Fresenius Medical Care Job - 33425038 | CareerArc
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Company: Fresenius Medical Care
Location: Waltham, MA
Career Level: Mid-Senior Level
Industries: Healthcare, Pharmaceutical, Biotech

Description

Job ID 20000E6Q

Available Openings 1

PURPOSE AND SCOPE:

The Sr. Biocompatibility Engineer provides biocompatibility related knowledge to be a resource and key technical expert to support all projects. The Sr. Engineer is largely unsupervised and self-motivated to lead projects. Shall be capable of being given high level tasks and working independently to organize work, from required Cross Functional Teams (CFT) and to produce the final reports. The Sr. Engineer is expected to be trusted to provide biocompatibility support to ensure product reliability, dependability and patient safety. The Sr. Engineer also can act as the Subject Matter Expert (SME) in a cross technical team (CTT) to execute a biocompatibility project and/or solve hard problems. The Sr. Biocompatibility Engineer needs experiences dear with FDA requirements and provide support information.

PRINCIPAL DUTIES AND RESPONSIBILITIES:

  • Familiar with Biocompatibility related standards and regulatory guidance, such as ISO/AAMI 10993, MDR, USP, EP and FDA biocompatibility requirements.
  • Is familiar with and follows FDA/ISO Design Control principles and regulations in product development.

  • Subject matter expert (SME) role for biocompatibility study

  • Define biocompatibility requirements for medical device and pharmaceutical products

  • Determine testing and evaluation strategies to assess potential biological safety risks for materials contact with the human body

  • Design chemistry studies to characterize extractable/leachable chemicals from Fresenius' products.

  • Support toxicological risk assessments of extractable/leachable chemicals, and derivation of allowable limits

  • Interface with cross-functional teams for product development, and support project execution and prioritization

  • Partner with internal and external laboratories for new test method development

  • Manage contract laboratory relationships, including cost and quality improvements

  • Participate in development of international standards for biological safety evaluation of medical devices

  • Propagate culture of rigorous science and drive process improvement for biocompatibility group

  • Provide technical leadership and support for issue resolution within biocompatibility group and cross-functional teams

  • Provide assistance to other staff with complex evaluations that require considerable judgment and initiative

  • Applies the education and experience to develop, maintain and resolve any issues with assigned systems of responsibility.

  • Applies Risk based procedures throughout the product development process and the product life cycle.

  • Authors testing plans, test protocol, test reports, and position and/or white papers using good documentation practices

  • Act as a Project Leader for major projects assigned.

  • Participate as a CFT or CTT member as assigned.

  • Develops and gives presentations dealing project status updates.

  • Provide mentoring and assistance to journal level Engineers Review and comply with the Code of Business Conduct and all applicable company policies and procedures, local, state and federal laws and regulations.

  • Works under Minimal supervision and may be asked to contribute to performance evaluations of other employees.

  • Encouraged to generate of idea for potential inventions.

  • Other duties as assigned.

Additional responsibilities may include focus on one or more departments or locations. See applicable addendum for department or location specific functions.


PHYSICAL DEMANDS AND WORKING CONDITIONS:

  • The physical demands and work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

EDUCATION:

  • Bachelor's Degree in related engineering or scientific discipline required; Advanced Degree desirable
  • Travel up to 25%,, Domestic

EXPERIENCE AND REQUIRED SKILLS:

  • 5 – 8 years' related experience;
  • Master's degree with >3 years' related experience;
  • PhD without experience; or equivalent directly related work experience.
  • Define biocompatibility requirements for medical device and pharmaceutical products
  • Determine testing and evaluation strategies to assess potential biological safety risks for materials contact with the human body

  • Design chemistry studies to characterize extractable/leachable chemicals from Fresenius' products.

  • Support toxicological risk assessments of extractable/leachable chemicals, and derivation of allowable limits

  • Interface with cross-functional teams for product development, and support project execution and prioritization

  • Partner with internal and external laboratories for new test method development

  • Manage contract laboratory relationships, including cost and quality improvements

  • Participate in development of international standards for biological safety evaluation of medical devices

  • Propagate culture of rigorous science and drive process improvement for biocompatibility group

  • Provide technical leadership and support for issue resolution within biocompatibility group and cross-functional teams

  • Provide assistance to other staff with complex evaluations that require considerable judgment and initiative

    EO/AA Employer: Minorities/Females/Veterans/Disability/Sexual Orientation/Gender IdentityFresenius Medical Care North America maintains a drug-free workplace in accordance with applicable federal and state laws.


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