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Senior Associate

2+ years
Not Disclosed
10 Dec. 25, 2024
Job Description
Job Type: Full Time Education: BE/BCS Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Senior Associate – Design Control of Medical Devices at Alcon

Alcon is seeking a Senior Associate to drive the transformation of our Requirements and Risk management processes. This role will involve working with key tools like Polarion and Teamcenter PLM to digitize the requirements and risk management system, ensuring compliance with medical device standards and regulations.

Key Responsibilities:

  • Transformation of Processes: Lead the transition from paper-based to digital Requirements and Risk management processes.
  • Design Control Compliance: Ensure adherence to Design Control regulations and standards for medical devices.
  • Requirements Management: Use Polarion or similar tools for managing and tracking requirements, ensuring alignment with product development.
  • Collaboration: Work closely with cross-functional teams to integrate systems engineering principles and drive harmonization across departments.
  • Documentation: Maintain and develop documentation related to requirements, standards, and risk management.
  • Support and Training: Provide training and guidance on the use of digitized tools and processes, helping to ensure smooth adoption.
  • Process Improvements: Identify opportunities for efficiency improvements within the Requirements and Risk management process.

Qualifications:

  • Education: Bachelor’s degree in Engineering, Systems Engineering, or a related field.
  • Experience:
    • Minimum 2 years in Design Control for medical devices, with preferred experience in complex medical device design (e.g., SIMD devices).
    • Experience with Polarion or similar requirements management software is required.
    • Strong background in systems engineering, including modeling principles and practices.
  • Skills:
    • Strong analytical and problem-solving abilities.
    • Excellent communication skills and the ability to collaborate across teams.
    • Project Management experience with the ability to handle multiple tasks.
    • Proficiency in Excel and other data visualization tools.
    • Knowledge of ISO 13485, ISO 14971, and IEC 62366 is preferred.

Preferred Knowledge:

  • Working knowledge of Subversion (SVN) version control and ReqIF formats.
  • Familiarity with state-of-the-art standard assessments.
  • ISO 13485, ISO 14971, and IEC 62366 training are preferred.

Personal Competencies:

  • Project Excellence: Intermediate
  • Continuous Learning: Intermediate
  • Digital & Technology Savvy: Intermediate
  • Operational Excellence: Intermediate
  • Breakthrough Analysis: Intermediate

Languages:

  • Fluent in English (verbal and written communication)

Internal Applicants:

If you are an active employee or contingent worker at Alcon, please apply through the appropriate internal career site:

Equal Opportunity Employer:

Alcon is committed to maintaining a diverse environment and does not discriminate in recruitment, hiring, training, promotion, or other employment practices based on race, color, religion, gender, national origin, age, sexual orientation, gender identity, marital status, disability, or any other reason.


This role offers an exciting opportunity for professionals with expertise in medical device design control to lead transformative changes and drive digitization within a globally recognized company.