Biomedical Design Engineer - DHF Assurance
Location : Mahwah NJ US 07430
Job Type : Temp/Contract
Reference Code : 19318-BZ1
Compensation : open - 50-60/h
Hours : Full Time
Required Years of Experience : 5
Required Education : BS Mechanical or Biomedical Engineering
Travel : No
Relocation : No
Job Industry : Medical Devices
Job Description :
- Contract position for a biomedical engineer or mechanical engineer to expedite work related to medical device DHF remediation.
- Review, build and edit technical files and design control documents for medical devices with integrated hardware and software in accordance with QMS system.
- Prepare and review design verification test protocols, procedures and reports.
- Drive risk management file activities and updates inclusive of hazard analysis and DFMEAs and the inform risk management approach for engineering.
- Assist engineering in the compilation of design history files to align with ISO 13485, ISO14971 Risk Management and IEC 60601 or other applicable USFDA and EUMDD regulations.
- Assure all applicable quality decisions are derived from the appropriate risk management document in accordance to the QMS Qualifications.
Required Qualifications :
- BS in Mechanical Engineering or Biomedical Engineering
- Minimum 5 years of experience working in medical device DHF (design history file) assurance.
- Experience in product & process development.
- Proficient with medical device product and process risk management as well as regulations and standards under USFDA and EUMDD.
- Technical skills in test method development and validation.
Contact: Bill Zukowsky