Job Summary:

We are seeking for a highly motivated Associate to join the Design Control team. The ideal candidate will have experience in Design Control and Risk Management of Medical Devices, proficiency with Teamcenter PLM or similar product lifecycle management tools and with Polarion or similar requirements management tools. This role will play an important role in transforming and uplifting Design History Files to Teamcenter PLM and maintaining DHF documentation in the PLM system.

Key Responsibilities:

Plan and execute the migration of Design History Files from the current systems to Teamcenter PLM.Develop and maintain Design Control and Risk Management documentation in the PLM system.Collaborate with cross-functional teams to ensure seamless implementation of Teamcenter PLM into the organization.Provide support and/or training to team members on the use of digitized tools and processes.Utilize Polarion requirements management tools to manage and track requirements.Ensure compliance with Design Control regulations and standards for medical devices.Identify and implement process improvements to enhance efficiency and compliance.

Qualifications:

Bachelor’s degree in engineering, or a related field.Minimum of 2 – 5 years of experience in Design Control of Medical Devices (e.g., electromechanical, optical, SiMD/SaMD, combination products).Proficiency with Teamcenter PLM or similar product lifecycle management tools.Preferred: Experience with Polarion or similar requirements management tools.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 - IntermediateContinuous Learning - IntermediateDigital and Technology Savvy - IntermediateOperational Excellence - IntermediateBreakthrough Analysis - IntermediateOrganizational Savvy - Fundamental

Skills and Knowledge:

Design Control and Risk ManagementSTEAM – Applied Science, Technology, Engineering, Arts and MathRegulations and GuidelinesProficiency with Teamcenter PLM or similar product lifecycle management toolsPreferred: Polarion or similar requirements management toolsMicrosoft Office suite (i.e., Word, Excel, PowerPoint, Visio)Technical/Scientific Writing in English in a regulated environmentVerbal English communication skill (in a remote environment)Preferred: Project Management experience

Experiences

Cross Functional collaboration - PrimaryNew Product Innovation - SecondaryAccountability - PrimaryInfluencing without Authority - PrimaryManaging Crisis – SecondaryFunctional Breadth - Secondary

Licenses and Certifications

ISO 13485 Training Preferred

ISO 14971 Training Preferred

IEC 62366 Training Preferred

IEC 62304 Training Preferred

Language Skills

Fluent English; excellent verbal and written communication skills

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Alcon is an Equal Opportunity Employer and takes pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity, marital status, disability, or any other reason.