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 ยท On-site
$100K - $125K/yr
We are looking for a Design Quality Engineer for our software medical device (SaMD) who can partner closely with engineering, clinical, regulatory, and product teams to build practical, audit-ready ...
Quick apply
Design Quality Engineer, Software Medical Device
Austin, TX ยท On-site
$100K - $125K/yr
We are looking for a Design Quality Engineer for our software medical device (SaMD) who can partner closely with engineering, clinical, regulatory, and product teams to build practical, audit-ready ...
Design Quality Engineer, Software Medical Device
Austin, TX ยท On-site
$100K - $125K/yr
We are looking for a Design Quality Engineer for our software medical device (SaMD) who can partner closely with engineering, clinical, regulatory, and product teams to build practical, audit-ready ...
Design Quality Engineer, Software Medical Device
Austin, TX ยท On-site
$100K - $125K/yr
We are looking for a Design Quality Engineer for our software medical device (SaMD) who can partner closely with engineering, clinical, regulatory, and product teams to build practical, audit-ready ...
Design Quality Engineer, Software Medical Device
$100K - $125K/yr
We are looking for a Design Quality Engineer for our software medical device (SaMD) who can partner closely with engineering, clinical, regulatory, and product teams to build practical, audit-ready ...
Design Quality Engineer, Software Medical Device
$100K - $125K/yr
We are looking for a Design Quality Engineer for our software medical device (SaMD) who can partner closely with engineering, clinical, regulatory, and product teams to build practical, audit-ready ...
Medical Device R&D Engineer
San Jose, CA ยท 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 ยท 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 ยท On-site
$115K - $175K/yr
... medical device company. Roles and Responsibilities ... Contribute to the design, development, testing, and manufacturing transfer of interventional ...
Quick apply
Medical Device R&D Engineer
San Jose, CA ยท On-site
$115K - $175K/yr
... medical device company. Roles and Responsibilities ... Contribute to the design, development, testing, and manufacturing transfer of interventional ...
Execute medical device design history file activities to be compliant with applicable regulations * Conduct the development and evaluation of medical device designs which meet defined product ...
Execute medical device design history file activities to be compliant with applicable regulations * Conduct the development and evaluation of medical device designs which meet defined product ...
Medical Device Design and Development - Adjunct Faculty - Phoenix, AZ Traditional Campus - (Fall ...
Phoenix, AZ ยท 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 ยท 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 ยท 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 ยท 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 ...
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 ...
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 ...
Develop, execute, and review architecture documents, design documents, specifications, development ... ISO 14971 - EU Medical Device requirements; Council Directive 93/42/EEC - Medical Electrical ...
Develop, execute, and review architecture documents, design documents, specifications, development ... ISO 14971 - EU Medical Device requirements; Council Directive 93/42/EEC - Medical Electrical ...
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 ...
Quick apply
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 ...
Design characterization, verification execution. * Device design experience (design for six sigma ... ISO 14971 - EU Medical Device requirements; Council Directive 93/42/EEC - Medical Electrical ...
Design characterization, verification execution. * Device design experience (design for six sigma ... ISO 14971 - EU Medical Device requirements; Council Directive 93/42/EEC - Medical Electrical ...
Sr. Manager, Medical Device Cyber Security
Chicago, IL ยท 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 ยท 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. Engineer, Device Development
Bedford, MA ยท On-site
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. Engineer, Device Development
Bedford, MA ยท On-site
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 ...
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 ...
Silicon Photonics Device Design Engineer
Temecula, CA ยท 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 ยท 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 ยท 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 ยท 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 ยท 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 ยท 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 Design Engineer
Caledonia, MI ยท On-site
Execute medical device design history file activities to be compliant with applicable regulations * Conduct the development and evaluation of medical device designs which meet defined product ...
Sr Design Engineer
Caledonia, MI ยท On-site
Execute medical device design history file activities to be compliant with applicable regulations * Conduct the development and evaluation of medical device designs which meet defined product ...
Locum Medical Device Design information
What are some common challenges faced by locum medical device design professionals when integrating into new teams and projects?
What are the key skills and qualifications needed to thrive as a Locum Medical Device Designer, and why are they important?
What is the difference between Locum Medical Device Design vs Contract Medical Device Engineer?
| Aspect | Locum Medical Device Design | Contract Medical Device Engineer |
|---|---|---|
| Credentials | Relevant engineering degrees, certifications in medical device design | Same as locum, often with specialized certifications |
| Work Environment | Temporary assignments in various companies or projects | Project-based, often in corporate or manufacturing settings |
| Employer & Industry Usage | Used by staffing agencies, hospitals, and medical device firms | Engaged by companies for specific projects or product development |
Both roles involve designing medical devices, requiring similar credentials and working in related environments. The key difference is that a locum medical device designer works temporarily across different organizations, while a contract medical device engineer is typically hired for specific projects within a single company.
What are locum medical device design professionals?
- Full Time Medical Device Reprocessing
- Medical Device Development Engineer
- Medical Device Sales Manager
- Medical Sales Associate
- Internship Remote Medical Device Sales
- Senior Complaint Handling Medical Device
- Medical Device Regulatory Compliance
- Afternoon Medical Device Startup
- Medical Device Production
- Medical Device Sales Support
Full-time
Posted 11 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