Zydus Lifesciences Pvt. Ltd Walk-in Interview .Zydus Lifesciences Pvt. Ltd Notification full details below.Interested and eligible candidates can attend Interview on scheduled time and venue..
Vacancy details:
- Department: Design Quality / Mechanical / System / Software / Electrical / Verification & Validation
- Experience:1-3 / 3-5 / 5-8
Important Details :
- Selection Process: The selection will be on the basis of Interview.
- Mode of Interview: Face to face
- Interview Rounds of Interview: HR
Walk-in Location – Hotel Radisson Blu, 136/1, Hinjewadi Phase 1 Rd, behind Mahindra International School, Phase 1, Hinjewadi Rajiv Gandhi Infotech Park, Hinjewadi, Pune, Pimpri-Chinchwad, Maharashtra 411057. Contact Number – 020-69528000
Job Location – Ahmedabad
Date – 11 May 2025 Time – 9:00 am to 6:00 pm
Role – Design Quality / Mechanical / System / Software / Electrical / Verification & Validation Exp – 1-3 / 3-5 / 5-8
Please find below detailed JD for each role –
R&D – Design Quality
Job Description Summary
Roles and Responsibilities
- Create a Quality culture by driving compliance activities around a specific product, site or region. This includes being responsible for the total quality management system for the business and driving Quality metrics. Ensures quality and regulatory compliance while driving process effectiveness and efficiency. Represents to external agencies and champions the evolution of the quality culture which includes executing and driving quality objectives, metrics, reporting and operating mechanisms.
- Experience in Medical Device QMS processes.
- Has ability to organize, drive rigorous compliance of and lead a successful QMS processes at a medical device facility.
- Communicates complex messages and negotiates mainly internally with others to adopt a different point of view.
- Uses high level of judgment to make decisions and handle complex tasks or problems that impact the site’s compliance. Has ability to assess quality of information given and ask pertinent questions to stakeholders. Able to offer new solutions to problems outside of set parameters and is able to construct and provide recommendations. Uses multiple internal and some external sources outside of own function to help arrive at a decision.
- Ensures process compliance through the development of comprehensive procedures, work instructions, flowcharts, forms, templates, checklists, worksheets, and other product and process related documentation.
Required Qualifications
- Minimum of Bachelor’s Degree. Experience in establishing Design Quality Control, Assurance, Regulatory Affairs teams & competence development from the scratch within a regulated industry.
- Ability to effectively communicate technical information in English (both written and oral).
- Experiences in the understanding & interpretations of Risk Management, Design Controls, Standards & Regulations, CDSCO, FDA, MDSAP, etc for Class 2 and Class 3 devices
Desired Characteristics
- Experiences in developing Design Quality Engineering & Quality assurances for Cardiology, Nephrology, Imaging
- Demonstrated understanding or aptitude to understand Medical Device QMS requirements and regulatory requirements including but not limited to FDA CFR 21 820 and ISO 13485, ISO 14971, ISO 12417: 2024,ISO 25539:2020, etc.
- Demonstrated expertise to effectively communicate within all levels of the organization around concepts of design controls, production & process controls, Corrective & Preventive Action (CAPA), complaints & risk management.
- Demonstrated collaboration, negotiation & conflict resolution skills. Demonstrated ability to lead, acknowledge, develop, communicate & implement a strategy under crisis situations to ensure compliance. Experience in a global working environment.
- Experience leading and implementing change. Experience performing internal audits and participating in external audits.
- Exceptional analytical, problem solving & root-cause analysis skills. Ability to multi-task & handle tasks with competing priorities effectively. Strong technical aptitude (i.e. able to read & comprehend technical documentation & execute procedures), global regulatory experience & demonstrated experience interfacing with regulators.
R&D – Mechanical Engineering
Job Description
Roles and Responsibilities
Opportunity to work from scratch, responsible for development of Lab Infrastructure, New Products, Installed Base and Advanced Technology Developments.
- Has in-depth knowledge of best practices and how own area integrates with other functional areas that would help in building products; has working knowledge of competition and the factors that differentiate them in the market
- Uses judgment to make decisions or solve moderately complex tasks or problems in areas of operational/product management, manufacturing, technology or engineering. Takes new perspective on existing solutions. Uses technical experience and expertise for data analysis to support recommendations. Uses multiple internal and limited external sources outside of own function to arrive at decisions.
- Acts as a resource for colleagues with less experience. May lead small projects with moderate risks and resource requirements. Explains difficult or sensitive information; works to build consensus. Developing persuasion skills required to influence others on topics within field.
- Experiences of Plastics, Casting, Simulations & Modelling
Required Qualifications
- This role requires experience in the Mechanical Engineering/Technology & Design Engineering Management.
- Masters Degree or Bachelor’s Degree in Engineering (specialized in Mechanical / Manufacturing) or Physics, or equivalent experience
- Relevant Medical Devices Design work experience in New Product Development
Desired Characteristics
- Strong oral and written communication skills.
- Strong interpersonal and leadership skills.
- Demonstrated ability to analyze and resolve problems. Demonstrated ability to lead programs / projects.
- Ability to document, plan, market, and execute programs. Established project management skills.
- Aware of and comply with the Regulated industry, such as Medical or Pharma Quality Manual, Quality Management System, Quality Management Policy, Quality Goals, and applicable laws and regulations as they apply to this job type/position
- Complete all planned Quality & Compliance training within the defined deadlines
- Identify and report any quality or compliance concerns and take immediate corrective action as required
- Drive compliance/closure of Regulatory and Quality requirements before approving Design Outputs/Program Deliverables
- Identify continuous improvement activities by initiating the implementation of process and product quality improvement initiatives
R&D – Electrical & Electronics Engineering
Job Description
Role Responsibilities
- Looking for talents in the field of Electrical & Electronics Hardware Engineering, including Embedded Hardware Engineering.
- Expertise in India & global Medical Devices Design Controls, Quality Management System, Standards & Regulations, such as ISO 13485, 60601, 14971, etc
- Lead/contribute to Electrical & Electronics technical solutions and products.
- Lead/contribute to a project team, a tiger team, or a process improvement initiative.
- Design, analyze, integrate and document products, systems or subsystems
- Provide technical guidance and oversight to include concept development and peer/design review participation.
- Support verification testing, transition to production, and field issue resolution.
- Provide budget, cost, and schedule input.
- Participate in proposals.
- Mentor engineers/designers.
- Support, communicate, reinforce, and defend the mission, values and culture of the organization.
- Inspire team’s engagement in all phases of product development.
Required Qualifications
- Bachelor/Master of Science in STEM (Electrical & Electronics engineering preferred)
- Professional experience in hands on project, 5+ years in people leadership within a product development or research development environment.
Desired Characteristics
- Demonstrated ability to deliver results while working on multiple projects simultaneously, balancing resources, timing, and quality of outcomes.
- Experience with medical devices.
- Master’s degree.
R&D – Software Engineering
Strategy and Execution
- Executes on the organization’s strategy, providing clearly defined success criteria and levels of accountability for individuals in the team. Removes impediments for the progress of the teams and acts as escalation point.
- Focuses on customers by understanding their needs to design and implement solutions.
Quality & Craftmanship:
- Consistently delivers high Quality software at a sustainable speed, maintaining an advanced level of software craftmanship as established by the SW CoE.
- Ensures adherence to all applicable development processes, Standards & Regulations, Cyber security, legal, quality, security and regulatory requirements.
Technical Engagement & Collaboration:
- Being a Technical, Hands on Subject Matter Expert in the field of Software Engineering, including Embedded Software Engineering.
- Contributes to the technical innovation of the product and/or systems which the teams are accountable for by providing insights, hands-on technical reviews and continuous feedback.
- Stays up-to-date on the relevant technology domain. Enjoys self-learning and brings new technical practices and innovations to the team.
- Collaborates with relevant internal and external parties establishing an effective network to obtain input on technological developments, identifying trends and opportunities.
- Executes on continuous improvement in processes and ways of working to achieve operational excellence.
- Makes informed business and technical decisions quickly as the result of well-directed data gathering, effective analysis and good judgement.
- Balancing the tension between daily tasks and the long-term strategic vision of the organization.
You’re the right fit if:
- B.E/B/Tech or Master’s degree in Computer Science Engineering, with a solid technical understanding and interest
- Experience in SW development industry, preferably in the Healthcare domain.
- Intrinsic willingness to involve in designing/coding (in any programming language) whenever team demands.
- Experience in Vendor management-from SOW definition
- Strong communication and performance management skills
- Open and collaborative personality
Functional competencies:
- Software Applications-architecture, design and development
- Strategic road mapping aligned to business goals
- Scaled Agile Framework
- Project management
- Knowledge in Mobile, Full stack, Desktop, Web and backend development
- Software automation & test development framework
- Continuous improvement
Behavioral competencies:
- Entrepreneurial mindset.
- Role model behavior and culture (as mentioned below)
- Customers first
- Patient Safety, Quality and Integrity
- Team up to win
- Take ownership to deliver fast
- Eager to improve and inspire
- Speeds up transformation to shape our future.
- Develop people & upgrade capabilities.
R&D – Systems Engineering
Your role:
- Being a Technical, Hands on Subject Matter Expert in the field of Systems Engineering.
- Audit support for product for various regulatory agencies (CDSCO/FDA/CE/etc)
- Customer satisfaction by providing faster engineering resolution to the issues faced by customer.
- Collaborates with system engineering groups (like INCOSE) and adopt good practices.
- Develop strategy for knowledge build up for execute strategy for Life cycle management products.
- Owns the program deliverables and collaborates with project managers to deliver.
- Lead teams, fostering collaboration to deliver tasks.
- Builds productive internal/external working relationships
- Strategic thinking from systems perspective to convert from reactive approach to proactive and strategic organization
- Innovate on cost reduction, call rate reduction, customer NPS
- Innovate on creating new revenue streams together with marketing
- Develop Systems engineering competency.
- Deliver upgrade solutions as per roadmap to deliver on customer life time value.
- Deliver on obsolescence management of computers/controllers.
- Own and manage firmware deliveries and competencies.
- Co-ordinate and resolve customer escalations.
- Manage product ownership / software subsystem transfers as applicable.
- Recruit, hire, and retain talent with the necessary skills to support projects.
- Conduct performance reviews and on-going coaching and mentoring.
You’re the right fit if:
- B.E./B.Tech. or Masters/PhD in STEM with experience in medical devices / products development / maintenance..
- Excellent communication skills and handling of stakeholders.
- Strong technical background in R&D engineering disciplines (e.g. Electronics, Software, Mechatronics).
- Experience in Medical Device lifecycle management preferred.
- Knowledge and understanding of applicable medical device development standards preferred.
- Experience in managing high performance teams as a people leader – preferred.
- Excellent integral (cross functional) stakeholder/perception management skills.
- Good multidisciplinary (R&D) stakeholder/perception management skills.
- Strong leadership competencies.
- Good people management skills.
R&D – Verification & Validation (V&V)
Job Description Summary
Roles and Responsibilities
- Experience in Verification & Validation of Systems/Mechanical/E&E/Software
- Experience in creating & qualifying V&V Lab infrastructure, Equipment calibrations & Maintenance
- Experience in Design History File, Traceability & such Design Controls
- Creating Verification Plan, Verification Protocol, Verification Test cases, Creating Test Summary
- Experience in Test Automation Tools, including Hardware & Software in loop
- Experience in Lab View Tools
- Experience in Simulation & Modelling tools applied to V&V
- Experience in Medical Device QMS processes, FMEA
- Has ability to organize, drive rigorous compliance of and lead a successful QMS processes at a medical device facility.
- Communicates complex messages and negotiates mainly internally with others to adopt a different point of view.
- Uses high level of judgment to make decisions and handle complex tasks or problems that impact the site’s compliance. Has ability to assess quality of information given and ask pertinent questions to stakeholders. Able to offer new solutions to problems outside of set parameters and is able to construct and provide recommendations. Uses multiple internal and some external sources outside of own function to help arrive at a decision.
- Ensures process compliance through the development of comprehensive procedures, work instructions, flowcharts, forms, templates, checklists, worksheets, and other product and process related documentation.
Required Qualifications
- Minimum of Bachelor’s Degree. Experience in development of from the scratch within a regulated industry.
- Ability to effectively communicate technical information in English (both written and oral).
- Experiences in the understanding & interpretations of Risk Management, Design Controls, Standards & Regulations, CDSCO, FDA, MDSAP, etc for Class 2 and Class 3 devices
Desired Characteristics
- Experiences in developing Design Quality Engineering & Quality assurances for Cardiology, Nephrology, Imaging
- Demonstrated understanding or aptitude to understand Medical Device QMS requirements and regulatory requirements including but not limited to FDA CFR 21 820 and ISO 13485, ISO 14971, ISO 12417: 2024,ISO 25539:2020, etc.
- Demonstrated expertise to effectively communicate within all levels of the organization around concepts of design controls, production & process controls, Corrective & Preventive Action (CAPA), complaints & risk management.
- Demonstrated collaboration, negotiation & conflict resolution skills. Demonstrated ability to lead, acknowledge, develop, communicate & implement a strategy under crisis situations to ensure compliance. Experience in a global working environment.
- Experience leading and implementing change. Experience performing internal audits and participating in external audits.
- Exceptional analytical, problem solving & root-cause analysis skills. Ability to multi-task & handle tasks with competing priorities effectively. Strong technical aptitude (i.e. able to read & comprehend technical documentation & execute procedures), global regulatory experience & demonstrated experience interfacing with regulators.
