Associate II, Research & Development Process & Product Design (T)

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:

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

Skills and Knowledge:

• Design Control and Risk Management
• STEAM Applied Science Technology Engineering Arts and Math
• Regulations and Guidelines
• Proficiency with Teamcenter PLM or similar product lifecycle management tools
• Preferred: Polarion or similar requirements management tools
• Microsoft Office suite (i.e. Word Excel PowerPoint Visio)
• Technical/Scientific Writing in English in a regulated environment
• Verbal English communication skill (in a remote environment)
• Preferred: Project Management experience

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 Preferred

ISO 14971 TrainingPreferred

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.