Fresenius Medical Care is looking for an experienced biocompatibility, sterilization, and microbiological safety professional as part of the R&D Team to develop and enhance best-in-class home and critical care products. You’ll be joining a talented team of motivated professionals at a global medical device designer and manufacturer, dedicated to improving patient experience and supporting continued business growth and expansion initiatives. This is an opportunity to use your background and experience to leave a lasting mark on a fast-paced, growth-oriented, organization. Candidates must be committed to excellence in all areas and take pride in providing elegant and scalable solutions to complex problems.
ESSENTIAL DUTIES & RESONSIBILITIES:
Responsible for supporting product development programs as well as manufacturing sites as biocompatibility, sterilization and microbiology subject matter expert (SME) in accordance with all applicable standards and regulations. This person will:
- Assess and develop test strategies to address potential impact to biocompatibility, sterilization or microbiology resulting from changes to existing devices, in collaboration with product development, quality and manufacturing teams.
- Work with cross functional teams to define and execute material safety evaluation strategies to support new product introduction (domestic and OUS).
- Write technical assessments, test protocols and test reports to support material safety.
- Coordinate the execution of test strategies, including selection of the test laboratories, review test protocol proposal, sample submission, data review, purchase requisition, and risk assessment review.
- Interface with toxicologists to define toxicological evaluation strategy and review toxicological assessments.
- Keep teams abreast of test progress.
- Work with the regulatory team in the preparation and review of technical evidence to support regulatory submissions or pre-subs and provides technical support to address questions resulting from regulatory review.
- Conduct documented assessments for the purpose of adopting or validating new or modified devices for processing in existing radiation or ethylene oxide sterilization processes according to applicable ISO requirements.
- Monitor and/or participates in Industry Standards development and revision.
- Provide support as subject matter expert during quality management system audits in the areas of sterilization, microbiology, biocompatibility and/or environmental control.
- Lead or support investigations, corrective actions and preventative actions of non-conforming events related to sterilization, biocompatibility, microbiology and/or environmental controls to ensure timely and effective resolution.
- Participate in the identification, selection and maintenance of contract sterilization facilities, test laboratories and external subject matter experts.
- Other duties as assigned
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
- Experience in the application of regulatory requirements for biocompatibility (ISO 10993, FDA, EU MDR, GLP, GMP, ISO 17025, etc)
- Experience in the application of sterilization requirements (e.g., ISO 11135, ISO 11137, ISO 17665)
- Functional expert in the principles of Sterilization, Microbiology, Biocompatibility and Environmental Control.
- Experience in the preparation of toxicological risk assessments
- Demonstrates knowledge and understanding of problem solving and regulatory requirements for the position
- Effectively balances multiple priorities and project deliverables
- Excellent writing and communication skills.
- Ability to accurately scope projects and consider the full impact of decisions and actions taken.
- Ability to establish and maintain effective working relationships with coworkers, managers and cross functional teams.
- Experience working with test laboratories and external consultants to support the biocompatibility safety program
- Proficient in Microsoft suite of applications
- Basic understanding of statistical analysis and the ability to interpret results
- Experience with externally communicating, circulating blood disposable medical devices is preferred
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
- Bachelor's degree in: Microbiology, Chemistry, Biochemistry, Biology or related field
- Minimum of 7 to 10 years of related industry experience. Advanced degree preferred.
- Potential for travel up to 20% of the time.
EO/AA Employer: Minorities/Females/Veterans/Disability/Sexual Orientation/Gender Identity
Fresenius Medical Care North America maintains a drug-free workplace in accordance with applicable federal and state laws.
EO/AA Employer: Minorities/Females/Veterans/Disability/Sexual Orientation/Gender Identity
Fresenius Medical Care North America maintains a drug-free workplace in accordance with applicable federal and state laws.