Senior Associate

4 weeks ago

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

Summary of the position:

We are seeking a highly skilled and motivated Senior Associate to join our team. The ideal candidate will have extensive expertise in Design Control of Medical Devices, proficiency with Polarion or similar requirements management software tools, a strong background in systems engineering, and proficiency with Teamcenter PLM tool. This role will be pivotal in transforming and uplifting our Requirements, Standards and Risk management processes from paper-based to digitized states.

Key Responsibilities:

Lead the transformation of Requirements and Risk management processes from paper-based to digital formats. Ensure compliance with Design Control regulations and standards for medical devices. Utilize Polarion requirements management software tools to manage and track requirements. Collaborate with cross-functional teams to ensure seamless implementation into the organization. Collaborate with cross-functional teams to drive harmonization and application of systems engineering principles. Develop and maintain documentation related to requirements, standards and risk management. Provide support and/or training to team members on the use of digitized tools and processes. Identify and implement process improvements to enhance efficiency and compliance.

Qualifications:

Bachelor’s degree in engineering, Systems Engineering, or a related field. Minimum of 2 years of experience in Design Control of Medical Devices. Preferred Experience: +2 years associated with complex medical device design requirements and associated standards (e.g. SIMD medical devices) Proficiency with Polarion or similar requirements management software tools. Strong understanding of systems engineering and modeling principles and practices Excellent analytical and problem-solving skills. Strong communication and interpersonal skills. Ability to work independently, proactively identify issues, recommend and implement solutions, and deliver quality results on schedule while managing multiple tasks and customers Detail-oriented with a commitment to quality and compliance.

Knowledge, Skills and Abilities

Personal Effectiveness Competencies:

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

Skills and Knowledge:

Design Control - Requirements Management including design inputs and design outputs (V-model) Systems Engineering and Modeling STEAM – Applied Science, Technology, Engineering, Arts and Math Project Management experience Superior Excel and/or other database data analysis and visualization tools 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) Preference: Working knowledge of Subversion (SVN) version control Preference: Working knowledge of ReqIF formats Preference: Working knowledge of “state of the art” standard assessments

Experiences

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

Licenses and Certifications

ISO 13485 Training

ISO 14971 Training 

IEC 62366 Training

Language Skills

Fluent English; excellent verbal and written communication skills

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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