דרושים Mechanical Designer - Plastics Stet ב-Philips ב-הודו

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·
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  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.
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• 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 .

• Analyzes and troubleshoots testing failures, documenting them in the anomaly database, initiating corrective actions as necessary and ensuring respect for established protocols, working under general supervision.
• Executes targeted development assignments within the defined scope, complies with working agreements with teams, making timely and effective decisions to achieve closure on work items.
• Synthesizes proven approaches and integrates multiple strategies to solve complex problems or optimize solutions in product designs and manufacturing processes.
• Develops and implements new product designs and design improvements for instrumentation in the medical device field, ensuring alignment with customer requirements.
• Participates in the technical development of a Continuous Integration and Continuous Deployment framework for multiple initiatives, ensuring process optimization and efficiency.
• Conducts preliminary studies and modifies subsystem designs to address complex problems, deriving specifications from customer requirements and ensuring adherence to regulatory standards and company quality systems..
• Collaborates with engineers to devise integration phases, criteria, and tests, assists in the designing of features for digitally-assisted medical solutions and supports installation, integration, and monitoring of external clinical sites.
• Keeps abreast of developments within the field, exchanges information effectively to promote cross-functional collaboration, interacts with stakeholders to ensure alignment on project goals and timelines.
• Conducts experimental activities related to test project outcomes, analyzes data, and evaluates results to inform decision-making and implementation of improvements.

• Specify image chain requirements as part of a development project and Test and verify image chain component (Generator, Tube, Collimator, Detector, Monitor etc) against the requirement
• Be responsible for integrating image chain components, adjustment & calibration and verifying the system with respect to meeting the safety, functional, performance and reliability.
• Be responsible for selection of image chain components and subsystems to achieve target cost and image quality.
• Be responsible for detailed technical design for the components including DFMEA, Risk assessment.
• Lifecycle management of image chain components including obsolescence management.
• Collaborate with cross-functional/cross regional teams to release design changes and customer support
• Align with supplier on the requirements and design aspect to ensure products quality.
• Evaluate New and competitive technology for image chain subcomponents.
• Good team player with ability to work independently and act pro-actively.

Minimum required Education:

• Electrical/ Electronic/Biomedical background (B.Tech/M.tech) with 8+ years’ experience
• Solid experience with Power electronics and electronics product design and development
• Analog and Digital circuit design. familiar with Operational amplifiers, Inverter design ( SiC technology) , H- bridge design , Power transformers design
• Understanding X-ray Physics, having Generator, Tube, Collimator, Detector or Monitor knowledge is plus
• Strong understanding of Medical QMS and lifecycle management processes.
• Strong Communication skills: Ability to present technical data/concepts concisely and effectively to various audiences/stakeholders
• Understanding medical standards like IEC 60601-1, IEC 60601-1-3, IEC 60601-2-54
• Detailed/ Structured documentation practices and decision making
• Analytical/Fact Based/Logical problem solver

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 .

The Electrical Designer will also be responsible for Electronics/ Electrical component obsolescence management, Reactive and Proactive obsolescence management, Redesign for cost reduction and improved reliability, Redesign for obsolescence mitigation, Failure, and root cause analysis, Alternate component sourcing, limited software release support, and regulatory updates are common sustaining activities.

Your role:

• Drive product development activities including development of design concepts, prototype testing, engineering specs, and module/system level tests.
• Drive continuous improvement projects related to design implementation, manufacturing process, product quality and reliability
• Work with Systems Engineering, Electrical and other cross functional team members to design electronic enclosures to meet system level functional and architectural requirements.
• Assess & create a Product Change Notification document for each change request/product defect.
• Root cause investigation of electrical issues that involves analysis of Schematics, board layout, assembly drawing and Bill of Materials.
• Assist in evaluating alternate components that are going in EOL, and lead design and qualification of alternate components at the system level.
• Create Module Requirements/Char Specification document for electrical modules
• Develop Test protocols which includes Module Verification plan & report
• Execute module verification testing and log results
• Perform release activities includes Design Verification Review, Design History File (DHF) update and write Memo’s as needed

You're the right fit if you have:

• Masters/ Bachelors in Electrical / Electronics Engineering from an accredited university
• 10 years minimum of experience in product design and development.

Skills

• Extensive experience in Analog and Digital circuit design experience preferably from Medtech industry
• Hands - on experience in component obsolescence management primarily in medical devices, consumer electronics, Automotive OEMs
• Expertise in design and deployment of test fixtures for module and system verification
• Experience with medical device standards (IEC 60601, ISO 13485, FDA 21 CFR Part 820)
• Cross-functional collaboration
• Root cause analysis and failure investigation by using Methodical, effective troubleshooting/problem solving skills.

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 the lives of others.
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Mechanical Engineer

Job Description-

You are responsible for executing engineering requirements analysis, developing, and validating test plans, and ensuring compliance with regulatory standards, working under general supervision. The role documents design specifications and results, implementing design improvements, and troubleshooting technical issues, while mentoring junior team members. The role participates in design reviews, provides insights for continuous improvement, and adheres to company policies and quality standards. The role evaluates external vendors and technologies for integration, maintains component performance and reliability, and fosters strategic partnerships to enhance product innovation

Your role:

• Design and detail components and systems
• Obtain parts and create prototypes.
• Successfully interact with associates in other departments, such as Manufacturing Operations, Procurement, and engineering staff, to achieve project and product objectives.
• Be a highly motivated, self-disciplined, open-minded individual possessing hands-on skills.

• Requirements detailing, design specification preparation, implementation, test, and integration of Unit per the higher-level Requirement and - Design specifications/architectures.
• Ensures the mutual consistency and efficient integration of the separate modules in modular, easy-to-maintain units that meet the product specification.
• Understands and communicates the consequences of their design on the architecture.
• Determines the Unit interfaces (HW/SW) in close consultation with relevant disciplines.
• Ensures that there is proper documentation for his/her design.
• Keeps abreast of technical developments in own field through study of the literature and technical contacts and propagates it.
• Define, execute, and take the lead in concept and feasibility studies with a limited scope to investigate the usability of new technologies.
• Contributes to technology roadmaps and other strategic-related activities.
• Takes technological or process-related improvements initiatives within the scope of at least the mechanical development group.
• Contributes to the Work Breakdown Structure/ the planning process of his/her area.
• Draws up personal schedule and reports on progress.
• Inspires team members to get the job done.
• Performs work in line with the processes that have been agreed in the department.

You're the right fit if:

• Bachelor's Degree/ Vocational Education in Engineering, (8 to 10 years exp)
• 8-10 years of relevant experience in design & development of electro-mechanical sub-systems & systems.
• Strong communication and collaborative abilities proactively seek out expertise and advice and input from others in a collaborative team-environment, Project Management skills (Dealing with suppliers)
• In-depth knowledge and 8+ years of experience in the development of mechanical design
• Experience in creating design concepts and mechanical designs of complex parts or assemblies.
• Strong knowledge and experience in CAD/CAE. such Creo, NX,, LCM- Life cycle management.
• Experience in metal or plastic crafts would be appreciated
• Experience in PDM/ PLM (Windchill)
• Good knowledge of Development methodology
• Six Sigma green belt is a plus

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 .

to make life better

In this role you will bring innovative clinical solutions in 2D and 3D imaging and to our customers around the world. We help physicians to decide, guide, treat and confirm the right care in real time during a minimal invasive procedure to enable better outcomes for each patient. We touch patients’ lives when it matters most and we aim to do it in the most reliable, effective and sustainable way.

You are responsible for

Leading a full product(s) release cycle to ensure quality and compliance

Translation of user and business requirements into product requirements

Managing complexity of products in a multi-disciplinary and international set-up

Lead technically the requirements, design & product specifications for the system / subsystem

Monitoring and managing that the requirements and design is implemented correctly by the Agile Release Train

Drive design for Quality, Reliability and Serviceability of the system / subsystem

Performing safety analysis according to applicable medical device standards

Complying to all applicable medical standards / regulations such as CE (EU-MDR) and FDA

Support regulatory submissions activities

Support project manager on realization, planning and budgets

Contributes to future studies, technical concepts and program roadmap

Support post market surveillance activities

To succeed in this role, you’ll need a customer-first attitude and the following

Master's degree or equivalent in Engineering

Overall 15+ years of experience in the industry,several years of experience in designing & developing medical devices / products

Knowledge of IEC standards, risk management, verification and validation of software medical devices

Knowhow of design control processes for medical device design.

System thinking mindset and domain expertise in the related area.

Excellent communication skills

Leadership skills and drive for results

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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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You are responsible for

• Supporting product verification through the phases of the Medical Device lifecycle.

• Providing technical support and leadership on a cross-functional team

• Define, document, and continuously improve verification tests including conducting peer reviews and maintaining traceability to requirements

• Perform verification tests and conduct analysis of the test results to ensure complete verification of the requirements

• Identifying, analyzing and driving technical issues to resolution

• Perform work with little to no supervision as department subject-matter expert

• Participates in design reviews, including reviews of design verification plans, reports, and test artifacts.

• Development and execution of validation test plans , test records and Test fixtures

• Keeps abreast of new developments in all relevant technological domains.

• Provides technical leadership to ensure overall product development success.

• Keeps abreast of new developments in all relevant technological domains.

• Contributes to technology roadmaps and other strategic related activities

• Provides technical leadership to ensure overall product development success.

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

• Bachelor’s degree in Electronics/Computer Science/Electrical Engineering or related field, good to have a Master’s degree.

• Total 5+ years’ experience with Minimum 3 years of experience in medical device or other similar industry

• Demonstrated knowledge of global quality and regulatory environment for medical devices including FDA CFR 21 part 820.30 and IEC 60601-1-1 (CE mark), ISO 13485, and risk management requirements and development dependencies.

• Solid understanding of medical device product development, preferably Design Control experience with Class-III/Class-3 medical devices (FDA CFR Title 21, 820.30)

• Experience specific to product verification.

• Solid understanding of System Verification and Validation test plan/protocols, executing V&V activities, generating, and analyzing test reports

• Experience in designing and assessing compliance to national/international standards.

• Strong technical writing/documentation skills for a regulated medical device design environment, including requirements definition

• Proven ability to communicate in both verbal and written form to technical and non-technical customers, stakeholders, and various levels of management.

• Possess strategic agility/vision: Sees ahead clearly; can anticipate future concerns.

• Develops and maintains effective relationships and is capable of quickly earning trust and respect.

• Ability to study and understanding of Schematics and PCBA

• Board bring up experience.

• Good Knowledge of EMI/EMC (IEC- 60601-1-2)artifacts and testing , ISO 14971 (Risk Management), IEC 62304 (Software Lifecycle).

• Strong knowledge of embedded systems, real-time operating systems (RTOS), and microcontroller-based architectures.

• Proficient in test development tools, scripting languages (Python, Shell, etc.), and test automation frameworks.

• Experience with communication protocols (I2C, SPI, UART, CAN, BLE, etc.).

• Experience with hardware-in-the-loop (HIL) and system simulation environments.

• Experience with version control systems (Git) and requirements management tools.

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Job Title

Job Description

The primary function within this role is to execute Manufacturing Engineering activities through the course of high-quality process Verification & Validation activities.

In this role you are responsible to sustain and improve processes, tools and equipment of the Manufacturing systems, to ensure predictable, reliable, stable and efficient production processes. Supporting troubleshooting activities. Catcher of new product industrialization projects and manufacturing transfers for the site.

You will be responsible for driving meaningful and innovative Process Validation and suggesting in improving the process and support in Process Verification , Validation , IQ,OQ,PQ to improve quality and reduce cost, as well as performing the role of a technical lead in taking the product development through manufacturing release while transferring products from Engineering to Manufacturing and manage sustaining of different devices by following PDLM-MLD process.

In this role, you will be responsible for supporting Philips business like MRI, RF, IGT, SR&C DXR etc, you will ensure that all processes are capable to deliver consistent output as per-defined specification & consistent with the higher-level requirements

You are responsible for

• Is catcher of PDLM subprojects from Product Industrialization Engineer for a specific technology
• To follow the good manufacturing practices (GMP) .
• comprehension of DMR translation to production processes.
• Provides input for Manufacturing requirements in PDLM.
• To guide and perform PV related tests (e.g TMV, IQ, OQ & PQ) on the shop floor.
• Creates Quality Control Plan and Work Instructions
• Oversees equipment installation and supports ramp up of specific processes at the site
• May execute equipment installation and supports ramp-up of specific processes at the site
• Supports implementation of design changes
• Execute improvements in manufacturing processes, tools and equipment. This is for quality and efficiency improvements.
• Applies lean manufacturing principles
• Employs equipment, practices, and procedures which promote a healthy, safe, and secure work environment
• Executes the processes and standards with embedded quality into the way of working including adherence to compliance with safety, Cost regulatory- and environmental requirements as well as local laws, Philips General Business principles and other policies.
• Initiates and oversees process technology development activities in the context of New Product Generation as well as product and solution technology roadmap.
• Ensures adherence to the applicable process for product introductions, qualifications and release
• Responsible for Manufacturing input in PDLM process focusing on DfMAT
• Can lead & support quality-related problem-solving and root cause analysis during design and manufacturing
• Uses post-market analytics and statistics to report on product quality performance in the field (provide feedback to manufacturing, suppliers, or design teams) and initiates field actions when required
• Oversees equipment installation and supports ramp up of specific processes at the site
• Gives input from factory side to the sign-off at SR milestone & project close Implements
• Lead, prepare, and participate/be the main escort in internal and external audits
• Frequently interacts with supervisors and functional peer groups. Interaction normally requires the ability to gain the cooperation of others, conducting presentations of technical information concerning specific projects or schedules.
• Review/leadership for control of nonconforming products (QNs/MRB), including risk assessments.
• Review/leadership for product nonconformance investigation activities.
• Review/leadership for DEFOAs.
• Review/leadership for receiving inspection plans (RIPS)
• Review/leadership for Process Validation protocols and reports.
• Review/leadership for CAPA investigation activities
• Review/leadership for design/process changes (ECO/CRB)
• Assists, produces and completes STET Quality & Process Engineering related activities and documentation under direct supervision.
• Assists in ensuring that STET project supplier components / products (including spare parts and services) are released according to agreed specifications and APQP – PSW quality requirements.
• Assists in the support of CoNQ projects, and project management in the effective and timely risk
• Support of Regulatory agency audits and inspections in areas of responsibility.
• Review/leadership relating to accurate recordkeeping (GDPs) • Interface with cross-functional teams to ensure compliance and timely product releases
• Applies lean manufacturing principles

You are a part of

We work directly with our cross-functional and cross-discipline partners, including marketing, clinical specialists, service personnel and R&D, to deliver solutions through the execution of PDLM, Lifecycle, and Solutions Processes, with deliveries that exceed our customers' expectations.

• To succeed in this role, you should have the following skills and experience.
• Bachelor’s or master’s degree in production, mechanical, Electrical, Electronics engineering with 4-7 years’ experience.
• Strong quality assurance management experience, minimum 5 years in quality assurance
• Strong design control and new product development experience
• Strong analytical abilities
• Experience in CAD and PLM software’s
• Professional knowledge in ISO 13485, FDA 820, ISO14971, FDA/MDR/MDSAP
• Knowledge of FDA and IEC Standards is a plus.
• Disciplined team worker, ability to work independently.
• Ability to present ideas and to convince project team members.
• Be structured and self-organized.
• Positive ‘can do’ attitude.
• Quality mindset in analysis and documentation
• Excellent communication, both verbal and written
• Preferably already verification or validation background/ experience
• Design for 6 sigma / DMAIC is preferred
• Design for manufacturing, assembly and testability.
• Understanding special Process like Brazing, Soldering, Cleaning will be added advantage
• Basic regulatory understanding about ISO 13485, ISO 14971 will be added advantages
• Supportive in CAPA analysis
• A background in Data Analytics will be preferred.
• Integrated Supply Chain Management
• Capable to solve complex mfg. process Problem.
• Master data management (system) change Management
• He/ She should be good at Logistics Fundamentals, Manufacturing Fundamentals, Master data management (system), Operational Excellence, Operational Risk
• PMI Competencies (Project Management) or Certification will be added advantage
• Good Knowledge about Procurement & Sourcing Fundamentals
• Product Innovation & Lifecycle
• Capable of working independently in software tools Windchill, Minitab & SAP.
• Hands-on experience on performing Process Validations, Test Method Validations and MSA Studies (Process capability studies).

In return, we offer you.

• A rewarding career in Philips with an attractive package.
• An extensive set of tools to drive your career, such as a personal development budget, training, and coaching.
• Attractive collective health insurance package
• Opportunity to buy Philips shares and products with discount.