דרושים Process Engineer - Npi & Sustaining ב-Philips ב-United Kingdom, Rushmoor

Your role:

• Join our team as a Quality Engineer to play a key role in our Product Safety, property and environmental risk management, contributing to the safety & efficacy of medical products that save lives and improve health.

• You will collate post market information, analyse, and then facilitate the decisions needed to manage risk and ensure product safety, including the management of Issue Impact Assessments and Risk Files.

• Working in partnership with Complaints, Post Market Surveillance, R&D, Clinical, Regulatory and Corrections & Removals.

• Be sure to ask your recruiter to share information on the compensation package

How we work together

• We believe that we are better together than apart. For our office-based teams, this means working in-person at least 3 days per week.

• This role is based from our Farnborough, Hampshire office.

You’re right for this role if:

• You have experience in the Risk Management Process in a

  regulated environment
  and have worked hands-on with
  ISO 14971
  standard.

• You have a good understanding of

  risk management
  requirements, tools, methodologies, and processes, including use of a variety of accepted methods.

• You describe yourself as organised and methodical, comfortable with working in the detail of a Quality Management Systems and regulatory requirements.

• You are comfortable analysing post market data to detect patterns, support decisions and produce reports for leadership teams.

• You bring with excellent teamwork skills able to influence and build rapport with internal customers and stakeholders.

Your role:

• Coordinating technical capability assessments of potential new suppliers, ensuring they meet stringent quality standards, monitoring supplier performance, reporting, and improvement, and coordinates the supplier selection.

• Overseeing conduction of DFMAT (Design for Manufacturing and Assembly Technique), SAF (Supplier Approval Form), MSA (Measurement System Analysis), PFMEA (Process Failure Mode and Effects Analysis), Control Plan, SPC (Statistical Process Control), PV&V (Process Validation and Verification), FAI (First Article Inspection), LRA (Logistics Risk Assessment), and SICR (Supplier Initiated Change Request).

• Managing, developing, monitoring, and controlling APQP (Advanced Product Quality Planning) plans as part of the NPI process to ensure consistent quality and compliance as well as facilitating supplier improvement initiatives.

• Sustains Design for Excellence (DfX) collaboration between R&D and suppliers, promoting innovation and high-quality product design.

• Ensures Critical to Quality (CtQ) characteristics are effectively communicated to suppliers and rigorously maintained throughout the production process.

• Negotiating Supplier Quality Agreements, performing defect analysis to determine supplier responsibility, and acting as an independent reviewer for Supplier Corrective Action Requests.

• Be sure to speak to your recruiter about all the benefits on offer.

How we work together

• We believe that we are better together than apart. For this role, this means working in-person at least 3 days per week at our Farnborough, Hampshire office.

You’re right for this role if you have:

• A Bachelor's/ Master's Degree in Engineering Science, Supply Chain Management, Electrical Engineering, Electronic Engineering or equivalent.

• Relevant experience in areas such as Quality Engineering, Safety Engineering, Process Engineering, Continuous Improvement Techniques or equivalent, gained ideally within the Medical Device industry, but if not a similar regulated sector (Aerospace, Pharmaceutical, Defence, Automotive).

• Managed Supplier Quality Management within a contract manufacturer

• Knowledge of Quality Management Procedures and Methodologies including CAPA, SCAR etc

For more information, read our Inclusion and Diversity Policy and, to know more about your Human Rights, we encourage you to view this .

Your role:

• Receives, analyzes, and processes incoming ECG transmissions using Independent Diagnostic Testing Facility (IDTF) software, ensuring accurate technical evaluation and timely completion of event processing.

• Reviews ECG recordings for rhythm interpretation, accurately identifying normal and abnormal patterns and ensuring all findings are thoroughly documented for clinical review.

• Handles escalated ECG cases from lower-level technicians by analyzing complex heart rhythms and ensuring accurate interpretation and timely response. Maintains high standards in clinical assessment to support consistent and reliable reporting.

• Conducts thorough quality assurance reviews of all processed ECG data to ensure accuracy and compliance with reporting standards. Assists with IDTF software and equipment maintenance, promptly reporting technical issues to minimize workflow disruptions.

• Contribute to the success of the Clinical Wireless Monitoring department by consistently meeting or exceeding performance standards and key productivity indicators. Maintain a high level of accuracy and quality while completing responsibilities on time in a collaborative, team-based environment.

Availability/shift requirements:

• As a 24/7/365 operation, open availability is required, including rotating days, evenings, overnights, weekends, and holidays. While preferred shifts will be taken into consideration, final scheduling is based on business needs and cannot be guaranteed.

The current shift schedules are as follows:

• 1:00pm-11:30pm PST

• 9:00pm-7:30am PST

You're the right fit if:

• You have a High School Diploma or Vocational Education; an active CRAT or CCT certification, RN license, or licensed Paramedic with current ACLS certification.

• You’ve acquired 1+ years of experience as a Clinical Wireless Monitoring Technician I or 1+ years’ experience in a clinical setting involving ECG/EKG monitoring and/or interpretation and analysis experience.

• Your skills include strong proficiency in Microsoft Office applications, strong technical acumen, and excellent computer skills, along with the ability to efficiently navigate multiple technical platforms simultaneously while adapting to change with ease and possess strong ECG rhythm interpretation.

• 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 excellent communicator with meticulous attention to detail, a collaborative mindset, and the ability to thrive in a dynamic, fast-paced environment.

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 pay range for this position in Pleasanton, CA is $24.00 to $38.00

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.

Your role:

• Supporting hardware development projects with electronics design in a ISO 13485 / FDA 21 CFR Part 820 quality system. These will either be developing new or refining and enhancing existing features.

• Supporting the team during External system testing, investigating, and resolving issues and formally reporting test results.

• According to the V-Model for system development you will write design specifications, specify components, create schematics evaluating designs and prototype testing.

• Working in close collaboration with suppliers to manufacture prototypes, pre-production units to your designs and into full subcontractor production.

• This role offers you chance for hybrid working from our vibrant & exciting new offices in Farnborough, Hampshire. Additionally, we are open to discuss flexible working requirements to better support your work life balance.

• From competitive salary and yearly performance bonus. Be sure to speak to your recruiter about all the benefits on offer.

You’re right for this role if:

• You career has been in Electrical Engineering (both sustaining and new products).

• You have worked in the Medical Device industry or a similar regulated environment (Pharmaceutical, Aerospace, Aviation, Defence etc).

• You are familiar with PCB Design, manufacture, and test, particularly digital and analogue circuit design and electrical safety.

• Educated to degree level or similar in Electronics Engineering.

For more information, read our Inclusion and Diversity Policy and, to know more about your Human Rights, we encourage you to view this .

Your role:

• Supporting hardware development projects with electronics design in a ISO 13485 / FDA 21 CFR Part 820 quality system. These will either be developing new or refining and enhancing existing features.

• Supporting the team during External system testing, investigating, and resolving issues and formally reporting test results.

• According to the V-Model for system development you will write design specifications, specify components, create schematics evaluating designs and prototype testing.

• Working in close collaboration with suppliers to manufacture prototypes, pre-production units to your designs and into full subcontractor production.

• This role offers you chance for hybrid working from our vibrant & exciting new offices in Farnborough, Hampshire. Additionally, we are open to discuss flexible working requirements to better support your work life balance.

• From competitive salary and yearly performance bonus. Be sure to speak to your recruiter about all the benefits on offer.

You’re right for this role if:

• You career has been in Electrical Engineering (both sustaining and new products).

• You have worked in the Medical Device industry or a similar regulated environment (Pharmaceutical, Aerospace, Aviation, Defence etc).

• You are familiar with PCB Design, manufacture, and test, particularly digital and analogue circuit design and electrical safety.

• Educated to degree level or similar in Electronics Engineering.

For more information, read our Inclusion and Diversity Policy and, to know more about your Human Rights, we encourage you to view this .

Your role:

• First time right NPI (New Product Introduction) project management with respect to costs, schedule, and quality.

• Accountable for the design transfers and manufacturing transfers for EC product industrialization activities related to the factory & Contract Manufacture.

• Communicate and collaborate with the different stakeholders (e.g., supply chain, business, program management).

• Manage the business risks related to Product Industrialization.

• Ensure early involvement in the design process.

• Ensure an optimal supply chain for the NPIs and AOS (assurance of supply) to serve our customers.

• Become a lead in the design transfer processes (like APQP, Process Validation) and drive process improvements where required.

• Create and maintain a diverse, inclusive, and highly engaged team.

• From competitive salary and performance bonus to family friendly policies. Be sure to speak to your recruiter about all the benefits on offer.

• This role is office based, where you will have the opportunity to work from our Farnborough, Hampshire Head Office 3 days a week.

You’re right for this role if:

Education Qualification:

• Bachelor of Science in an Engineering/Technical Discipline or equivalent

• PMP certification or equivalent experience

Technical/Functional Competencies:

• Project management especially in New Product Introduction (NPI) & industrial integration and transfers.

• PMI/PMP Competencies like project management (i.e MS-Project plus Agile/Waterfall project planning & execution.

• Knowledge of NPI, phased releases, and supplier transfers (manufacturing, procurement, and sourcing)

• Change management and lifecycle management fundamentals

• Experience with ERP systems such as SAP or Oracle

• Knowledge in Industry 4.0, digital transformation with AI enablement (preferred)

• Management of CapEx and Non-Recurring Engineering related purchases (preferred)

Behavioral Competencies:

• Experience in leading teams or multi-disciplinary teams & projects

• Aptitude for networking & collaborations

• A flexible mind set, happy to pivot and work in a changing environment

• Result and quality oriented

Process Engineer - NPI & Sustaining

• Partner with key suppliers/ contract manufacturers to develop and improve processes, tools, and equipment of the end-to-end supply chain systems, leading to predictable, reliable, stable and efficient production, order management, materials management anddistribution/logisticsprocesses. Pitcher of new product industrialization projects towards the supplier site.

• Review, escalate, and deploy the product changes from/to suppliers including but not limited to material, equipment, process, end of life, etc.tc.

• Pursue continuous performance improvement (QCDS: Quality, Cost, Delivery, Service)

You will be responsible for:

• Conduct qualification and/or surveillance audits/assessments of supplier business, production, and quality systems to ensure the supplier meets Philips Emergency Care requirements.

• Drive performance management and improvement at suppliers; provide consultancy and/or feedback to supplier to ensure supplier’s systems, methods, tools, and reporting meet customer commitments and expectations.

• Ensure that the products provided by the supplier (including spare parts and services) are released according to agreed specification and quality requirements.

• Lead and support program input in Product Development Lifecycle Management (PDLM) process including DfMAT

• Initiate and execute Capex optimization for investments

You're right for this role if you have:

• BS Engineering discipline or technical field, major in supply chain, operations, or engineering education is preferred.

• Demonstrable experience in Supply Chain Operations, supplier management, manufacturing, quality engineering related functions

• Strong working knowledge of end-to-end supply chain, product development process, quality management practices and business acumen

• Have good analytical skills that includes utilizing six sigma and lean

• Experience and success in working with supplier leadership teams to gain support and action where needed to meet business and customer requirements and expectations

• Ability to work in a cross functional environment at remote locations

• Strong interpersonal and communication skills required

• Detailed knowledge and experience executing APQP (Advanced Product Quality Planning) and related PPAP (Production Part Approval Process)