You are responsible for:

• To drive compliance of Design control requirements and ensure product design quality met in new product development as well released product.
• To ensure radiation safety regulations and requirements as per IEC standard / FDA guidelines are met in the product design
• Challenge the status quo on EMI/EMC impacts during product design change
• Collaborate with R&D Compliance team for CDR development in NPI
• Monitor design control requirements are adhered in the NPI project as part of project core team
• Provide appropriate decision on project readiness to next phase / milestone considering quality aspects TOP 10 Mnc company Jobs in India – December 2024
• Provide necessary process guidance and compliant solution to project team

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

• Engineering degree in Mechanical or Electronics/Bio medical /Life sciences
• Minimum ~15 years hands on experience in X-ray machines, Radiation devices (Subchapter J), IEC 60601 standards, along-with knowledge on Risk management and Medical device quality system for product development TOP 10 Mnc company Jobs in India – December 2024
• Profound knowledge on IEC 60601 compliance standards, Radiation safety requirements e.g. 2-54, Subchapter J Radiological Health and Product quality aspects
• Sound knowledge of implementing and sustaining Quality Management system  compliance as per ISO Regulations (ISO13485/ USFDA QSR)

Your role:

• Cultivates effective relationships, shares knowledge, provides influence over projects and peer groups, demonstrating full understanding of area of specialization, and possesses working knowledge of appropriate global regulations, requirements, and standards such as 21 CFR Parts 803, 806, and 820, ISO 13485, ISO 14971, and ISO 9001.

• Validates key design inputs like usability, reliability, performance, supportability, manufacturability, localizability, safety, security, privacy, serviceability, sustainability and costs.

• Possesses knowledge of design principles for complex, durable, electro-mechanical medical devices.

• Independently produces quality engineering documents, coordinates quality plan design for hardware/software and system design, and supports stakeholders during the execution of quality system, product audits, and inspections.

Your role:

Sells assigned portfolio of products within an assigned geographic territory, negotiating with clients and managing sales of products through a Distribution led traditional trade setup.

· Achieving established revenue growth expectations within assigned territory, and achievement of monthly/quarter/annual selling out target in his/her area.

· Develops and executes territory business plans driving product usage, brand recommendation (MOR, Most Often Recommended), to meet and exceed direct sales targets.

· Partners with inside sales and marketing teams to optimize area covarage. Understands and selects the right promotional tactics to optimize sales, responsible for maximizing promotions · Conduct monthly/quarterly/annual business review with in his/her respected area.

You’re the right fit if:

Typically requires a MBA degree and 8+ years of related experience

Proven sales experience 

Track record of over-achieving quota

· Experience working with Distribution led sales setup.

· Familiarity with different sales techniques and pipeline management

· Computer use competency

 · Strong communication, negotiation and interpersonal skills.

Your role:

• Develop competency of system engineering for large complex CT & AMI systems.
• Audit support for CT/AMI Pune owned product for various regulatory agencies (FDA/CE/etc)
• Applies Philips Excellence practices to identify and solve major product quality issues.
• Customer satisfaction by providing faster engineering resolution to the issues faced by customer.
• Owns post market KPIs (Complaint/CAPA/Defects)
• Collaborates with Global system engineering groups in CT/AMI and adopt good practices.
• Develop strategy for knowledge build up for execute strategy to transition Pune as CoE for Life cycle management products. TOP 10 Mnc company Jobs in India – December 2024
• Lead team of System & System software engineers

You’re the right fit if:

• B.E./B.Tech. or higher with >15 years in leading medical devices / products development / maintenance., including >6 years Systems/ Software engineering.
• Manage relationships with global stakeholders to understand their requirements and expectations. Effectively coordinate and allocate resources to meet stakeholder needs and project objectives.
• Excellent communication skills and handling of stakeholders.

Key Areas of Responsibility:

• Performs the role of a Project manager
• Provide technical guidance, review support to the test team( manual and automation). Support & train test engineers on process/domain
• Formulate the test strategy for a product/subsystem including test automation
• Participates in Review of test deliverables.
• Handle the estimation, planning , resource identification and risk management activities related to test automation. TOP 10 Mnc company Jobs in India – December 2024
• Lead and participate in test case development, review, execution, reporting and traceability.

Role Competency:

• Bachelor degree in engineering or other relevant discipline
• 10+ years of experience on test discipline, test strategy, test automation
• Prior experience of playing the role of Project Management with Verification background
• Expertise in test strategy, test design skills and able to guide the team on these.
• Hands on Experience with automation framework development is advantage
• Experience in healthcare/Medical Devices industry is preferred.

You are responsible for

• The realization and management of product test and verification in product creation projects.
• Reviewing product requirements, designs and product changes from a test point of view and liaising with stakeholders resulting in a testable and maintainable systems and converting requirements into test specifications and tester designs. TOP 10 Mnc company Jobs in India – December 2024
• Creating, reviewing and optimizing test designs, reusable test protocols, and test procedures to ensure complete functional and non-functional test coverage for multiple project and/or products concurrently.
• Developing, executing, and archiving objective, reproducible and maintainable test designs and test protocols/procedures (for elements, (sub)system integration, functional and non-functional tests), by using test design methods, techniques and tools.

To succeed in this role, we are looking for a Test Developer with following characteristics:

• Bachelor’s or Master’s degree in Electronics /Electrical Engineering.
• 8 -12 years of experience as a Test and Verification lead/senior Engineer in an industrial product R&D environment.
• In-depth knowledge and a proven track record in implementing and applying concepts in test and verification and test management field.

You are responsible to:

• Develop and implement comprehensive OT security strategies that aligns with industry best practices and regulatory requirements.

• Build IT/OT SOC, execute OT incident response

• Identify OT vulnerabilities and perform remediation without causing system unavailability.

• Deploy Firewalls to segment OT systems from other standard IT environments.

• Define Security Policy Framework customised for Supply Chain Technologies

• Identify appropriate tools/solutions in the areas of inventory collection, vulnerability management, antivirus, endpoint detection and response

Qualification

• Bachelor’s or master’s degree in information technology and or commensurate experience in delivering security solutions.

• Overall Enterprise IT Security experience of 12 yrs or more.

• Security Certifications such as CISSP, CISM, CISA, CIPP etc. preferred.

Your role:

• Facilitate product and process Corrective and Preventive Action (CAPA) investigations from issue identification through implementation of solution and effectiveness monitoring.

• Project manage all aspects of CAPA activity which includes gaining the commitment of cross functional resources, scheduling CAPA team meetings, and ensuring CAPA deliverables per project timelines.

• Represent CAPAs during audits and CAPA Review Board meetings.

• Lead and mentor cross functional teams with the implementation of appropriate root cause analysis techniques (e.g. Pride problem solving).

You’re the right fit if:

• Bachelor’s or Masters degree in an engineering or scientific-related field or equivalent demonstrated strong technical competence

• 6 + year of experience in medical device or other regulated industry. Working knowledge of appropriate global regulations, requirements, and standards such as 21 CFR Parts 803, 806, and 820, ISO 13485, and ISO 9001, and ISO 14971

• Good project management & stake holder management skills

• Qualified expert with good experience in the CAPA engineering field

• Structured & process-oriented individual with ability to apply company policies and procedures to resolve a variety of issues

Your role:

Develops and maintains relations with existing and potential customers for assigned accounts (typically transactional accounts).
• Creates yearly sales plans, with the help of sales management, to set targets and to plan actions and MarCom deliverables.
• Creates, together with marketing, services and supply chain teams, the optimal offers to the accounts.
• Initializing customer tailored sales actions and may support larger sales actions.
• Monitoring the quality of the realization of the actions, improvement of contact between the internal service and the customers to get a good result of the actions.
• Makes local presentations and explanation on the product portfolio and support to promotions (supported where needed by sales specialists).

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

Bachelor degree with 5+ years of related experience in Sales of Ultrasound Machines