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Randstad US biocompatability engineer in chelmsford, Massachusetts

biocompatability engineer.

  • chelmsford , massachusetts (remote)

  • posted 9 days ago

job details

summary

  • $55 - $65 per hour

  • temp to perm

  • bachelor degree

  • category computer and mathematical occupations

  • reference982945

job details

job summary:

100% Remote Position!

Our client in the greater Lowell area is looking to add a Biocompatability Engineer to their growing team for a contract-to-hire opportunity. Candidates interested should have a Bachelor's degree in Material Science, Biomedical Engineering or Chemical Engineering and have at least 5 years of relevant experience. For further detail and immediate consideration please below and call us today. Thank you.

location: Remote, Remote

job type: Contract

salary: $55 - 65 per hour

work hours: 8am to 4pm

education: Bachelors

responsibilities:

Essential Functions:

  • Work closely with program/project cross-functional teams to provide biocompatibility assessments, strategy and deliverables in compliance with global regulatory requirements such as ISO 10993.

  • Plan and manage the impact assessment of manufacturing, supplier, and material changes to medical devices and new products with patient contacting components to ensure biological safety and product sustainability.

  • Identify and assess business/technical project risks and recommend/influence contingency plans for risk mitigation. Apply technical expertise to solve complex biocompatibility problems as related to the ISO 10993 standards and regulatory authority requirements for product safety

  • Support the creation and defense of submissions to global Regulatory Authorities.

  • Collaborate and clearly communicate with internal and external stakeholders (e.g., Board Certified Toxicologists and Contract Research Organizations (CROs) to ensure appropriate planning and execution of risk assessments and required testing.

  • Review, interpret, and summarize raw data from external stakeholders on reports and documents and biological risk assessments using sound scientific principles.

  • Ensure that testing meets all international & domestic test requirements according to ISO, FDA, EU MDR, GLP, Japan, and APAC counties

  • Conduct quantitative risk assessments on chemical characterization profiles as a part of biocompatibility evaluations.

  • Support on-site and off-site Regulatory Authority audits to for product that may be sold in worldwide markets

  • Maintain biocompatibility assessment documents for each production. Ensure the assessment documents are in accordance with the latest version of the standards.

qualifications:

  • Experience level: Experienced

  • Minimum 5 years of experience

  • Education: Bachelors (required)

skills:

  • Biomedical (5 years of experience is required)

Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.

Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility).

For certain assignments, Covid-19 vaccination and/or testing may be required by Randstad's client or applicable federal mandate, subject to approved medical or religious accommodations. Carefully review the job posting for details on vaccine/testing requirements or ask your Randstad representative for more information.

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