Co-op – Ultrasound Regulatory Data Analytics jobs at Philips in United States, Bothell

Your role:

• We are looking for a detail-oriented intern with a passion for data analytics.
• Key responsibilities include analysis of datasets to identify trends and provide insights; development of dashboards and reports for stakeholders to visualize data; maintenance of accurate documentation of data findings; designing and implementing efficient data collection strategies.
• You will play a key role in analyzing datasets and extracting actionable insights that enhance our business strategies.

You're the right fit if:

• You are enrolled in a Bachelor's/Master's program in Data Analytics, Statistics, Computer Science, or related field.
• You have strong analytical skills, attention to detail, and excellent communication skills.
• Your skills include proficiency in data analytics tools like Excel, SQL, Python, R, Tableau, or Power BI.

• You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this

How we work together

This is an office role.

We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help improve the lives of others.

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The hourly pay range for this position is $28.00 to $32.00, plus overtime eligible. The actual base pay offered may vary within the posted ranges depending on multiple factors including job-related knowledge/skills, experience, business needs, geographical location, and internal equity.

Details about our benefits can be found .

US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa, now or in the future.

be provided for this position. For this position, you must reside inwithin commuting distance to Bothell, Cambridge, Plymouth

• Provides enterprise architecture guidance to IT Architects, facilitates strategic decision-making, and supports the development and implementation of cohesive architectural solutions across the enterprise.
• Spearheads the assessment of current and future capabilities, identifying opportunities for improvement and takes charge of Business Capability Analysis, ensuring that IT strategies align seamlessly with overarching business, market, and financial objectives.
• Leads enterprise architecture roadmap activities, communicates with stakeholders regarding developments and milestones, and the maintains Enterprise Architecture (EA) assets to ensure its alignment with evolving technology landscapes.
• Manages enterprise architecture risk, mitigates potential issues, and collaborates with stakeholders to maintain the integrity and security of the architecture framework across the organization.
• Facilitates enterprise architecture communication, ensures clear and effective information exchange among stakeholders, and promotes collaboration across teams to optimize resource utilization and enhance overall operational efficiency.
• Drives comprehensive enterprise-wide architecture integration acrossProduct andEnterprise IT and ensures cohesive alignment, streamlined processes, and optimal resource utilization throughout the organization's technological landscape.
• Guides and mentors other enterprise IT architects to ensure the effective execution of their work, foster skill development and adherence to organizational standards.
• Leads the delivery of the multi-year enterprise architecture roadmap by providing critical input into the yearly planning cycle, ensures resource allocation, and the seamless integration of long-term architectural goals with annual objectives.

• Bachelor's / Master's Degree in Information Technology, Computer Science, Enterprise Architecture Frameworks, Cloud Architecture, Data Architecture, Agile and DevOps Practices or equivalent.
• Minimum 8 years of experience in IT Solution Design, Business Process Management, Enterprise Architecture, Cloud Architecture or equivalent.
• TOGAF (The Open Group Architecture Framework) certification (preferred)
• Self-motivated, with an ability to work under own initiative, often under time criticalconditions
• Can-do, problem-solvingattitude
• You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this .
• Your experience includes medical device or heath technology industries, including compliance with FDA, ISO, and other regulatory requirements.
• Strong experience with digital transformation and change management initiatives.
• Proven ability to bridge the gap between business needs and technical solutions.
• Strong stakeholder engagement, communication, and presentation skills.
• You thrive in cross-functional teams and are comfortable operating within a global, matrixed organization.

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As a,,

Your role:

• Lead global product launches and drive the adoption of GI & WH products and solutions.
• Partner with regional teams to optimize Go-To-Market.
• Collaborate with upstream product management, clinical, and research teams to ensure success in the marketplace.
• Oversee product launch readiness and ensure smooth new product introductions.
• Drive demand generation through branding, campaigns, and sales enablement efforts.

You're the right fit if:

• You have a Bachelor’s Degree. MBA preferred.
• You have 5+ years of experience in marketing, or product management. Ultrasound experience required.
• Your skills include excellent communication, presentation, and interpersonal and influence skills at all levels of an organization. As well as a collaborative mindset to work cross-functionally, up and downstream, to design the successful activation plans our value propositions in the regions.
• field. Experience studying and living abroad preferred.
• You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this .
• You are an adaptable, open-minded team player with a can-do mentality, able to identify opportunities within business challenges and turn them into actionable plans that drive cross-functional team execution.

How we work together

This is an office role.

We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help improve the lives of others.

• Learn more about .
• Discover
• Learn more about
• Learn more about

The pay range for this position in Bothell, WA is $126,000 to $202,000.

US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa, now or in the future.

In late January we announced that
Bridgefield Capital

The Senior Quality Engineer-Data Analytics will create new tools and methods to analyze quality data and create meaningful recommendations that enable leadership to make better decisions that contribute to the safety and efficacy of Emergency Care products that save lives and improve health.

Your role:

• Responsible for Identifying/Using state-of-the-art business intelligence, reporting/data analysis methods, technology and tools, such as machine learning, computational statistics, and data mining to identify hidden insights from the wealth of data available within Philips.
• Will manipulate big data sets using innovative tools as well as proven techniques to disseminate complex raw information into clear and concise recommendations.
• Compile, analyze, and effectively present trending reports to identify opportunities that increase efficiency, ensure quality, and decrease cost.
• Develop and implement tools and techniques resulting in recommendations that enable leadership to make better data-based decisions.
• Build custom data queries and standardized reports by collaborating with internal customers to understand their needs.
• Compile and review Quality Operations KPI’s and support the compliance effort of the Quality & Regulatory team. Support ongoing compliance improvement initiatives, including CAPAs. Validate all standardized queries, reports, and metrics used for quality purposes.
• Leads cross function projects and demonstrates expertise in implementing strategic improvement projects. Acts in a leading position as both a technical coach and strategist for Data Analytics. Creates and continually improves procedures and work instructions to ensure reliable, repeatable results.

You're the right fit if:

• You’ve acquired a minimum of 7 years’ experience in Data Analytics, with a focus on analyzing large sets of data in Healthcare, Finance, Aerospace, or other applicable, highly regulated, industries. Experience working within a Quality Management System (QMS) required. Experience working in an FDA regulated medical product environment preferred.
• Experience implementing strategic Data Analytics initiatives across organizations and ability manage multiple large/complex projects simultaneously.
• Excellent customer service and interpersonal communication skills, including regularly leading presentations in front of leadership. Excellent teamwork skills, with proven ability to influence and build rapport with internal customers and stakeholders.
• Experience with data mining methods, statistical analysis, & data visualization methods, as well as writing queries for relational databases, such as MS SQL Server.
• Experience with tools/languages such as Power BI, Minitab, Excel, Python, etc.
• You have a minimum of a Bachelor’s Degree (Required) in Data Science/Analytics, Statistics, Computer Science, Information Technology, or a related field. MS preferred. Six Sigma Green/Black Belt certification preferred.
• You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this .

How we work together:

We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help improve the lives of others.

• Learn more about .
• Discover
• Learn more about
• Learn more about

Philips Transparency Details:

• The pay range for this position in Bothell, WA is $128,000 to $205,000.

Additional Information:

• US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa, now or in the future.
• Company relocation benefits will not be provided for this position. For this position, you must reside in or within commuting distance to Bothell, WA.
• May require travel up to 10%.

The Regulatory Affairs Program Manager will play a critical role in preparing comprehensive regulatory strategies, submissions and post market changes for Class III Defibrillators, Automated External Defibrillator’s (AED’s) and associated Software/ Software as a medical Device (SaMD).

Your role:

• Responsible for executing regulatory strategies, detailed regulatory plans and submissions for Class III Defibrillators, Automated External Defibrillator (AED), Software/ Software as a medical Device (SaMD).
• Educate and advise cross-functional teams on evolving regulatory requirements and best practices specific to SaMD, clinical evidence generation, and AI/ML-based medical devices. Provide clear and timely interpretation of global regulations that are actionable for assigned projects.
• Execute pre-market and post-market regulatory activities as per applicable procedures supporting software-enabled medical devices and Software as a medical Device (SaMD). with focus on major markets including the US, Canada and EU.
• Represent regulatory affairs in key activities including Quality Management Reviews, risk management, design reviews, portfolio selection process, change management, adoptions of new guidance / standards, post-market activities, audits, inspections.
• Provide guidance to business partners and junior regulatory staff regarding regulatory requirements including, including design control activities, indications of risk and approximate timing for approval for planning purposes. Supports both new product development and currently marketed product portfolio

You're the right fit if:

• You’ve acquired a minimum of 7 years’ experience in Regulatory Affairs within FDA regulated medical device/software (SaMD, SiMD) environments, AED’s/Defibrillators or other Class III Devices containing medical electrical equipment highly desired.
• You have expertise in software specific regulatory guidance/requirements, standards including IEC 62304), SaMD (IEC 82304), TIR45, Artificial Intelligence (AI), cybersecurity, and human factors (IEC 62366). algorithms and experience with AED’s/Defibrillators or other Class III Devices highly desired.
• You’ve acquired extensive experience and knowledge of global medical device regulations, guidance, and applicable standards including original PMA, PMA supplements, pre-submission 510K, De Novo, Technical Documentation preparation and associated guidance, standards.
• You have a proven track record of working/communicating effectively with Global cross-functional teams and with external stakeholders (e.g. Notified Bodies, FDA, Competent Authorities).
• You have In-depth knowledge of FDA regulations (ISO/IEC/CFR) related to risk management and the development of safe software products including ISO 14971, ISO 13485, 21CFR 820, EU MDR, IEC 82304, IEC 62304, and IEC 62366-1
• You have a Minimum of a Bachelor’s Degree (Required) in Regulatory Affairs, Biomedical Engineering, Clinical/Life Science or similar disciplines. Master’s Degree desired. RAC Certification desired.
• You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this .

We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help improve the lives of others.

• Learn more about .
• Discover
• Learn more about
• Learn more about

Philips Transparency Details:

• The pay range for this position in Bothell, WA is $128,000 to $205,000.

Additional Information

• US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa, now or in the future.
• Company relocation benefits will not be provided for this position. For this position, you must reside in or within commuting distance to Bothell, WA.
• May require travel up to 10%.