Biocompatibility Engineer

This position can be fully remote and work from anywhere in the US.  

In this role, you will have the opportunity to:

Be a part of Philips Hospital Respiratory Care Systems Engineering group as a Biocompatibility Engineer focused on Ventilation & related accessory products. You will be a part of the Systems Engineering group that is responsible for implementing technical strategies, evaluating and developing products, and providing a superior level of technical support that benefits the organization. 

You will be responsible for:

The position within the System Engineering group collaborates closely with Mechanical Engineers, Clinical Affairs, Marketing, Quality & Regulatory in the Ventilation business within and outside the Hospital and Respiratory Care (HRC) to develop and commercialize Class 2 medical devices. This position shall provide strategic direction related to the development of systems and programs for the following areas: Microbiology, Cleaning and Biocompatibility testing.

Essential Functions:

• Formulates and executes on biocompatibility and cleaning test plans, protocols and reports.

• Establishes effective work processes and standardized procedures that ensures compliant documentation of routine testing results and timely completion of business milestones using industry-accepted scientific principles with independent test laboratories.

• Manages and maintains vendors including supporting audits of the contract facility.

• Authors and reviews validations and product adoptions into existing cycles.

• Performs testing and maintains documentation to support the use facility of single use and reusable products supporting ventilation.

• Encourages continuous process improvements environment.

• Additional responsibilities may be assigned, as required, by management.

To succeed in this role, you should have the following skills and experience:

Education and/or Experience:

• Master’s or PhD degree in Engineering or Science discipline.

• At least three years of formal education in Microbiology.

• At least 5-7 years of experience in cleaning, sterilization and biocompatibility in a medical device setting.

• In-depth knowledge of quality assurance techniques, practices, ISO and Regulatory (FDA) compliance.

• In-depth knowledge of medical device regulations and standards – example 18562 and 10993 standards.

• Understanding of ventilation is a plus.

Competencies:

• Ability to work with teammates in accordance with company objectives.

• Ability to define problems, collect and analyze data, establish facts, and draw valid conclusions.

• Ability to verbally communicate ideas and issues effectively to other team members and management.

• Actively network with the internal and external scientific, technical and regulatory community to maintain state of the art knowledge.

• Partner with Quality to support the development, maintenance and adherence to quality systems and continuous process improvement.

• Partner with research, product development and regulatory affairs functions to ensure new and sustaining products meet all necessary requirements.

Soft Skills:

• Leadership: The ability to make things happen by encouraging and channeling the contributions of others; recognizing and addressing important issues in a timely manner, and acting as an agent for change and continual improvement when required to achieve results.

• Accountability/Ownership: Work closely with team members and take ownership – educate and communicate to the team

• Influence: The demonstrated ability to gain acceptance and commitment from other to one’s own beliefs and ideas.

• Negotiating: The ability to construct and maintain a strong bargaining position so as to insure positive response and agreement: striving for win-win situations.

• Adaptability: Must possess the ability to understand new concepts quickly and apply them accurately throughout an evolving environment and organize work assignments to meet established timetables.

• Data-Driven Decision Making: ability to move teams through vague and complex situations. Present complex ideas in a simple manner to resolve issues.

You will be a part of:

You are empowered to use your voice and expertise to have a positive impact on your team, the business, and health technologies that will improve the health, well-being and care for people around world.  You will be part of the Hospital Respiratory Care Systems Engineering group. 

In return, we offer you:

Philips welcomes you to a challenging, innovative environment with great opportunities for you to explore and grow.

Quality is on the top of Philips leadership agenda and that means you have the unique opportunity to come in and have a recognized voice to drive and witness exciting, transformational changes. You will be empowered to drive high quality, groundbreaking innovations with a globally recognized, premium brand behind you. And when you are successful in this role you will have an array of diverse career opportunities open to you – across different functional areas, product lines, business groups and/or geographies. That is a commitment Philips Quality Leadership team has made and stands by.

Why work on a project at Philips?

If you’re looking for meaningful work and a chance to tackle complex challenges, broaden your skills and expertise and become an even more sought after professional, you’ll find all that and more with project work at Philips.

The Randstad companies are responsible for finding talent to provide services at Philips. If you are selected to provide services for Philips, you will be employed by Randstad and will not be an employee of Philips.