Philips Biosafety Engineer m/f/d 

Germany, Baden-Württemberg 

223632632

Biosafety Engineer (m/f/d)

You are responsible for

• Support the biosafety and reprocessing compatibility & efficacy verification & validation of the HPM product portfolio.

• Plan and manage the impact assessment of manufacturing, supplier and material changes to our patient monitoring medical devices and accessories, as well as new product developments, to ensure biosafety and product sustainability.

• Develop and maintain procedures for the biosafety evaluation of our medical devices according to the ISO 10993 and ISO 17664 series.

• Be an integral part of cross-functional teams to provide reprocessing and biocompatibility assessments, strategies, and deliverables in compliance with global regulatory requirements.

• Educate internal colleagues across departments and divisions on reprocessing and biosafety evaluations, and risk assessments.

• Collaborate and clearly communicate with internal and external stakeholders to ensure appropriate planning and execution of biological safety risk assessments and required testing.

You're the right fit if:

• You have a minimum of a Bachelor’s degree in Material Science, Toxicology, Chemical Engineering, Biomedical Engineering (Required) with an emphasis on biomaterials, polymers and organic chemistry (Desired); Master’s or PhD degree is preferred.

• You’ve acquired a minimum of 3 years’ experience in Biological Risk Assessments, with proven experience in biological test methods/strategies for compliance to ISO 10993 (required) and ISO 18562 (desired).

• You’ve acquired a minimum of 2 years’ experience in reprocessing verification & validation, with proven experience in material/chemical compatibility and microbiological test methods/strategies for compliance to ISO 17664 (required).

• You have a strong understanding of global medical device regulations/requirements/standards and experience working with outside test labs to generate test plans/evaluate results for compliance with pertinent standards; Specifically, in depth understanding of biocompatibility and reprocessing standards (ISO 10993, ISO 17664, AAMI TIR12, and ST98) as well as of relevant sections of REACH, EU MDR and Proposition 65 (Hazardous Substances Regulations) as well as ICH M7 and US FDA’s Use of ISO 10993-1 guidance documents.

• You can provide effective project management and communication skills in a dynamic, matrixed, geographically diverse business environment to meet deadlines and deliver on commitments.

• You are effective at accurately scoping projects, considering the full impact of decisions and actions taken, and balancing multiple priorities and project deliverables.

• You are proficient in statistics and Microsoft suite of office applications.

• You have strong verbal and written communication skills in English with the ability to communicate effectively at multiple levels of the organization.

We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help the lives of others.
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