Senior Biocompatibility Engineer

ZOLL Medical•Chelmsford, MA

2d•Hybrid

About The Position

The Senior Biocompatibility Engineer is responsible for the evaluation of medical device products for biological safety. The role is responsible for performing scientifically sound biological 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 Senior Biocompatibility Engineer will apply subject matter expertise to solve complex biomaterials and biocompatibility problems by utilizing technical acumen, business experience, and independent judgment. For current products, this role is responsible for analyzing product material and manufacturing changes and providing 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 oversight, for in vitro and in vivo studies, and authoring final biocompatibility evaluation reports and other biological risk assessments. The Senior Biocompatibility Engineer will function as a key research and development (R&D) team member and collaborate cross-functionally within the business. This person will also support global regulatory submissions.

Requirements

Bachelor’s or Master's Degree or materials science, polymer chemistry and/or analytical chemistry, biomedical engineering or similar field required
5+ years of medical device biocompatibility experience or PhD in biomaterials, materials science, polymer chemistry and/or analytical chemistry, biomedical engineering, or similar field required
Functional expert in the principles of biocompatibility risk assessment for medical devices.
Expert in US and global regulations (e.g., EU, China, Korea, and Japan) and requirements for biocompatibility testing, particularly ISO 10993 and ISO 18562 and related sections of the EU MDR.
Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.

Nice To Haves

Experience in medical device biocompatibility that includes successful initiation and completion of complex biocompatibility projects preferred
Experience in analytical and/or polymer chemistry preferred preferred
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.

Responsibilities

Apply technical expertise to perform complex biomaterials and biocompatibility analyses related to global biocompatibility standards (e.g. ISO 10993 and 18562 series) and regulatory authority requirements for product biological safety.
Plan, manage, and perform biological risk assessments of manufacturing, supplier, and material changes to medical devices and new products with patient contacting components.
Identify and assess business/technical project risks as they relate to biocompatibility and recommend/influence approaches.
Create and defend biocompatibility elements of submissions to global regulatory authorities.
Support on-site and off-site regulatory authority audits for biocompatibility.
Influence, collaborate, and clearly communicate with internal stakeholders (e.g., biocompatibility team, engineers, project managers), and external stakeholders (e.g., consultants, testing labs, 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.
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.