ZOLL Medical is a growing, innovation-driven company on the forefront of delivering medical devices to save lives, and software solutions to improve efficiency. With customers in more than 140 countries, we continue to expand our reach, as well as our product offerings. Hospitals, emergency medical services (EMS), and others trust us to provide high-quality products and exceptional customer service. ZOLL products are used every day across the globe to save the lives of people who suffer sudden cardiac arrest. From Real CPR Help® technology—an industry first—to the world’s only wearable defibrillator, our capabilities and features set us apart. But none of this would be possible without the motivation and dedication of ZOLL employees, and we’re invested in their success.
We offer competitive salaries and a comprehensive benefits package. Join our team. It’s a great time to be a part of ZOLL!
The Biocompatibility Engineer is primarily responsible for the evaluation of medical device products for biocompatibility safety. The role is responsible for overseeing the design and implementation of test systems and procedures for biocompatibility testing, performing scientific risk assessments to support design control activities, and evaluating new research and technology initiatives. The Biocompatibility Engineer will apply subject matter expertise to solve complex biocompatibility problems, utilizing technical acumen, business experience and independent judgment.
This role is responsible for developing biological evaluation plans, support material/chemical characterization studies, support and lead at times in-vitro and in-vivo study designs, and authoring final biocompatibility reports and risk assessments.
The Biocompatibility Engineer will function as a key team member collaborating with team members from diverse technical backgrounds across the business. They will oversee a portfolio of related product development and product life cycle projects, and must efficiently execute risk assessments, evaluations, support testing, and reporting, including biocompatibility and product chemical characterization. This person will provide experience and knowledge of product safety data and procedures to support Regulatory submissions and on-site and off-site Regulatory Authority audits, which may be sold in various worldwide markets.
- Work closely with program/project cross-functional teams to provide biocompatibility assessments, strategy and deliverables in compliance with global regulatory requirements such as ISO 10993.
- Plan and manage the impact assessment of manufacturing, supplier, and material changes to medical devices and new products with patient contacting components to ensure biological safety and product sustainability.
- Identify and assess business/technical project risks and recommend/influence contingency plans for risk mitigation. Apply technical expertise to solve complex biocompatibility problems as related to the ISO 10993 standards and regulatory authority requirements for product safety
- Support the creation and defense of submissions to global Regulatory Authorities.
- Collaborate and clearly communicate with internal and external stakeholders (e.g., Board Certified Toxicologists and Contract Research Organizations (CROs) to ensure appropriate planning and execution of risk assessments and required testing.
- Review, interpret, and summarize raw data from external stakeholders on reports and documents and biological risk assessments using sound scientific principles.
- Ensure that testing meets all international & domestic test requirements according to ISO, FDA, EU MDR, GLP, Japan, and APAC counties
- Conduct quantitative risk assessments on chemical characterization profiles as a part of biocompatibility evaluations.
- Support on-site and off-site Regulatory Authority audits to for product that may be sold in worldwide markets
- Maintain biocompatibility assessment documents for each production. Ensure the assessment documents are in accordance with the latest version of the standards.
- Functional expert in the principles of Biocompatibility Risk assessment.
- Expert in US and global regulations (e.g., EU, China, Korea and Japan) and requirements for biocompatibility and safety testing, particularly ISO 10993
- Knowledgeable of applicable ASTM, ISO, FDA, EN, Japan, and APAC standards with an in-depth understanding of ISO 10993 biocompatibility standards
- Knowledgeable of pertinent sections of REACH, the EU MDR, and Proposition 65 (hazardous substances regulations) as well as ICH and FDA Guidance Documents (e.g., Threshold of Toxicological Concern and Use of ISO 10993-1, etc.)
- Experience in pre-clinical science/Biocompatibility testing in medical device, pharmaceutical, or biotechnology industries
- Demonstrated research effectiveness; patents and/or publication in peer review journals, etc. is preferred
- A detailed understanding of the product development process is preferred
- Effective project management and communications skills in a dynamic, matrixed, geographically diverse business environment to meet deadlines and deliver on commitments. Effective in leveraging and/or engaging others to accomplish projects.
- Effectively manages relationships and projects with external stakeholders (e.g. Contract Research Organizations)
- Effective in accurately scoping projects and considering the full impact of decisions and actions taken and in balancing multiple priorities and project deliverables
- Establishes and maintains effective working relationships with coworkers, managers and cross functional teams.
- Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
- Proficient with statistics and Microsoft suite of office applications
Required/ Preferred Education and Experience:
5+ years of experience with a Master’s degree or 3+ years of experience with a PhD degree in biology, biochemistry, toxicology, analytical chemistry or materials science, preferably with a specialism relating to medical devices
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities will be reviewed periodically as duties and responsibilities change with business necessity. Essential and marginal job functions are subject to modification.
ZOLL Medical Corporation appreciates and values diversity. We are an Equal Opportunity Employer M/F/D/V.
ADA: The employer will make reasonable accommodations in compliance with the Americans with Disabilities Act of 1990.