Clinical Sciences Specialist in Kalamazoo, MI at Stryker Corporation

Date Posted: 2/1/2020

Job Snapshot

Job Description

Who we want

  • Self-directed innovators. People who take ownership of their work and need no prompting to drive productivity, change, and outcomes.
  • Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, data and insights to drive continuous improvement in functions.
  • Analytical problem solvers. People who go beyond just fixing to identify root causes, evaluate optimal solutions, and recommend comprehensive upgrades to prevent future issues.

  • 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.

What you will do

As a Clinical Sciences Specialist, you will provide technical support to various areas of the business related to biocompatibility, cleaning, disinfection and sterilization of reusable and single use medical devices.

Responsibilities include:

  • Develop compliant testing protocols and guidelines for new product development and product changes of both terminally sterilized and reusable products
  • Coordinate and complete projects and project deliverables with general supervision in collaboration with cross functional groups such as R&D, Operations, and Marketing
  • Interpret, assess, analyze and apply international standards related to sterilization, cleaning, disinfection and biocompatibility
  • Work on technical problems of limited scope; understands implications of work and makes recommendations for solutions
  • Participate in the development or revision of quality system procedures and quality improvement initiatives associated with clinical sciences
  • Support resolution to product quality issues such as customer complaints, adverse events, product field actions, and non-conformances
  • Involvement with industry groups such as AAMI, ISO, etc.
  • Perform gap assessments to new or changing standards
  • Knowledge of products and processes within business unit

What you need

  • 0-2 years of experience in medical device product development or testing
  • Knowledge of biocompatibility testing concepts, standards, practices and procedures
  • Knowledge of cleaning, disinfection and sterilization techniques, microbiology concepts, standards, practices and procedures
  • Knowledge of FDA, GMP, ISO, and other medical device regulatory requirements and standards
  • Adequate interpersonal skills with the ability to effectively communicate and lead through influence
  • Strong time management skills, ability to plan and manage multiple priorities
  • Ability to accept and manage project risk to drive concurrent projects forward
  • Working knowledge of business applications such as Microsoft Office (Word, Excel, PowerPoint, etc.)

Work From Home: Not available

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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