Rotate Device

Job Openings

Senior Scientist, Biomedical Research

Role
Research & Development
Location

Irvine, CA

USA
Job Description

This position is responsible for achieving business and operational objectives as determined by Director of Biomedical Research Team. The personnel in this position needs to achieve all aspects of the project such as planning, coordinating, and managing activities while collaborating cross functionally with global teams to ensure timely delivery of key agreed upon technical specification and milestones with high quality and within budget.

 

Key Duties and Responsibilities

  • Lead activities related to biocompatibility assessment for several pipelines and existing products, encompassing all aspects of the project ranging from technical documentation, risk and impact assessments of tests/standards, validation assessment of changes and vendor management
  • Actively involve in biocompatibility related strategy, alternative pathways, approaches to risk assessment and mitigation
  • Execute and finalize protocols, reports and other technical documentations for biocompatibility studies
  • Collaborate with internal customers and external vendors to achieve alignment, discuss paths forward and spearhead activities to support biocompatibility related activities including testing
  • Review global regulatory requirements to assure all biocompatibility studies and documents are in alignment with current global standards
  • Develop strategies and execute studies (internal or external) to support product claims, marketing claims etc. to improve competitiveness of products in global markets
  • Support regulatory submissions globally as needed
  • Identify and communicate with existing and new vendors
  • Contribute, plan, co-ordinate activities and discussion specific but not limited to testing, sample preparation, shipment, tracking etc.
  • Other duties as assigned by the the Head of Biomedical Engineering which may include assignments to support and work closely with other functions/departments within and across the organization

 

Experience

  • At least 3 years’ experience in biomedical research in medical device with a focus on ISO 11979-5 and 10993 standards and testing
  • A familiarity of risk, impact and validation assessments
  • Exposure and experience in IOL industry is preferred although not necessary

 

Education

  • Bachelor’s degree in science and engineering or related fields. Master's degree or PhD is preferred

 

Skills

  • Adept in ISO 11979-5 and 10993 series of standards
  • Creative with an ability to continuously challenge the status quo to find creative solution to existing problem
  • Continue to learn and develop modern technology and innovation
  • Analytical, detailed oriented and ability to deliver projects of high quality on time within budget and scope
  • Excellent verbal and written communication skills in technical and non-technical areas
  • Ability to multi-task in a fast pace environment

 

Travel Requirements

  • 10-20%
  • 3-4 overseas assignment possible

 

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We regret to inform you that only shortlisted applicants will be notified. Thank you for your kind understanding.

Apply Now or E-Mail your resume to hso-ghq-hr@hoya.com; subject “Application for 'Job Title'”. Thank you!