דרושים Senior Manufacturing Engineer -pie – Stet ב-Philips ב-India, Pune

Your role:

• Developing and executing the regulatory strategy for new product development, design changes and field safety corrections for US, EU, Canada and RoW.
• Participate in strategic product development, design solutions from the concept phase to the product delivery phase and provide regulatory guidance throughout design and development.
• Responsible for product registrations/approvals for their responsible products within IGT-S portfolio.
• Author and lead 510(k) submissions, pre-sub meetings, EU MDR Technical Documentation, and Health Canada license applications. Lead interactions with regulators/competent authorities throughout the review and approval process.
• Review and validate labelling, marketing materials, claims substantiation evidence, clinical protocols to maintain compliance with global requirements.
• Keep abreast of current regulatory procedures and changes.
• Provide critical input and guidance on regulatory change assessments, risk assessments and regulatory requirements implementation.
• Participate in internal audits and play a key role in (external) audits, related to product submission such as FDA, MFDS, NMPA etc. and notified body audits.
• Lead and enable strong cross-functional partnerships between Regulatory Affairs and all key stakeholders, including R&D, Marketing, Quality, Clinical Affairs and other functions at all levels within the Business Unit.
• Identify areas for improvement in terms of efficiency and compliance for internal processes, work instructions, and forms and apply technical expertise to process improvement efforts. Lead and/or participate in process improvement teams to affect local or cross-business unit changes.
• Provide strategic guidance, mentor and coach the RA resources and project team by being a Regulatory subject matter expert.
• Establishes operational objectives and work plans.
• Work according to the business applicable processes and as ambassador of the Philips values.

(4 x bullets max)
1. Experience- Minimum of 7 years relevant working experience in medical device to regulatory strategy development supporting submissions and product market introductions (required)
2. Skills- Regulatory affairs, 510K, De Novo, PMA, and registrations of medical devices globally (including India) is highly preferred, dossier Preparation
3. Education- Bachelors/Master of Science degree
4. Anything else-

Project planning and management skills (preferred)

Excellent verbal, written communication skills (English) & interpersonal skills.

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 .

Work on achieving a state of high quality performance at our Supplier partners. You will pursue continuous quality improvement through the application of Quality Engineering practices on Philipsproducts/parts/services

You are responsible for

• Reviewing Supplier Quality Agreements
• Analyze defects to determine if they are supplier caused and notify accordingly
• Managing/Issuing/Following up on Supplier Corrective Action Requests
• APQP execution, monitoring and control as part of Sustaining Changes (Life Cycle Engineering)
• Supplier performance monitoring, reporting, improvement and development
• Support Supplier quality risk assessment and mitigation
• Acceptance of products that have gone through NPI process before official release
• Support Supplier audit schedule development and maintenance for audits related to supplier processes, supplier selection,corrective/preventiveaction verification
• Assess and coordinate Supplier Change Requests
• DEFOA analysis and securing reoccurrence

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

• Bachelor’s degree in Electrical/Electronic/Mechanical Engineering (Prefer E&E) or other scientific field, or equivalent experience
• Minimum 10+ years’ experience in supplier quality in a highly regulated industry (PCB/Coils experience is a must, having IPC standard knowledge is added advantage)
• Detailed knowledge and experience of APQP and related PPAP tools
• Well versed in Quality Engineering and Continuous Improvement techniques
• Participated in several NPIs from start to finish
• Direct shop-floor production engineering sustaining experience
• Strong negotiation skills and ability to lead through influence
• Experience having direct working relationships with suppliers
• Flexible mindset and proactive approach
• Excellent communication skills in English
• Willingness to travel up to 20% of the time

In return, we offer you

We welcome you to a challenging, innovative environment with great opportunities for you to explore.

Our benefits are very competitive and designed around your preferences:

• A market conform salary
• 25 Days of leave and the possibility to purchase up to 20 extra days off annually
• 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
• Solid company pension scheme and attractive collective health insurance package
• Opportunity to buy Philips shares and products with discount
• Healthy work-life balance

Job title:
Data Analyst- Design Quality Engineer

Your role:

• In partnership with other functions, execute on defines defining and manages managing the holistic patient/ and consumer user safety, quality and reliability strategy and approach, overseeing execution with focus on data quality and quality of results, driving to sufficient confidence in the product/service prior to and post release to market.​
• On request of the organization, provide the relevant data analytics and effectively analyze and utilize post-market data on the product’s field performance to identify system performance trends and/or improvement opportunities to continuously enhance Patient Safety and product quality and reliability.
• Be a contributing member of the data analytics organization and community.
• Identify opportunities for standardization of data analytics requests, based on frequency of business requests and their impact and priority.
• Align on the standardization of data analytics and drive automation with the team(s) that perform complex data analytics computations and develop advanced, effective and robust data solutions to support the business.
• Execute testing to support the validation of data and data analytics solutions.
• Validating key design inputs like e.g useability, reliability, performance, safety, quality and their related test strategies to ensure appropriate statistical confidence and reliability levels.​​
• Leading quality related problem solving.
• Developingand maintainingthe knowledge and expertise resulting in state-of-the-art approaches to structured, data-driven product development, manufacturing and maintenance strategies that increase confidence and reliability of the safety and quality characteristics of our products. You will help to deploy best practices throughout the business by providing training, coaching and support to relevant functions.

You're the right fit if: (4 x bullets max)
1. Experience.- 8+ of industry experience in field of data analyst for Quality function, understand ISO 13485, preparing Dashboard and analysis.
2. Skills.- SQL, Python, Statistical Methodology, ML Experience
3. Education.- Any engineering
4. Anything else.- Good Communication and presentation skill, experience in SAP/Aries will be added advantage. This is an individual contributor role.
Indicate if this role is an office/field/onsite role.About Philips
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 .

Your role:

• In this role, you have the opportunity toKey Requirement:
  ▪▪
  End to End engineering support for supplier-initiated change requests includes part design, tooling, and manufacturing location changes·
  ▪
  Follow design controls governed by FDA· Should have hands on experience of Design verification, Validation, protocol documentation.
  ▪▪
  Conduct DFM, DFA reviews with suppliers.
  ▪
  Should have hands on experience on Windchill

You're the right fit if you have:

• To succeed in this role, you should have the following skills and experience
• •B.S. in Mechanical Engineering with 8-12 years of proven design engineering and product development experience
  Experience supporting supplier transfer & sustaining projects
• •Demonstrated strong analytical and problem-solving skills
  •Knowledge of manufacturing quality systems and working in a regulated industry
  •Experience with geometric dimensioning and tolerance
  •Strong English written and verbal communication skills required
  •Creates 3D models, assembly and detailing including drawing conversions
  •Apply GD&T and perform Tolerance stack-up analysis for components/Sub-system.
  •Review and ensure adequacy of supplier part qualification activities
  •Performing hand calculations for design feasibility
  •Shall have hands-on expertise in Engineering change Management
  •Provide technical support to suppliers & other departments to fulfil project/productions

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 .

Job Responsibilities:

• Facilitates technical capability assessments of potential new suppliers, ensuring they meet the company's quality standards, and contributes to the supplier selection.

• Conducts & reviews DFMAT (Design for Manufacturing and Assembly Technique), SRPQP, PFMEA (Process Failure Mode and Effects Analysis), Control Plan, SPC (Statistical Process Control), PV&V (Process Validation(IQ/OQ/PQ/TMV) and Verification), FAI (First Article Inspection), LRA (Line Readiness Assessment), and SICR (Supplier Initiated Change Request).

• Develops, executes, monitors, and controls APQP (Advanced Product Quality Planning) plans as part of the NPI process to ensure consistent product quality.

• Contributes to the content of the Supplier Project Book, documenting detailed quality requirements and expectations for suppliers.

• Facilitates collaboration between R&D and suppliers in Design for Excellence (DfX) initiatives to enhance product design quality and innovation.

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

• Coordinates Part Submission Warrant plans, deliverables, line releases, and completion, ensuring all parts meet specified quality standards before approval.

• Executes supplier improvement and development initiatives on APQP(Advanced Product Quality Planning), providing guidance and resources to enhance supplier processes, ensuring they meet the high standards required for production quality and efficiency.

• Assists with the process of making additions, changes, or deletions to the Approved Supplier List, ensuring that only qualified suppliers are retained.

• Supports in end to end performance management of suppliers, conducts detailed analysis of defects to determine if they are supplier-caused, and acts as an independent reviewer for Supplier Corrective Action Requests.

Bachelor's/Master's Degree in Engineering Science, Mechanical, Electrical Engineering, Electronic Engineering or equivalent.
Minimum 12-15 years of experience with Bachelor's in areas such as Quality Engineering, Safety Engineering, Process Engineering, Process Validation, Continuous Improvement TechniquesB.E Electronics/Mechanical/Electrical

LEAN Six Sigma or equivalent.
• Supplier Quality Management
• Quality Management Procedures and Methodologies
• Supplier Evaluation Methodologies
• Data Analysis & Interpretation
• DfX Methodology
• Supply Chain Management (SCM)
• ISO13485:2016, FDA 21CFR 820
• CAPA Methodologies
• Statistical Process Control (SPC)
• Measurement Systems Analysis (MSA)
• Process Validation(IQ/OQ/PQ/TMV)
• First Article Inspections
• Documentation & Reporting
• Regulatory Requirements
• Continuous Improvement

Our hybrid working model is defined in 3 ways:

Test and Verification Engineer

Be part of a multidisciplinary team of highly skilled technical specialists working on innovative (automated) test solution projects. These projects can cover every phase of the product life cycle, from development, manufacturing (manufacturing test development, fitness for use, MSA’s) and maintenance. In your role, you will work with together with Test architects, the SW architects (automation) and other T&V Engineers from within our own organization as well as from our customers organization.

You are responsible for

• Software Development for ATE(Automated Test Equipment), test setup, tools in the technologies like LabVIEW, Test Stand, MATLAB, Python language
• Designs, develops, evaluates, and conducts integration, testing, and verification activities of (elements of) products with focus on electrical, electronics, mechatronics and (embedded) software aspects and concludes this with formal reporting.
• Developing, executing, and documenting test protocols (for elements, (sub)system integration, functional and non-functional tests) against the test requirements by using established test methods, techniques and tools.
• Take ownership on developing and conducting tests to verify functionality (performance, reliability, safety, security, compliance) and formally reporting the results.
• Analyzing and post-processing of measurement data by using statistical techniques (Minitab) and providing technical documentation in compliance with internal procedures and regulations/ standards applicable (e.g. according to ISO 13485, ISO 17025 21CR820 and GDP, IEC 60335)
• Prepare test documents, technical reports, presentations, as required.
• Setting up and maintaining both large and small scale device testing

To succeed in this role, we are looking for a System Test & Verification Engineer with following characteristics:

• Batchelor’s or Masters degree in electronics, Electrical, mechatronics engineering
• 4 - 6 years of experience in R&D area or manufacturing (design engineering, test development, manufacturing, quality assurance or research) Good understanding of product development and or design verification process of industrial products, medical business is plus
• 3+ years of experience in System/Product test automation , test designing, executing, reporting and excellent documentation skills.
• Experience in LabVIEW, Test Stand, HIL, MIL, MATLAB, Python / Arduino, scripting languages
• Experience in using test & measurement hardware like Function Generator, Multimeter and power supplies, Industrial Sensors and transducer etc.
• Knowledge of Advanced LabVIEW software architecture development skills.
• Working Experience in Industrial automation protocols like Ethernet, UDP, TCPIP, RS232, RS485, MODBUS, OPC Server, CAN, LIN, I2C.
• Working experience on NI Hardware like cDAQ, cRIO.is plus
• Professional in Execution of detail test plan from system to component level in the domain of functional Performance, Reliability, and compliance
• Good at applying concepts and implementing in test and verification field.
• Structured approach in planning, test execution and defect identification and closure.
• Knowledge of medical device regulations and standards (e.g., IEC 60601-1, EU-MDR, FDA cGMP) is plus
• Exposure on Requirements analysis, Traceability Matrix and Risk Management
• Affinity with Systems engineering and Requirement engineering is plus
• Open to travel at different sites on an occasional basis
• Excellent working with others with a strong sense of teamwork and collaboration
• Strong desire to learn and adapt to new technologies and challenges
• Good communication skills analytical thinking, physical insight, continuous learning mindset

Good to have

• Knowledge of Machine Vision strategies.
• Knowledge to understand electric wiring diagram Participating in the development of verification test plans for HW and SW domain.
• Understanding of embedded architecture and hardware interfaces

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 .