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 ...
Catheter Engineer - Medical Device Design and Manufacturing Company Overview VerAvanti is an innovative medical device company specializing in precision imaging catheters and interventional tools. We ...
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Evening 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 evening medical device design jobs pay per hour?
What key skills and qualifications are needed to thrive as an Evening Medical Device Design Engineer, and why are they important?
What are some common challenges faced when working evening shifts in medical device design teams?
What is an Evening Medical Device Design job?
What is the difference between Evening Medical Device Design vs Night Medical Device Design?
| Aspect | Evening Medical Device Design | Night Medical Device Design |
|---|---|---|
| Work Hours | Typically evening shifts, often from 2 PM to 10 PM | Primarily night shifts, usually from 10 PM to 6 AM |
| Work Environment | Design labs and offices with daytime support | Design labs with overnight team collaboration |
| Certifications | Relevant engineering or design certifications, FDA knowledge | Same as Evening Medical Device Design, with additional night shift safety protocols |
Both roles involve designing medical devices, but the main difference lies in shift timing. Evening Medical Device Design professionals work during late afternoons and evenings, while Night Medical Device Design roles focus on overnight hours. The core skills, certifications, and industry usage are similar, with shift hours being the primary distinction.
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