Opportunity is here


Principal Biocompatibility Engineer

ZOLL Medical Corporation

ZOLL Medical Corporation

Chelmsford, MA, USA
Posted on Wednesday, November 22, 2023
Resuscitation, ZOLLMED.com

At ZOLL, we're passionate about improving patient outcomes and helping save lives.

We provide innovative technologies that make a meaningful difference in people's lives. Our medical devices, software and related services are used worldwide to diagnose and treat patients suffering from serious cardiopulmonary and respiratory conditions.

The Resuscitation division of ZOLL Medical Corporation develops and delivers innovative lifesaving products and software solutions to EMS, hospital, public safety, and military customers globally. Our dedicated employees take pride in their commitment to improving patient outcomes while delivering world-class customer service.

At ZOLL, you won’t just have a job. You’ll have a career—and a purpose.

Join our team. It’s a great time to be a part of ZOLL!

Job Summary:

The Principal Biocompatibility Engineer is a highly experienced technical leader responsible for leading cross-functional team members and external partners in the evaluation of medical device products for biological safety. The role is responsible for performing scientific risk assessments to support design control activities, providing oversight in the design and implementation of test systems and procedures for biocompatibility testing, and evaluating materials associated with new research and development initiatives. The Principal Biocompatibility Engineer applies extensive subject matter expertise to solve complex biomaterials and biocompatibility problems by utilizing technical acumen, business experience, and independent judgment. This role is responsible for developing strategies for and analyzing product material changes and providing materials guidance that may include the early evaluations/testing of materials. For finished product designs, the role is also responsible for developing biological evaluation plans, supporting material/chemical characterization studies, supporting and providing technical leadership and oversight for in-vitro and in-vivo studies, and reviewing and authoring final biocompatibility reports and risk assessments.

The Principal Biocompatibility Engineer will function as a key research and development (R&D) technical leader, team member and collaborate cross-functionally within the business. This person will oversee a portfolio of related product development and product life cycle projects and will execute risk assessments and evaluations as well as support testing and reporting, including biocompatibility, and product chemical characterization. This person will also support global regulatory submissions.

Essential Functions:

  • Lead the development of biological safety test strategies and plans for products, whether for new products or product updates/changes.

  • Apply deep technical expertise to lead and perform complex biomaterials and biocompatibility analyses related to global biocompatibility standards and regulatory authority requirements for product biological safety.

  • Plan, manage, and perform assessments of manufacturing, supplier, and material changes to medical devices and new products with patient contacting components to ensure biological safety and product sustainability.

  • Represent the organization as the primary project and technical point of contact on external biocompatibility engagements.

  • Provide materials and biocompatibility assessments, strategies, and deliverables in compliance with global regulatory requirements such as ISO 10993 and ISO 18562.

  • Identify and assess business/technical project risks and recommend/influence approaches.

  • Lead, and in many cases prepare, the creation and defense of the biocompatibility elements of submissions to global regulatory authorities.

  • Influence, collaborate, and clearly communicate with internal stakeholders (e.g., vice presidents, program directors, and project managers), and external stakeholders (e.g., consultants, testing labs, board certified toxicologists and contract research organizations) to ensure appropriate planning and execution of risk assessments and required testing.

  • Review, interpret, and summarize data as needed from reports and documents and biological risk assessments using sound scientific principles.

  • Ensure that testing meets international and domestic biocompatibility test requirements according to ISO, Good Laboratory Practices (GLP), FDA, EU MDR, Japan, and APAC countries.

  • Lead, and in some cases, conduct quantitative risk assessments on chemical characterization profiles as a part of biocompatibility evaluations.

  • Support on-site and off-site regulatory authority audits for products that may be sold globally.

  • Manage biocompatibility assessment documents for each product in ZOLL’s electronic document control system. Ensure the assessment documents are in accordance with the latest version of the standards, where applicable.

Skill Requirements:

  • Functional expert in the principles of material science and in biocompatibility risk assessment for medical devices.

  • Experience in technical leadership of biocompatibility projects from initiation to completion.

  • Expert in US and global regulations (e.g., EU, China, Korea, and Japan) and requirements for biocompatibility testing, particularly ISO 10993 and ISO 18562.

  • Knowledgeable of applicable ASTM, ISO, FDA, EN, Japan, and APAC standards with an in-depth understanding of ISO 10993 and ISO 18562 biocompatibility standards.

  • Knowledgeable of relevant 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.)

  • A detailed understanding of the medical device product development process is preferred.

  • Experience managing projects with ability to engage and leverage others to accomplish tasks and complete deliverables.

  • Effective in scoping projects considering the impact of decisions and actions taken and in balancing multiple priorities and project deliverables.

  • Effective relationship management with internal and external stakeholders.

  • •Effective relationship management with coworkers, managers, and cross functional team members.

  • Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.

  • Proficient with statistics and the Microsoft suite of office applications.

Required/ Preferred Education and Experience:

  • BS and MS required in materials science, chemistry, biochemistry, biomedical engineering or similar field; PhD preferred. Ten or more years of biocompatibility of materials related experience including biomaterials, materials science, polymer chemistry and/or analytical chemistry. Demonstrated research and/or commercial experience in medical device biocompatibility that includes successful initiation and completion of complex biocompatibility projects.

  • Experience in polymer chemistry preferred.

Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

  • Standing - Occasionally

  • Walking - Occasionally

  • Sitting - Constantly

  • Talking - Occasionally

  • Hearing - Occasionally

  • Repetitive Motions - Frequently

ZOLL is a fast-growing company that operates in more than 140 countries around the world. Our employees are inspired by a commitment to make a difference in patients' lives, and our culture values innovation, self-motivation and an entrepreneurial spirit. Join us in our efforts to improve outcomes for underserved patients suffering from critical cardiopulmonary conditions and help save more lives.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.