Zollmedicalcorp

Senior Biocompatibility Engineer

Chelmsford, MA · Senior

No sponsorship$117k-$130kDetected 14 days ago
FDA RegulatoryMedical DevicesResearchAnimal StudiesCommunication

About the role

  • The Senior Biocompatibility Engineer is responsible for the evaluation of medical device products for biological safety.
  • 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.

Responsibilities

  • 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.
  • 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.

Requirements

  • 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.
  • Experience managing projects with ability to engage and leverage others to accomplish tasks and complete deliverables.
  • Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.

Nice to have

  • Identify and assess business/technical project risks as they relate to biocompatibility and recommend/influence approaches.
  • Ensure that testing meets international and domestic biocompatibility test requirements according to ISO, Good Laboratory Practices (GLP), FDA, EU MDR, Japan, and APAC countries.
  • Bachelor's or Master's Degree or materials science, polymer chemistry and/or analytical chemistry, biomedical engineering or similar field required
  • Experience in analytical and/or polymer chemistry preferred preferred

Skills

  • Knowledge, Skills and Abilities

Compensation

  • $116,600.00 to $130,000.00
  • This position is eligible for an annual bonus in accordance with the company's bonus plan.
  • Factors which may affect starting salary include geography, skills, education, experience, and other qualifications of the successful candidate.
  • For fully remote positions, compensation will comply with all applicable federal, state, and local wage laws, including minimum wage requirements, based on the employee's primary work location.

Benefits

  • This position is eligible for an annual bonus in accordance with the company's bonus plan.
  • Plan, manage, and perform biological risk assessments of manufacturing, supplier, and material changes to medical devices and new products with patient contacting components.
  • Details of ZOLL's comprehensive benefits plans can be found at www.zollbenefits.com.

Company info

  • 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.

Equal opportunity

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

Visa & Work Authorization

  • ZOLL Medical does not provide immigration-related sponsorship for this role.
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This listing is sourced directly from Zollmedicalcorp's careers page and normalized into a canonical job model.