Job Description

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 - 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 Training Preferred
IEC 62366 Training Preferred
IEC 62304 Training Preferred
Language Skills
Fluent English; excellent verbal and written communication skills
ATTENTION: Current Alcon Employee/Contingent Worker
If you are currently an active employee/contingent worker at Alcon, please click the appropriate link below to apply on the Internal Career site.
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.