Materials Scientist

Materials Scientist

Kelly Scientific Resources is currently seeking a Materials Scientist for one of our top clients near San Antonio, TX.  This company is a consistent leader in its field and is highly respected for its high-quality goods and scope of products and services. This is a full time, direct hire opportunity and all candidates that meet the requirements below are encouraged to apply. 

Position Summary: 

This position is responsible for participating in the innovation and creation of new and novel user solutions.  Key focus areas for this position are bio-compatibility assessments, expertise in ISO 10993 standards, understanding the impact of manufacturing and/or design changes on material properties and product characteristics. 

Essential Duties and Responsibilities:

  • Serve as a SME in materials interactions, be it providing input to bio-compatibility assessments and related testing, understanding effects of manufacturing or processing on the products and/or characterization of candidate materials.
  • Assess and analyze the appropriateness of existing data to support new applications or uses of existing materials and determine if additional data is required.
  • Participation and execution of related regulatory strategy, identification and assessment of novel technologies and new products as well as advancing the understanding of wound healing are also important aspect of this position as a successful candidate is expected to develop and communicate critical aspects associated with the manufacture of and science behind company's products to regulatory agencies, technical colleagues and lay people.
  • Experience developing and driving bio-compatibility and biological safety evaluation strategies with scheduled and defined dependencies between tasks and deliverables for inclusion with worldwide regulatory submissions.
  • Responsible for leading the development of the Biological Safety Evaluation strategy for each device/change
  • Responsible for creating & maintaining procedures related to biological safety evaluation processes
  • Accountable for robust biological safety evaluation outcomes with technical leadership and sound strategies for successful regulatory submissions
  • Participate in design and risk review meetings to address device biological safety concerns and ensure the proper records of biological safety assessments and test plans/reports.
  • Collaborate and clearly communicate with internal and external stakeholders (e.g. Board-Certified Toxicologists, Contract Research Organizations (CROs) to ensure appropriate planning and execution of risk assessments and required testing.
  • Review biocompatibility test results to determine adequacy of data to meet requirements (such as ISO 10993 and other applicable standards) for the biological effects, and utilize problem solving skills and technical knowledge to troubleshoot unexpected results.
  • Serve as the subject matter expert for applicable external standards and regulatory requirements for the biological safety of medical devices.
  • Responsible for working with cross-functional project teams to assess impact of source material, design and manufacturing changes to both current products and those in development.  Provide input and data to minimize risks associated with changes (chemical, physiological, etc.)
  • Support regulatory submissions to global regulatory agencies in areas associated with materials characterization and testing, to include biocompatibility strategy and data in response to additional information requests.
  • Responsible for appropriate input, design, implementation, analysis and reporting of experimental studies
  • Responsible for transferring information gleaned from experiments and technology projects to both technical and non-technical parts of the organization
  • Responsible for appropriate generation and protection of intellectual property
  • Participates in any and all work activities as may be deemed suitable and assigned by management
  • Conforms to, supports and enforces all Company policies and procedures

Education and Experience:

  • Extensive knowledge of FDA and ISO 10993 biological safety requirements and test methods, design controls, verification/validation, Good Laboratory and Good Manufacturing practices (GLP and GMP). REQUIRED.
  • Minimum 7 years’ experience in or with FDA/ISO regulated industry, substantial relevant experience in academic settings during training will be considered in lieu of experience.  
  • Minimum 4 years’ experience participating in development and execution of biocompatibility or biological safety assessments
  • Proven understanding and application of principles, theories and concepts in biocompatibility per ISO 10993
  • Minimum 4 years’ experience working with product development teams to assess impact of manufacturing changes on materials/product characteristics

Preferred Qualifications:

  • PhD with 4 years industry experience and/or MS with 7 years industry experience
  • Knowledge of Food and Drug Administration guidelines and regulations regarding medical devices
  • Industrial experience in development of medical devices, pharmaceutical or combinations devices
  • Knowledge or experience with fluid transport and/or hydraulics a plus
  • Active participation in internal and external scientific standard organizations (ISO, ASTM, etc.)
  • Bachelor’s degree in bioengineering, biomedical engineering, biomaterials, chemical engineering, chemistry, polymer engineering, polymer chemistry, materials science & engineering, mechanical engineering or any technical area leading to skills required to succeed
  • Post-graduate degree a plus

If you are interested in advancing your career with this opportunity, please apply for immediate consideration.

Why Kelly®?

With Kelly, you’ll have access to some of the world’s highest regarded scientific organizations—providing you with opportunities to work on today’s most challenging, research-intensive, and relevant projects. Our connections can lead you to innovative scientific pursuits you’ll be proud to help advance. We work with 90 of the Fortune 100 companies and found opportunities for more than 10,000 scientific professionals last year.

You pursued a career in science to fuel your quest for knowledge and your desire to make the world a better place. Let Kelly fuel your career—connect with us today.

About Kelly®

At Kelly, we’re always thinking about what’s next and advising job seekers on new ways of working to reach their full potential. In fact, we’re a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law.

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