Post Market Surveillance Specialist jobs at Philips in Netherlands

Your role:

• Provides expert guidance to customers on complex clinical procedures and protocols, leveraging deep knowledge and experience to optimize the performance and utilization of equipment.
• Takes a proactive approach in managing customer escalations, complaints, and feedback, independently assessing situations and implementing effective strategies to address concerns and maintain customer satisfaction.
• Applies specialized knowledge in breadth and/or depth to a variety of issues and projects within the team, ensuring effective solutions and innovative approaches to complex challenges.
• Works under limited supervision and broad guidelines, regularly applying independent judgment on matters of significance to drive project success and compliance.
• Collaborates across multidisciplinary teams, including product development, research and development, and regulatory affairs, to drive innovation and improve product performance based on customer insights.
• Leads initiatives to enhance the organization's clinical support capabilities, including the development of new training materials, processes, and tools, to ensure continuous improvement and excellence in customer service delivery.
• Undertakes complex clinical or system application assignments, exercising autonomy and discretion in decision-making, and adapting to evolving circumstances to achieve desired outcomes.
• Takes ownership of documenting and maintaining service records with meticulous attention to detail, ensuring accuracy and completeness within the Service Management System.
• Conducts thorough investigations into customer complaints or escalations, gathering relevant data and evidence to facilitate resolution and prevent recurrence.
• Stays updated on new product releases, software updates, and industry developments through ongoing training, self-study, and participation in education programs and industry events.
• Develops and maintains strong relationships with healthcare professionals by actively participating in discussions, providing ongoing support, and soliciting feedback, ensuring that their concerns are effectively addressed.

You are fit if:

• Hold a Bachelor’s or master’s degree in engineering , Medical, Science, or a related field.
• Have 2+ years of experience in the medical industry, clinical support, healthcare, or customer service.
• Demonstrate deep clinical expertise and confidently guide customers on complex procedures and equipment usage.
• Proactively resolve escalations and complaints, ensuring high customer satisfaction.
• Apply specialized knowledge to solve complex challenges and drive innovation.
• Work independently, exercising sound judgement under broad guidelines.
• Collaborate effectively across functions like R&D, product development, and regulatory affairs.
• Lead initiatives to enhance clinical support through training tools and process improvements.
• Manage complex clinical or system assignments with autonomy and adaptability.
• Maintain accurate service documentation with meticulous attention to detail.
• Investigate customer issues thoroughly to drive resolution and prevent recurrence.
• Stay current with product updates, software releases, and industry trends.
• Build strong relationships with healthcare professionals, actively listening and responding to their needs.

Onsite roles require full-time presence in the company’s facilities.

This role is an office-based role.

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Your role:

• You are part of The Cardiology Informatics Clinical Excellence team. The Cardiology Informatics team in Eindhoven (within the Philips' Enterprise Informatics business group), a leader in cardiology informatics solutions with over 5000 customers globally. You will work closely with global ISCV customers and clinical application specialists, and the Cardiology Informatics R&D teams located in Eindhoven (Netherlands), Bangalore (India) and Blumenau (Brazil).
• Serve as a Clinical Application Specialist collaborating closely with global ISCV R&D development teams.
• Define clinical requirements and provide support to R&D, focusing on refining clinical features, prioritizing customer feedback, validating products, leading clinical testing, assessing risks, and understanding regulatory factors.
• Translate clinical requirements from customers, product management, and marketing to engineering teams for efficient development and verification processes.
• Conduct training sessions for field clinical application specialists and customers on new clinical features and products, while keeping abreast of the latest innovations in cardiology imaging.
• You'll build and maintain strong relationships with validation and collaboration sites.
• Discover the many benefits of a career at Philips. Speak with your recruiter to learn more about the benefits available in your region.

You're the right fit if:

• You hold a Bachelor's or Master’s degree in Ultrasound.
• You have 3+years of sonography experience, knowledge in usage of ultrasound and product features within the cardiology domain.
• You can understand, convey, and teach others the clinical workflows in cardiology specialties and technical use of the specific solutions.
• You have high energy, and self-driven mentality.
• You have an affinity with IT Solutions, you will be able to liaison between clinical and technical conversations.
• You are highly flexible and motivated team player, who can establish relationships with both internal and external customers.
• You are familiar with Philips products, such as IntelliSpace Cardiovascular, Xcelera, XperIM or Philips Ultrasound.
• You have excellent customer-centric & communication skills.
• You are fluent in Dutch and have a good command of English in written word and speech
• You are willing to travel up to 15% of your time and are able to travel globally on a short notice to meet with our customers.

This role 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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Your role:

• Investigates and resolves complaints by monitoring product analysis findings, documents underlying issues, and ensures the implementation of solutions.
• Works with limited supervision and broad guidelines.
• Support the end-to-end investigation of complaints, analysing findings, and presenting a concise overview of the inquiry process.
• Escalates complex matters to appropriate channels for further assistance and resolution.
• Supports technical complaint investigators from other disciplines, provides guidance, and hands-on instruction to facilitate their understanding of complaint handling processes, regulatory requirements, and best practices.
• Cultivates strong relationships with complaint investigators and other internal stakeholders, ensuring effective resolution of post-market issues and continual improvement in product quality and safety.
• Prepares and presents regular management reports on improvement initiatives outcomes, trends, and areas of concern to management.
• Supports stakeholders during the execution of quality system- and product audits and inspections.

You're the right fit if:(4 x bullets max)

• You have a technical master’s or bachelor’s degree in electronics, electrical engineering, mechanical engineering, mechatronics, or equivalent.
• You have at least 1-3 years work experience in multidisciplinary teams. Preferably in a quality, Post Market Surveillance, and/or product development environment.
• You take ownership of complaints and to work with cross-functional teams to close them.
• You have affinity and/or experience with Post Market Surveillance and/or Complaint handling processes
• You have affinity and/or experience with medical device regulations and standards. E.g., 21 CFR part 820, MDR, ISO 13485, IEC60601-01
• You have good communication and influencing skills in English and preferable a basic knowledge of the Dutch- and German Language.
• We believe that we are better together than apart. This means working in-office at least 3 days per week.

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 the lives of others.
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If you’re interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our culture of impact with care .

Your role:

• Manage all Post Market Surveillance activities for the Grooming & Beauty medical devices (e.g. IPL devices).
• Serves as the primary liaison for internal and external stakeholders, handles all aspects of complaint investigations and resolutions, coordinates communication between stakeholders and ensures timely and effective resolution of issues.
• Stay up to date with medical device regulations and standards (e.g., 21 CFR part 820, MDR, ISO 13485, IEC60601-01) in relation to Post Market Surveillance.
• Works with limited supervision and broad guidelines.
• Enforces standards for appropriate coding to records as input for the complaints process, ensures all systems and tools are updated, and reviews and updates complaints as new codes become available.
• Supports Complaint handlers with customer response letters (CRL) or internal responses, as appropriate, upon concluding the investigation, and escalates complex matters to appropriate channels for further assistance and resolution.
• Heads the end-to-end investigation of complaints, analysing findings, and presenting a concise overview of the inquiry process.
• Escalates complex matters to senior stakeholders for further assistance and resolution.
• Cultivates strong relationships with internal and external stakeholders, ensuring effective resolution of post-market issues and continual improvement in product quality and safety.
• Prepares and presents regular management reports on improvement initiatives outcomes, trends, and areas of concern to management.
• Supports stakeholders during the execution of quality system- and product audits and inspections.

You're the right fit if:

• You have a master’s or bachelor’s degree in medical sciences, healthcare management, industrial engineering, mechanical engineering, mechatronics, or equivalent.
• You have at least 3-5 years work experience in multidisciplinary teams. Preferably in a quality, Post Market Surveillance, and/or product development environment.
• You take ownership for implementation and management of requirements coming from medical device regulations and standards.
• You have affinity and/or experience with Post Market Surveillance and/or Complaint handling processes.
• You have strong affinity and/or experience with medical device regulations and standards (e.g., 21 CFR part 820, MDR, ISO 13485, IEC60601-01).
• You have good communication and influencing skills in English and preferable a basic knowledge of the Dutch Language.
• We believe that we are better together than apart. This means working in-office at least 3 days per week.

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 the lives of others.
• Learn more about .
• Discover .
• Learn more about .
If you’re interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our culture of impact with care .

You are responsible for

• Participating as the PMS representative in the preparation, authoring (when applicable) review and approval of Post Market Risk Assessments and Health Hazard Evaluations.
• Collaborating with key stakeholders required for the execution of Post Market Risk Assessments such as Development, Risk Management and Medical Affairs.
• Supporting consistency of decisions of Health Hazard Evaluation, Product Hold and Field Safety Corrective Actions.
• Managing the Product Hold process for IGT-Systems (Fixed System) for products manufactured in Best (Netherlands).
• Managing the collection of the information required for the Hold determination and the facilitation of Product Hold initiation meetings.
• Being a back up for the creation of documentation required by the Product Hold process (e.g. Hold initiation form, Communication form, UAL and Hold closure forms).
• Supporting the identification and maintenance of appropriate metrics on the efficacy and efficiency of the Post Market risk assessment and Product Hold activities and monitoring and reporting on those metrics.

You are a part of

You will be part of the Post Market Surveillance Team, a young, dynamic and multicultural team.

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

• Bachelor’s degree in biomedical engineering, science, healthcare, or medical profession.
• 5 years’ experience in Quality in Medical Device and/or other regulated industry preferably in Risk Management, Design Quality or Correction and Removal/Recalls or product development.
• Focus on detail.
• Good analytical skills and process improvement capabilities
• Teamwork in and outside Quality.
• Strong written and oral communications skills in English and demonstrated ability to effectively communicate technical content to a variety of internal and external audiences (e.g. Authorities, customers).
• High degree of initiative, engagement, self-motivation and flexibility.
• Able to work in a changing environment and be a driver of change.
• Product Knowledge is preferred.

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Senior Technical Complaint Investigation Specialist

You will become part of the Complaint Handling team of the Image Guided Therapy Systems Quality organization, which is responsible for ensuring patient safety and quality, customer satisfaction, and regulatory compliance through the complaint-handling process. Your role will be key in ensuring that complaints are investigated with high quality, leading to safe and effective products and satisfied customers. You will help lead and steer a global cross-functional team as a liaison and subject matter expert.

Your role:

• Focus on developing long term strategy for timely and appropriate action on the technical investigations of High-Risk complaints: ensuring correct identification, preparing complaint technical and part investigation strategy, reviewing complaint investigation, vigilance reporting and supporting further QMS activities such as Product Defects, Supplier Quality, CAPA intake and Corrections and Removals (C&R).

• Creates and deploys technical investigation guidelines for malfunctions and new reportable C&Rs. Support creating bi-directional traceability from complaints to CAPA’s.

• Identify groups of complaints relating to similar failures and what is needed from R&D to perform a complete technical investigation

• Technical investigations for Customer feedback and for Customer letters

• Failed Parts return process: Quality review of parts reports

• Support usage of AI and/or Large Language Models (LLM’s) and tooling in order to improve complaint investigation

• Setting strategy and proposing solutions such as tooling, automation and simplification of complaint technical investigation through the use of AI & LLM’s.

• Accountable for representing the Business in complaint handling deliverables by acting as a liaison between the business, market, and Shared Service.

• Acts as a Liaison with product experts within the business (R&D, Clinical, Manufacturing, sustaining) to address product specific issues related to customer complaints, to ensure robust complaint investigations are conducted.

• Supports Quality management System activities related to complaint handling and complaint data for CAPA, Corrections and Removals (C&R), training management review and internal and external audits.

• Analysis complaint data gathers additional data as needed, and partners cross functionally to provide feedback to the BIU supporting complaint evaluation and/or to the Post Market Surveillance management on potential process and quality improvements

• Assess critical events and elevate and engage appropriate management when required

• Escalate to the Complaint Handling Business Lead when necessary to determine the action to drive timely and effective resolution of the complaint.

• Develop and implement training materials and train associates on all procedures, policies and guidelines

You're the right fit if you have:

• Bachelor’s or higher degree preferably in Engineering or Science.

• Over 7 years of relevant experience as a Senior SME or Lead within the medical device or regulated industry, specializing in either Quality or R&D domain:

  • Quality functions such as complaint handling, adverse event reporting and related processes.

  • R&D functions with a high involvement and interest in product quality improvements.

• Experience leading improvement programs and/or leading teams and projects.

• Strong product improvement drive and passion for Customer satisfaction, Patient Safety and Quality applied to daily work.

• Good analytical skills and process improvement capabilities with the ability to resolve complex issues in creative and effective ways.

• Strong regulatory writing and audit communication skills.

• High engagement, motivation, and flexibility.

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Your role:

• Driving overall business by providing clinical and technical product (modality) expertise on the Enterprise wide product / modality across the accounts.

• Working directly with customers promoting Options, add-ons & upgrades to convert opportunities to sales for growing CLV revenue.

• Lifecycle business across Equipment and Service and enterprise wide (all modalities / businesses).

• Building a network of key contacts (Sponsor & Power Sponsor – Decision Maker) and relationships within accounts to convert opportunities to sales supporting the customer buying journey.

• Creating proactive touchpoints to customers, utilizing multiple channels such as social media, e-com, try & buy activations (especially on MR) and virtual meetings. Contact customers via telephone and/or email to new and/or competition accounts as well as be responsible for the timely response to converting leads to order by developing opportunities.

• If / when support needed team up with appropriate sales team members on qualified and matured opportunities for closure.

• Researching accounts to understand customer pains, using data analytics internal and external, identifying key players and generating interest, as well as investigation & resolve customer queries/requests.

• Contacting prospective customers, in follow-up to marketing campaigns (events, tradeshows, demand generation through the web etc.) to close qualified sales opportunities.

• Managing portfolio by setting objectives for each call to maximize territory business plans. Supports the Account managers and District Managers in achievement of business goals including balanced selling and BG/BIU AOP attainment and validating product forecasts.

• Performing effective online demos to prospects using web based virtual software.

You're the right fit if:

• Bachelor’s degree with proven experience in medical imaging (MRI) and preferably clinical sales.

• Proven experience in SaaS (Software as a Service) is an asset.

• Strong listening, presentation, communication and negotiation skills.

• Proven ability to work effectively within a team-selling environment.

• Self-driving team player; Frequently interacts with doctors and clinical physicists at our customers.

• Able to think and act cross boundaries and work in virtual multidisciplinary teams.

• Able to work independently and provides consultative advice within specific functional areas.

• Customer oriented and stress resistant.

• Fluent in Dutch and English, both verbal and written. Knowledge of French is an asset.

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 the lives of others.
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