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Alcon

1mo ago

  • Job
    Full-time
    Junior Level
  • Engineering
    Design
  • Bangalore
  • Quick Apply

AI generated summary

  • You need a Bachelor’s in engineering, 2 years in medical device design control, proficiency in Polarion, and strong analytical and communication skills. ISO 13485, 14971, and 62366 training preferred.
  • You will assist in digitizing requirements and risk management processes, ensure compliance, manage documentation, use Polarion software, support training, and drive process improvements.

Requirements

  • 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.
  • ISO 13485 Training Preferred
  • ISO 14971 Training Preferred
  • IEC 62366 Training Preferred
  • Fluent English; excellent verbal and written communication skills

Responsibilities

  • Assist the transformation of Requirements, Standards 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.

FAQs

What is the primary focus of the Associate position?

The primary focus of the Associate position is to assist in transforming and uplifting the Requirements, Standards, and Risk management processes from paper-based to digital formats, specifically in the context of Design Control for Medical Devices.

What qualifications are required for the Associate role?

Candidates must have a Bachelor’s degree in engineering, Systems Engineering, or a related field, along with a minimum of 2 years of experience in Design Control of Medical Devices.

Is experience with specific software tools required for this position?

Yes, proficiency with Polarion or similar requirements management software tools is required, as well as familiarity with Teamcenter PLM tools.

What kind of teams will the Associate be collaborating with?

The Associate will collaborate with cross-functional teams to drive harmonization and application of systems engineering principles and ensure seamless implementation of digitized processes.

Is there a preferred experience level for this job?

Yes, a preferred experience level includes more than 2 years associated with complex medical device design requirements and related standards.

What kind of training or support will be provided to team members?

The Associate will provide support and/or training to team members on the use of digitized tools and processes.

What personal effectiveness competencies are expected for this role?

The role expects competencies in Project Excellence, Continuous Learning, Digital and Technology Savvy, Operational Excellence, Breakthrough Analysis, and some Organizational Savvy.

Are there specific certifications that would be advantageous for this position?

Yes, ISO 13485 Training, ISO 14971 Training, and IEC 62366 Training are preferred certifications for the role.

What language skills are necessary for the Associate position?

Fluency in English, with excellent verbal and written communication skills, is necessary for the Associate position.

Where is the location of the job?

The job location is in Hebbal, Bangalore.

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Alcon

Manufacturing & Electronics
Industry
10,001+
Employees
1945
Founded Year

Mission & Purpose

Alcon helps people see brilliantly. As the global leader in eye care with a heritage spanning over 75 years, we offer the broadest portfolio of products to enhance sight and improve people’s lives. Our Surgical and Vision Care products touch the lives of more than 260 million people in over 140 countries each year living with conditions like cataracts, glaucoma, retinal diseases and refractive errors. Our more than 25,000 associates are enhancing the quality of life through innovative products, partnerships with Eye Care Professionals and programs that advance access to quality eye care.