Philips Senior Manufacturing Engineer -PIE – STET 

India, Maharashtra, Pune 

950598888

Senior Manufacturing Engineer -PIE – STET

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.