Job details
Salary $60 - $80 an hour job type full-time contract number of hires for this role 1
Qualifications
Bachelor`s (preferred)
Manufacturing: 1 year (preferred)
Us work authorization (preferred)
Full job description
This position will support product and materials development for new and released product, ensuring product safety and reliability through the direction and execution of characterization testingThis will include providing problem solving, materials laboratory testing and data analysis in support of new and existing implantable biomedical devices and systemsBiocompatibility and biostability testing, as well as documenting product equivalence through appropriate characterization testing will also be included.
Conduct laboratory testing and write technical reports to document device/component compliance with necessary regulations and materials characterization requirements.
Guide product development and remediation through the familiarity of international device regulations pertaining to medical devices and materials of concern, including rohs and the european union medical device directive
Support the quality and reliability of released product through comparative testing or root cause characterization testing.
Participate in the analysis of technical issues and the development of recommendations for project decisions and actions
Primary areas of focus include testing for and documenting compliance relating to reach, rohs, iso 10993-1 and other regional standards for medical devices.
Develop biocompatibility strategies and prepare biological evaluation plan.
Coordinates and facilitates biocompatibility testing of materials and designs in accordance with fda requirements, internal sops and standards.
Liaise with internal resources (design, regulatory, quality, clinical and manufacturing) and external resources, developing and coordinating test strategies with contract research organizations (cros) to ensure appropriate planning and execution of required testing.
Perform gap assessments of products by reviewing legacy documentation and evaluating device boms to determine the applicability of test data to iso 10993 standard.
Write biological risk assessments to ensure all the relevant end points mentioned in iso 10993 are met.
Develop and deliver regulatory submission responses to biocompatibility related questions.
Participate in the analysis of technical issues and the development of recommendations for project decisions and actions.
Equal opportunity employer/veterans/disabled
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The company will consider qualified applicants with arrest and conviction
Job types: full-time, contract
Pay: $60.00 - $80.00 per hour
Benefits:
401(k)
Dental insurance
Disability insurance
Health insurance
Life insurance
Referral program
Vision insurance
Schedule:
8 hour shift
Day shift
Monday to friday
Education:
Bachelor`s (preferred)
Experience:
Manufacturing: 1 year (preferred)
Biomedical: 5 years (required)
Biocompatibility: 5 years (required)
Medical device: 5 years (required)
Work location:
Fully remote
Work location: remote
