Biomedical Engineer VA
A senior biomedical engineer supports medical device design, testing, documentation and regulatory submissions, working within ISO 13485 and FDA or EU MDR requirements so devices reach market safely and on time.
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Hourly rates · No lock-in contracts
Entry Level
$12 / hr
Intermediate ★
$16 / hr
Senior
$22 / hr
Responsibilities
- Design and develop medical device components and systems in SolidWorks or Creo under design control procedures.
- Prepare design history file documentation including requirements, risk analysis, verification and validation.
- Conduct risk management to ISO 14971 including hazard analysis and FMEA.
- Plan and run verification and validation testing and write test protocols and reports.
- Support regulatory submissions such as FDA 510(k), CE technical documentation under EU MDR and other market registrations.
- Maintain compliance with ISO 13485 quality system requirements throughout the product lifecycle.
- Investigate complaints, non-conformances and CAPAs and support post-market surveillance.
- Evaluate biocompatibility, sterilisation and usability requirements with test laboratories.
- Coordinate with suppliers and manufacturers on device components and process validation.
- Support clinical evaluation and clinical study documentation for the client's regulatory team.
Software & Tools
MATLAB
SolidWorks
LabVIEW
COMSOL
Python
Microsoft Excel
Requirements
- A biomedical, mechanical or electrical engineering degree and 5 or more years in medical device development or engineering.
- Working knowledge of ISO 13485, ISO 14971, IEC 60601 or IEC 62304 and FDA 21 CFR 820 or EU MDR.
- Proficient in SolidWorks or Creo and with document control and quality systems such as Greenlight Guru, MasterControl or Arena.
- Experience writing design control, verification and validation and risk management documents.
- Precise written English for technical documentation that regulators will read.
- Methodical, quality-minded and comfortable working within strict procedures.
- A dependable home office with high-speed internet and backup power, aligned to the client's working hours.
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