In this role you have the ability 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. 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.
You will be responsible for
- 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 (preferred) degree in Engineering or Science discipline.
- At least three years of formal education in Microbiology.
- At least 5 or more 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.
- 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.
- 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.
Why should you join Philips?
Working at Philips is more than a job. It’s a calling to create a healthier society through meaningful work, focused on improving 3 billion lives a year by delivering innovative solutions across the health continuum. Our people experience a variety of unexpected moments when their lives and careers come together in meaningful ways. Learn more by watching this video.
To find out more about what it’s like working for Philips at a personal level, visit the Working at Philips page on our career website, where you can read stories from our employee blog. Once there, you can also learn about our recruitment process, or find answers to some of the frequently asked questions.
It is the policy of Philips to provide equal employment and advancement opportunities to all colleagues and applicants for employment without regard to age, color, citizenship, disability or perceived disability, ethnicity, gender, gender identity or expression, genetic information, marital or domestic partner status, military or veteran status, national origin, pregnancy/childbirth, race, religion, sexual orientation, or any other category protected by federal, state and/or local laws. Philips is an equal employment opportunity and affirmative action employer Disability/Veteran.
As an equal opportunity employer, Philips is committed to a diverse workforce. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants that require accommodation in the job application process may contact 888-367-7223, option 5, for assistance.
If you forgot your password, you can click the Forgot Password button on the Sign In screen to reset it. In case of technical difficulties, please send an email to email@example.com.
(Note: To ensure fairness and legal compliance in our recruitment processes, only technical issues will be monitored through the above inbox. Please do not submit resumes or applications to this email, as they will not be reviewed. Only applications received through the online application process will be considered.)