Job Title: Senior Biocompatibility Engineer
Company Overview:
Pulivarthi Group is a premier global provider of staffing and IT technology solutions, renowned for delivering exceptional services tailored to each client's unique needs. With a steadfast commitment to excellence, we merge expertise with innovation, ensuring cost-effective solutions of the highest quality. Our diverse client base spans healthcare, finance, government, and beyond, reflecting our adaptability and proficiency across industries. Operating in the United States, Canada, and Mexico, we pride ourselves on aligning with clients' cultures, deploying top-tier talent, and utilizing cutting-edge technologies. Pulivarthi Group stands as a beacon of reliability, efficiency, and innovation in the realm of staffing solutions.
Job Overview/Summary:
We are seeking a dedicated Senior Biocompatibility Engineer to lead the planning, execution, evaluation, and documentation of biocompatibility studies to ensure product safety. This remote position involves close collaboration with cross-functional teams to develop test protocols, analyze data, and ensure compliance with global regulatory standards, particularly ISO 10993.
Responsibilities:
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Plan, execute, evaluate, and document biocompatibility studies and justifications to support product safety.
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Develop comprehensive test campaigns, protocols, reports, regulatory summaries, and verify methods and results in collaboration with project teams and test laboratories.
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Partner with cross-functional project team members to define evaluation and verification strategies for medical devices.
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Recommend approaches and support updating or developing internal procedures that comply with applicable global regulatory requirements.
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Identify and analyze materials, design, and process challenges to achieve optimal solutions related to biological safety.
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Identify critical process factors and their effects on biological safety.
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Develop and execute project plans, including defining scope, timelines, critical path management, resources, and budget concerning biocompatibility.
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Interface with key business partners and act as a biocompatibility subject matter expert on new product development teams.
Primary Skills:
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Bachelor's Degree in Engineering or Science.
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Minimum of 2 years of experience in biological sciences or biocompatibility within the medical device industry.
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Direct experience in the biological evaluation of medical devices per ISO 10993.
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Strong analytical skills and attention to detail.
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Knowledge of design controls within a regulated industry.
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Excellent verbal and written communication skills, with the ability to interact effectively and professionally in a global team environment.
Secondary Skills (Good to Have):
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Bachelor's Degree in Engineering or Science with a focus in Chemistry or Biological Sciences.
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Experience with risk management and quality assurance processes.
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Proficiency in project management and data analysis.
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Familiarity with technical writing and regulatory compliance.
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Experience in material selection and problem-solving related to biocompatibility.
Qualifications:
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Demonstrated experience in biological evaluation and biocompatibility testing of medical devices.
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Strong understanding of ISO 10993 standards and their application in medical device development.
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Ability to work collaboratively with cross-functional teams and manage multiple projects effectively.
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Commitment to maintaining confidentiality and data security.
Benefits/Perks:
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Competitive salary and comprehensive benefits package.
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Opportunities for professional development and career advancement.
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Collaborative and innovative work environment.
