ZOLL Medical

2 weeks ago

Senior Biocompatibility Engineer

✓ Verified Job

Canonical indexed version, validated from employer's careers page.

Source: Company careers pageValidated by: Fursa AI

Last checked: 10 hours agoStatus: Live

Job Summary

Evaluate medical device products for biological safety by performing biocompatibility risk assessments that support design control. Oversee the planning and execution of biocompatibility test systems and procedures, develop biological evaluation plans for in vitro and in vivo studies, and author biocompatibility evaluation reports. Collaborate cross-functionally with R&D stakeholders and external partners while ensuring testing and submissions align with standards and regulations such as ISO 10993 and ISO 18562, plus GLP and applicable regulatory requirements.

Location: United States

Workplace: Hybrid

Employment Type: Full time

Job Function: Solutions Engineering & Sales Engineering

Seniority: Mid level

Key Responsibilities

•Perform complex biomaterials and biocompatibility analyses aligned to global standards and regulatory requirements for biological safety.
•Plan, manage, and execute biological risk assessments for manufacturing, supplier, and material changes and new patient-contacting components.
•Create and support biocompatibility elements of submissions to global regulatory authorities and participate in audits.
•Support biocompatibility evaluation work for design and development, including developing biological evaluation plans and authoring final reports.
•Manage biocompatibility assessment documents in the electronic document control system and ensure alignment with the latest applicable standards.

Pay and Benefits

Salary: USD 116,600 - 130,000 annually

Key Requirements

•Bachelor’s or Master’s degree in materials science, polymer chemistry, analytical chemistry, biomedical engineering, or a similar field.
•5+ years of medical device biocompatibility experience, or a PhD in biomaterials, materials science, polymer chemistry/analytical chemistry, biomedical engineering, or a similar field.
•Experience initiating and completing complex biocompatibility projects.
•Experience in analytical and/or polymer chemistry.
•Expertise in principles of biocompatibility risk assessment for medical devices.

Experience:5+ yearsMedical devices

Education:Bachelor's in materials science, polymer chemistry and/or analytical chemistry, biomedical engineering

Skills:Independent judgmentProject risk assessmentScientific analysisStakeholder managementWritten and verbal communication

Eligibility

Work Authorization:Authorization required. Sponsorship not provided.

Company Brief

ZOLL Medical

Designs and manufactures medical devices and software for critical care and rescue, including defibrillators, ventilators, CPR feedback systems, and monitoring solutions for hospitals, emergency responders, and public access settings.

Industry: Medical Devices

Company Size: Enterprise (1,001+ employees)

Growth: Established Company

Headquarters: Chelmsford, United States

Founded: 1980

Website LinkedIn

Loading job details...

Preparing the role view and application actions.

ZOLL Medical

2 weeks ago

Senior Biocompatibility Engineer

✓ Verified Job

Canonical indexed version, validated from employer's careers page.

Source: Company careers pageValidated by: Fursa AI

Last checked: 10 hours agoStatus: Live

Job Summary

Location: United States

Workplace: Hybrid

Employment Type: Full time

Job Function: Solutions Engineering & Sales Engineering

Seniority: Mid level

Key Responsibilities

•Perform complex biomaterials and biocompatibility analyses aligned to global standards and regulatory requirements for biological safety.
•Plan, manage, and execute biological risk assessments for manufacturing, supplier, and material changes and new patient-contacting components.
•Create and support biocompatibility elements of submissions to global regulatory authorities and participate in audits.
•Support biocompatibility evaluation work for design and development, including developing biological evaluation plans and authoring final reports.
•Manage biocompatibility assessment documents in the electronic document control system and ensure alignment with the latest applicable standards.

Pay and Benefits

Salary: USD 116,600 - 130,000 annually

Key Requirements

•Bachelor’s or Master’s degree in materials science, polymer chemistry, analytical chemistry, biomedical engineering, or a similar field.
•5+ years of medical device biocompatibility experience, or a PhD in biomaterials, materials science, polymer chemistry/analytical chemistry, biomedical engineering, or a similar field.
•Experience initiating and completing complex biocompatibility projects.
•Experience in analytical and/or polymer chemistry.
•Expertise in principles of biocompatibility risk assessment for medical devices.

Experience:5+ yearsMedical devices

Education:Bachelor's in materials science, polymer chemistry and/or analytical chemistry, biomedical engineering

Skills:Independent judgmentProject risk assessmentScientific analysisStakeholder managementWritten and verbal communication

Eligibility

Work Authorization:Authorization required. Sponsorship not provided.

Company Brief

ZOLL Medical

Industry: Medical Devices

Company Size: Enterprise (1,001+ employees)

Growth: Established Company

Headquarters: Chelmsford, United States

Founded: 1980

Website LinkedIn