Job Title
Biosafety Engineer (m/f/d)
Job Description
You are a part of
the newly formed global Biosafety and CDE team that belongs to the global Hardware Test Engineering organization within the Hospital Patient Monitoring business. You have a direct reporting line to the Biosafety and CDE Leader located in the US. The location of the job is Philips Böblingen

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.

In this role, you have the opportunity to
play an important role in improving and saving lives around the world by defining and implementing methodologies to ensure that Philips’ hospital patient monitoring products are biocompatible and safe for use by the intended patient population throughout their intended lifetime.

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.

LI-EU

About Philips

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If you’re interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our commitment to diversity and inclusion
here

• 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