Staff Biocompatibility Specialist in Mahwah, NJ at Stryker Corporation

Date Posted: 9/26/2019

Job Snapshot

Job Description

Who we want 

  • Dedicated achievers. People who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations.
  • Curious learners. People who seek out cutting-edge research and information to expand and enhance their ability to develop new ideas into reality.
  • Goal-oriented developers. Keeping the customer and requirements squarely in focus, people who deliver safe and robust solutions.

What you will do

As a Staff Biocompatibility Specialist, you will work to support new product development and changes to medical devices currently on the market. You will work to ensure the cleaning, sterilization and biocompatibility process for products meet the current industry guidelines.  You will work closely with operations and product development groups to lead continuous quality improvement initiatives. 

  • Provide input into the development and implementation of ISO10993 biological safety test strategies.
  • Assess test data and write and approve Toxicological/Biocompatibility Assessments and Reports .
  • Maintain communications with internal customers on biocompatibility issues, support problem solving related to chemical risk assessments
  • Work with product development, lab personnel and management on risk assessment findings
  • Compilation of regulatory data packages to FDA/other relevant authorities globally.
  • Develop technical review documents including risk assessments and toxicological data summaries.
  • Support environmental compliance including PROP 65, REACH and ROHS and complete assessments on chemicals that may be present.
  • Support design verification and validation test requirements that ensure appropriate objective evidence is available to support acceptance criteria.
  • Participate in design reviews by identifying risks associated with the product use and tracking how the design, documentation, and manufacturing process mitigate those issues throughout the development process.
  • Implement data analysis and statistical techniques to drive appropriate risk management activities and prioritization of issues.    
  • Ensure effective implementation and compliance to all applicable regulations and standards, including 21CFR820, ISO 13485, ISO 14971 throughout the design and development process.
  • Understanding of the fundamentals of moist heat, gamma irradiation, and ethylene oxide sterilization.

What you need

  • Bachelor’s Degree in Biology, Microbiology, or a closely related life science required.
  • MS with 4+ years of medical device, pharmaceutical or chemical industry preferred
  • Ph.D. in Toxicology or related field with 2+ years of medical device pharmaceutical or chemical industry considered.
  • DABT certification is a plus
  • Experience with critical evaluation of toxicological studies preferred
  • Experience performing risk-based assessments of chemicals under ISO 10993-1 and 17 highly preferred
  • Knowledge of FDA and EU regulatory requirements for pharmaceutical and/or medical device industry
  • Knowledge of cGLP, cGMP, ANSI, AAMI, ISO, FDA, EPA, and USP guidelines to the cleaning, sterilization, bioburden, bacterial endotoxin, and biocompatibility assessment of orthopedic implants and surgical instruments.
  • Some travel may be required (5% - 10%)

Work From Home: No

Travel Percentage: 10%

Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability.

Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.

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