - $125K/yr
We are looking for a Design Quality Engineer for our software medical device (SaMD) who can partner ... Flexible schedules * Company health care plan * Medical, dental, and vision insurance * Short and ...
Apply Early
Design Quality Engineer, Software Medical Device
Austin, TX · On-site
$100K - $125K/yr
We are looking for a Design Quality Engineer for our software medical device (SaMD) who can partner ... Flexible schedules * Company health care plan * Medical, dental, and vision insurance * Short and ...
Design Quality Engineer, Software Medical Device
Austin, TX · On-site
$100K - $125K/yr
We are looking for a Design Quality Engineer for our software medical device (SaMD) who can partner ... Flexible schedules * Company health care plan * Medical, dental, and vision insurance * Short and ...
Design Quality Engineer, Software Medical Device
Austin, TX · On-site
$100K - $125K/yr
We are looking for a Design Quality Engineer for our software medical device (SaMD) who can partner ... Flexible schedules * Company health care plan * Medical, dental, and vision insurance * Short and ...
Design Quality Engineer, Software Medical Device
Austin, TX · On-site
$100K - $125K/yr
We are looking for a Design Quality Engineer for our software medical device (SaMD) who can partner ... Flexible schedules * Company health care plan * Medical, dental, and vision insurance * Short and ...
Execute medical device design history file activities to be compliant with applicable regulations ... Responsible for project schedules, budgets, mitigating risks, and efficient solutioning of issues
Execute medical device design history file activities to be compliant with applicable regulations ... Responsible for project schedules, budgets, mitigating risks, and efficient solutioning of issues
Medical Device R&D Engineer
San Jose, CA · On-site
$115K - $175K/yr
... medical device company. Roles and Responsibilities ... Contribute to the design, development, testing, and manufacturing transfer of interventional ...
Medical Device R&D Engineer
San Jose, CA · On-site
$115K - $175K/yr
... medical device company. Roles and Responsibilities ... Contribute to the design, development, testing, and manufacturing transfer of interventional ...
Medical Device R&D Engineer
San Jose, CA · On-site
$115K - $175K/yr
... medical device company. Roles and Responsibilities ... Contribute to the design, development, testing, and manufacturing transfer of interventional ...
Quick apply
Apply Early
Medical Device R&D Engineer
San Jose, CA · On-site
$115K - $175K/yr
... medical device company. Roles and Responsibilities ... Contribute to the design, development, testing, and manufacturing transfer of interventional ...
Apply Early
... and schedules. * Develop, execute, and review architecture documents, design documents ... ISO 14971 - EU Medical Device requirements; Council Directive 93/42/EEC - Medical Electrical ...
... and schedules. * Develop, execute, and review architecture documents, design documents ... ISO 14971 - EU Medical Device requirements; Council Directive 93/42/EEC - Medical Electrical ...
Medical Device Design and Development - Adjunct Faculty - Phoenix, AZ Traditional Campus - (Fall ...
Phoenix, AZ · On-site
Medical Device Design and Development This course introduces students in the Biomedical Engineering master's degree to the process of modern medical device design and production. Students work in ...
Medical Device Design and Development - Adjunct Faculty - Phoenix, AZ Traditional Campus - (Fall ...
Phoenix, AZ · On-site
Medical Device Design and Development This course introduces students in the Biomedical Engineering master's degree to the process of modern medical device design and production. Students work in ...
Engineer Senior, Drug Delivery Medical Device (JP9905)
Thousand Oaks, CA · On-site
$110K - $151K/yr
... and schedules. * Develop, execute, and review architecture documents, design documents ... ISO 14971 - EU Medical Device requirements; Council Directive 93/42/EEC - Medical Electrical ...
Engineer Senior, Drug Delivery Medical Device (JP9905)
Thousand Oaks, CA · On-site
$110K - $151K/yr
... and schedules. * Develop, execute, and review architecture documents, design documents ... ISO 14971 - EU Medical Device requirements; Council Directive 93/42/EEC - Medical Electrical ...
Medical Device Design and Development - Adjunct Faculty - Phoenix, AZ Traditional Campus - (Fall ...
Phoenix, AZ · On-site
Medical Device Design and Development This course introduces students in the Biomedical Engineering master's degree to the process of modern medical device design and production. Students work in ...
Medical Device Design and Development - Adjunct Faculty - Phoenix, AZ Traditional Campus - (Fall ...
Phoenix, AZ · On-site
Medical Device Design and Development This course introduces students in the Biomedical Engineering master's degree to the process of modern medical device design and production. Students work in ...
Sr. Engineer, Medical Device R&D
$115K - $140K/yr
... device developer focused on biologics and regenerative medicine applications and in growth-mode ... This role will lead product design and development projects of new medical devices. REQUIREMENTS ...
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Apply Early
Sr. Engineer, Medical Device R&D
$115K - $140K/yr
... device developer focused on biologics and regenerative medicine applications and in growth-mode ... This role will lead product design and development projects of new medical devices. REQUIREMENTS ...
Apply Early
Medical Device Design and Development - Adjunct Faculty - Phoenix, AZ Traditional Campus - (Fall 202
Phoenix, AZ · On-site
Medical Device Design and Development This course introduces students in the Biomedical Engineering master's degree to the process of modern medical device design and production. Students work in ...
Medical Device Design and Development - Adjunct Faculty - Phoenix, AZ Traditional Campus - (Fall 202
Phoenix, AZ · On-site
Medical Device Design and Development This course introduces students in the Biomedical Engineering master's degree to the process of modern medical device design and production. Students work in ...
Sr Design Engineer
Caledonia, MI · On-site
Execute medical device design history file activities to be compliant with applicable regulations ... Responsible for project schedules, budgets, mitigating risks, and efficient solutioning of issues
Sr Design Engineer
Caledonia, MI · On-site
Execute medical device design history file activities to be compliant with applicable regulations ... Responsible for project schedules, budgets, mitigating risks, and efficient solutioning of issues
The Si Photonics Device Design Engineer will develop high performance Si Photonics devices ... Medical * Dental * Vision * 401(k) * Company paid life insurance * Company paid disability * Paid ...
The Si Photonics Device Design Engineer will develop high performance Si Photonics devices ... Medical * Dental * Vision * 401(k) * Company paid life insurance * Company paid disability * Paid ...
Design medical device mechanical components and packaging. * Perform Design Failure Mode and Effects Analysis (DFMEA) and User Failure Mode and Effects Analysis (UFMEA) * Lead design verification and ...
Design medical device mechanical components and packaging. * Perform Design Failure Mode and Effects Analysis (DFMEA) and User Failure Mode and Effects Analysis (UFMEA) * Lead design verification and ...
Sr. Manager, Medical Device Cyber Security
Chicago, IL · On-site
$150K - $210K/yr
Partner with R&D and engineering teams to embed secure-by-design principles and Secure Software Development Life Cycle (SSDLC) practices into medical device development. * Define and manage the ...
Sr. Manager, Medical Device Cyber Security
Chicago, IL · On-site
$150K - $210K/yr
Partner with R&D and engineering teams to embed secure-by-design principles and Secure Software Development Life Cycle (SSDLC) practices into medical device development. * Define and manage the ...
Silicon Photonics Device Design Engineer
Temecula, CA · Hybrid
$150K - $185K/yr
The Si Photonics Device Design Engineer will develop high performance Si Photonics devices ... Medical * Dental * Vision * 401(k) * Company paid life insurance * Company paid disability * Paid ...
Silicon Photonics Device Design Engineer
Temecula, CA · Hybrid
$150K - $185K/yr
The Si Photonics Device Design Engineer will develop high performance Si Photonics devices ... Medical * Dental * Vision * 401(k) * Company paid life insurance * Company paid disability * Paid ...
Sr. Manager, Medical Device Cyber Security
Chicago, IL · Hybrid
$150K - $210K/yr
Partner with R&D and engineering teams to embed secure-by-design principles and Secure Software Development Life Cycle (SSDLC) practices into medical device development. * Define and manage the ...
Sr. Manager, Medical Device Cyber Security
Chicago, IL · Hybrid
$150K - $210K/yr
Partner with R&D and engineering teams to embed secure-by-design principles and Secure Software Development Life Cycle (SSDLC) practices into medical device development. * Define and manage the ...
Sr. Manager, Medical Device Cyber Security
Chicago, IL · On-site
$150K - $210K/yr
Partner with R&D and engineering teams to embed secure-by-design principles and Secure Software Development Life Cycle (SSDLC) practices into medical device development. * Define and manage the ...
Sr. Manager, Medical Device Cyber Security
Chicago, IL · On-site
$150K - $210K/yr
Partner with R&D and engineering teams to embed secure-by-design principles and Secure Software Development Life Cycle (SSDLC) practices into medical device development. * Define and manage the ...
Flex Schedule Medical Device Design information
See salary details
$21.39 - $28.23
5% of jobs
$34.82 is the 25th percentile. Wages below this are outliers.
$28.23 - $35.07
21% of jobs
$35.07 - $41.91
21% of jobs
The median wage is $44.57 / hr.
$41.91 - $48.75
9% of jobs
$48.75 - $55.59
16% of jobs
$57.30 is the 75th percentile. Wages above this are outliers.
$55.59 - $62.43
11% of jobs
$62.43 - $69.27
6% of jobs
$69.27 - $76.11
7% of jobs
$76.11 - $82.95
2% of jobs
$82.95 - $89.79
1% of jobs
$89.79 - $96.63
0% of jobs
$21
$49
$96
How much do flex schedule medical device design jobs pay per hour?
What is the difference between Flex Schedule Medical Device Design vs Medical Device Quality Assurance?
| Aspect | Flex Schedule Medical Device Design | Medical Device Quality Assurance |
|---|---|---|
| Credentials | Engineering degree, design certifications | Quality certifications, ISO standards |
| Work Environment | Design labs, R&D departments | Quality control labs, manufacturing sites |
| Industry Usage | Product development, innovation | Compliance, testing, validation |
Flex Schedule Medical Device Design focuses on creating and developing new medical devices with flexible working hours, often in design labs. Medical Device Quality Assurance emphasizes ensuring product compliance and safety, typically in quality control environments. Both roles are essential in the medical device industry but differ in their primary functions and work settings.
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Full-time
Posted 14 days ago
Job description
Seeking an experienced Senior Design Quality Engineer to support development of complex robotic and electromechanical Class III medical systems. This role leads Design Controls, risk management, and V&V quality oversight to ensure regulatory compliance and robust product realization across the lifecycle.
Responsibilities:
- Serve as Quality representative and Design Controls lead on cross-functional teams.
- Ensure compliance with FDA QSR (21 CFR 820.30), ISO 13485, MDR/MDD, and global regulations.
- Lead risk management per ISO 14971, including system-level risk analysis, FMEA/SWFMEA, and residual risk evaluation.
- Maintain end-to-end traceability between design inputs/outputs, risk controls, and verification & validation (V&V).
- Review/approve V&V protocols and reports; support tolerance, worst-case, and margin analyses.
- Support IEC 60601-1, IEC 60601-1-2, IEC 80601-2-77 electrical safety/EMC compliance.
- Collaborate on HW/SW integration and ensure compliance with IEC 62304/82304.
- Support supplier qualification, design transfer, and DHF completeness.
- Contribute to IDE, De Novo, PMA submissions.
- Lead CAPA, NCMR, complaint investigations, and root cause analysis.
Qualifications:
- Bachelor's degree in Engineering, Biomedical Engineering, or Life Sciences.
- 7-10 years' experience in Design Quality within medical devices (Class III preferred).
- Strong knowledge of Design Controls, QSR, ISO 13485, ISO 14971.
- Experience with Minitab or statistical analysis tools.
- Familiarity with ESD controls, electrical components handling.
- Strong technical writing, communication, and time management skills.
About CONFLUX SYSTEMS
Sourced by ZipRecruiter
Company size
11 - 50 Employees
Headquarters location
Alpharetta, GA, US
Year founded
2007