Senior Biological Safety Engineer
Location
Pune | India
Job description
Job Title
Senior Biological Safety Engineer
Job Description
Exciting opportunity to play an important role in improving and saving lives around the world through generating Biological Risk Assessments and Testing strategies for Philips Sleep & Respiratory Care devices/products, ensuring they are safe for use by the patient population.
Your role:
- Responsible for preparation and documentation of Biological Risk Assessments, Testing Strategies and Dossiers for Sleep & Respiratory Care medical devices. Will also manage testing with outside test labs and analyze result from CROs.
- Learn from/adhere to internal quality manual and maintain/update current biocompatibility Quality System Procedures, Work Instructions, and Forms. Develop and conduct biocompatibility training programs, provide weekly project status reports and assist development teams in selecting proper materials for use in medical devices.
- Reporting to the Manager-Biological Safety Engineering, you will work cross-functionally and collaborate with R&D, NPD, CRO's, Regulatory Agencies internal/external scientists and other stake holders.
- This role may require travel up to 10%.
You're the right fit if:
- You've acquired a minimum of 8+ years' experience in Biological Risk Assessments, with proven experience in Biological Test methods/strategies for compliance to ISO 10993 (required) and ISO 18562 (desired).
- Your skills include conducting/documenting Biological Risk Assessments, documenting test evidence to support regulatory agency submittals, as well as interaction with Regulatory Agencies to address test strategies and questions related to Biological Rick assessments.
- You have a minimum of a Bachelor's degree in Material Science, Toxicology, Chemical Engineering, with an emphasis on biomaterials, polymers and organic chemistry. Knowledge of FDA 2020 Guidance Document 'Use of International Standard ISO 10993-1'.
- 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 to biological standards.
- You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this .
Behaviors: The successful candidate will demonstrate the following:
- Leadership: The ability to make things happen by encouraging and channeling the contributions of others recognizing and addressing critical 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 - be a mentor to junior engineers
- Influence : The demonstrated ability to gain acceptance and commitment from others to one's own beliefs and ideas.
- Negotiating: The ability to construct and maintain a strong bargaining position to ensure 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.
- Relentless focus on Quality and Transparency as an organizational value.
- In return, we offer you
Describe in two to three lines what tangible and intangible benefits the incumbent will gain in this role. Use our Employer Value Proposition (EVP) themes and information gathered in the RSM as input sources. - 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:
There's a certain energy when everyone's in the same room that can heighten idea generation and creative friction needed for problem-solving.
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.
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.
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