Philips Biological Safety Engineer - Chemistry & Chemical Engineering Candidates Apply

Philips Biological Safety Engineer – Chemistry & Chemical Engineering

Philips is a global leader in health technology, committed to improving billions of lives worldwide and striving to make the world healthier and more sustainable through innovation. Driven by the vision of a better tomorrow.

Job Title: Biological Safety Engineer

Location: Pune

Job Id: 460475

Eligibility Criteria: 

  • Bachelors or Master’s Degree in Material Science, Toxicology, or Chemical Engineering with emphasis on biomaterials, polymers and organic chemistry.
  • Minimum of 5+ year’s professional experience
  • Lab management experience preferred
  • Knowledge of biological test methods for compliance to ISO 10993 and ISO 18562 (desired).
  • Familiarity with FDA 2016 Guidance Document “Use of International Standard ISO 10993-1.”
  • Experience conducting biological assessments of medical devices.
  • Experience documenting biological test evidence to support FDA submittals.
  • Experience working with outside test labs to generate test plans and evaluate results for compliance to biological standards.
  • Understanding of global medical device regulations, requirements, and standards.

In this role, you have the opportunity to be part of Philips Sleep and Respiratory Care as a Biological Safety Engineer focused on Ventilation & related accessory products. You will be responsible for implementing technical strategies, evaluating, and developing products, and providing a superior level of technical support that benefits the organization. The position collaborates closely with Mechanical Engineers, Clinical Affairs, Marketing, Quality & Regulatory in the Ventilation business to develop and commercialize Class 2 medical devices. This position shall provide strategic direction related to the development of systems and programs for the following areas: Microbiology, Cleaning and Biocompatibility testing.

You are responsible for

  • Formulates and executes on biocompatibility and cleaning test plans, protocols, and reports.
  • Establish effective work processes and standardized procedures that ensure compliant documentation of routine testing results and timely completion of business milestones using industry-accepted scientific principles with independent test laboratories.
  • Manage and maintain vendors including supporting audits of the contract facility.
  • Author and review validations and product adoptions into existing cycles.
  • Perform testing and maintains documentation to support the use facility of single-use and reusable products supporting ventilation.
  • Encourage continuous process improvements environment.
  • Additional responsibilities may be assigned, as required, by management.

In addition,

  • Work with a team to assess products for compliance to international biological standards.
  • Document biological test strategies and manage testing with outside test labs.
  • Document biological risk assessments and analyze results from CROs.
  • Learn from and adhere to the internal quality manual (Quality System Procedures, Work Instructions, Forms).
  • Maintain and update current biocompatibility Quality System Procedures, Work Instructions, and Forms.
  • Develop and conduct biocompatibility training programs.
  • Provide weekly project status reports.
  • Prioritize project tasks to complete on schedule while maintaining the quality of work.
  • Work in a team environment; peer review work.
  • Work on multiple, concurrent project

Apply Online

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