Design Control PPS, Manager

4 weeks ago

bangalore, India IN19 Alcon Laboratories (India) Pvt Ltd Company Full time

Summary of Position:

Maintain legacy products risk management files (RMF) and design history files (DHF) in support of on-shore Risk Management Leads and per Alcon master schedule to support international registrations and/or re-certifications. Support on-shore Project Management Office (PMO) Design Control engineers and Platform engineers and scientists to query, analyze, identify options, prepare and present proposals, document results and conclusions to resolve potential DHF and RMF gaps. Support audit and other compliance activities by querying, analyzing and providing requested information. Lead and manage a team of engineers, providing guidance, mentorship, and support to drive their professional growth and development.

Key Responsibilities:

Prepare, coordinate, document post-production risk reviews per master schedule in support of on-shore Risk Management Leads and subject matter experts; coordinate query with stakeholders and/or data analysts; analyze and summarize post-production data. Update Risk Management Reports (and other risk management file deliverable) when/as needed and route for approval to risk management team. Update traceability matrices to link requirements to objective evidence – using applicable requirement management tools. Support Design Control engineers and other R&D stakeholders to query internal and external databases, analyze data and summarize results and conclusions in an email and/or a report. Collaborate with cross-functional teams, including product managers, designers, and stakeholders, to define project goals, scope, and timelines. Drive the execution and delivery of software projects, ensuring adherence to best practices, quality standards, and project milestones. Foster a culture of innovation, collaboration, and continuous improvement within the engineering team. Identify and mitigate risks and challenges that may impact project timelines and deliverables.

Key Requirements/Minimum Qualifications :

BS of Engineering with 5 years experience; or MS and 2 years of experience Engineering generalist with demonstrated interest in multiple engineering and scientific fields. Ability to work independently, proactively identify issues, recommend and implement solutions, and deliver quality results on schedule while managing multiple tasks and customers. Some knowledge of ISO 14971 and ISO 13485 (or US 21 CFR 820.30) or systems engineering. Some knowledge of Product Lifecycle Management (PLM) or CAD systems. Good interpersonal & Communication skills to build positive departmental and inter-departmental relationships in a virtual, remote and asynchronous environment. Technology savviness to automate simple tasks for process improvement and cycle time reduction (e.g., data queries, data analyses, documentation)

Personal Effectiveness Competencies:

Project Excellence - Intermediate Continuous Learning - Intermediate Digital and Technology Savvy - Intermediate Operational Excellence - Intermediate Breakthrough Analysis - Intermediate Organizational Savvy - Intermediate

Skills and Knowledge:

STEAM – Applied Science, Technology, Engineering, Arts and Math Technical Development Methodology for Medical Devices (21 CFR 820.30, ISO 13485) Systems Engineering or Risk Management for Medical Device (ISO 14971) Regulations and Guidelines Excellent Technical/Scientific Writing in English in a regulated environment Superior verbal English communication skill (in a remote environment) Microsoft Office suite (i.e., Word, Excel, PowerPoint, Visio)

Experiences

Cross Functional collaboration - Primary New Product Innovation - Secondary Accountability - Primary Influencing without Authority - Primary Managing Crisis – Secondary Functional Breadth - Secondary

Work hours: 1 PM to 10 PM IST

Relocation assistance: Yes

Employment Scams:  Alcon is aware of employment scams which make false use of our company name or leader’s names to defraud job seekers. Alcon does not offer any positions without interview and never asks candidates for money. All our current job openings are displayed here on the Careers section of our website, where you can search for open positions and apply directly.

If you have encountered a job posting or been approached with a job offer that you suspect may be fraudulent, we strongly recommend you do not respond, send money or personal information, and check our website for current job openings.

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