Biological Safety Engineer hos Philips


JOB DESCRIPTION

Job Title

Biological Safety Engineer

Job Description

Philips is a global leader in health technology, committed to improving billions of lives worldwide and striving to make the world healthier and more sustainable through innovation. Driven by the vision of a better tomorrow.
But it’s not just what we do, it’s who we are. We are 80,000, wonderfully unique individuals, with two things in common. and a relentless determination to deliver on our customers’ needs. It’s what inspires us to create meaningful solutions – the kind that make a real difference – when it matters most.
The world and our customers’ needs are changing faster than ever before and while we are proud of what we do already, we know we can do more. That’s why we need you, to help us tackle increasingly complex challenges posed by ever evolving health and well-being needs.
In this role, you have the opportunity to be part of Philips Sleep and Respiratory Care as a Biological Safety Engineer focused on Ventilation & related accessory products. You will be responsible for implementing technical strategies, evaluating, and developing products, and providing a superior level of technical support that benefits the organization. The position collaborates closely with Mechanical Engineers, Clinical Affairs, Marketing, Quality & Regulatory in the Ventilation business 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 are responsible for

  • Formulates and executes on biocompatibility and cleaning test plans, protocols, and reports.
  • Establish 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.
  • Manage and maintain vendors including supporting audits of the contract facility.
  • Author and review validations and product adoptions into existing cycles.
  • Perform testing and maintains documentation to support the use facility of single use and reusable products supporting ventilation.
  • Encourage continuous process improvements environment.
  • Additional responsibilities may be assigned, as required, by management.

In addition,
  • Work with a team to assess products for compliance to international biological standards.
  • Document biological test strategies and manage testing with outside test labs.
  • Document biological risk assessments and analyze result from CROs.
  • Learn from and adhere to internal quality manual (Quality System Procedures, Work Instructions, Forms).
  • Maintain and update current biocompatibility Quality System Procedures, Work Instructions, and Forms.
  • Develop and conduct biocompatibility training programs.
  • Provide weekly project status reports.
  • Prioritize project tasks to complete on schedule while maintaining quality of work.
  • Work in a team environment; peer review work.
  • Work on multiple, concurrent project

You are a part of Connected Care cluster organization focusing on development of mechanical and electrical designs for a common platform serving multiple product lines. Healthcare Innovation Center (HIC) is playing a key role in Philips global strategy for Connected Care businesses.
At Philips we are passionate about improving quality of life with solutions designed around the needs of customers and their patients. Innovation is driven by gaining insight to the needs of the people who use our sleep and respiratory solutions. This tradition of innovation, combined with our ability to anticipate market needs, has made Philips a global leader in the markets we serve.
To succeed in this role, you’ll need a customer-first attitude and the following
  • Bachelors or Master’s Degree in Material Science, Toxicology, Chemical Engineering with emphasis on biomaterials, polymers and organic chemistry.
  • Minimum of 5+ year’s professional experience
  • Lab management experience preferred
  • Knowledge of biological test methods for compliance to ISO 10993 and ISO 18562 (desired).
  • Familiarity with FDA 2016 Guidance Document “Use of International Standard ISO 10993-1.”
  • Experience conducting biological assessments of medical devices.
  • Experience documenting biological test evidence to support FDA submittals.
  • Experience working with outside test labs to generate test plans and evaluate results for compliance to biological standards.
  • Understanding of global medical device regulations, requirements, and standards.

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.

In return, we offer you a challenging, innovative environment with great opportunities to explore. Our benefits are very competitive and designed around your preferences:
  • A rewarding career in Philips with attractive package.
  • A variable bonus based on both Philips results and personal performance
  • Extensive set of tools to drive your career, such as a personal development budget, free training and coaching
  • Attractive collective health insurance package
  • Opportunity to buy Philips shares and products with discount

How we work at Philips

Our newly-adopted hybrid work concept fuses flexibility with collaboration to deliver great outcomes for our people and our customers. We are embracing an approach wherein we spend more time together than apart – which for full-time employees translates to an average of at least 3 days working from the office and up to 2 days from home – for our hybrid roles.
Hybrid work flexibility means people can meet the changing demands of work and home in the most balanced, productive, and healthy way.
Our hybrid working model is defined in 3 ways:
We believe in the importance of impactful collaboration: There's a certain energy when everyone’s in the same room that can heighten idea generation and creative friction needed for problem-solving.
We embrace flexibility: Choosing where, when and how to work can vary according to task and team schedules. Flexibility isn’t office or online, it means choosing the space that works best for you, your teams and our customers on a case-by-case basis.
We want to be at our best: The way we work and our workspaces are designed to support our well-being, offer career advancement opportunities, and enable us to be at our best.

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 innovative, customer-first health technology solutions. Help us improve the health and well-being of billions of people, every year. Ultimately creating a career that no one could have planned for. Even you.
To find out more about what it’s like working for Philips at a personal level, visit the on our career website, where you can read stories from our . Once there, you can also learn about our , or find answers to some of the .
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