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.)