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Remote Sr Biomedical Engineer

Saint Paul, MN 55112

Posted: 08/21/2023 Employment Type: Contract Job Category: Engineering Job Number: 579735 Is job remote?: Yes Country: United States

Job Description

  1. Can you please confirm your top 3 skills sets required? Develop biocompatibility strategy, write biological risk assessments and executing testing, responding to deficiencies
  2. What is your target years of experience? Minimum 2 years, Ideal 5 years

Responsibilities may include the following and other duties may be assigned.
  • Develop biocompatibility strategies and prepare biological evaluation plan in consideration of gaps in materials, design and process to achieve optimal solutions that satisfy timeline, cost and technical requirements as they relate to biological safety
  • Coordinates and facilitates biocompatibility testing of materials and designs in accordance with FDA requirements, internal SOPs and standards
  • Liaise with internal resources (design, regulatory, quality, clinical and manufacturing) and external resources, developing and coordinating test strategies with Contract Research Organizations (CROs) to ensure appropriate planning and execution of required testing
  • Perform gap assessments of products by reviewing legacy documentation and evaluating device BOMs to determine the applicability of test data to ISO 10993 standard.
  • Write biological risk assessments to ensure all the relevant end points mentioned in ISO 10993 are met.
  • Analyze, interpret, and draw conclusions from biocompatibility testing, including, but not limited to, extractable and leachable chemical characterization and biological evaluations
  • Develop and deliver regulatory submission responses to biocompatibility related questions
  • Influence organization excellence by recommending approaches, procedures, and work aids as they relate to biocompatibility, in compliance with applicable global regulatory requirements
  • Participate in the analysis of technical issues and the development of recommendations for project decisions and actions

SPECIALIST CAREER STREAM: Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University).

Autonomy: Seasoned individual contributor. Works independently under limited supervision to determine and develop approach to solutions. Coaches and reviews the work of lower level specialists; may manage projects / processes.

Organizational Impact: May be responsible for entire projects or processes within job area. Contributes to the completion of work group objectives, through building relationships and consensus to reach agreements on assignments.

Innovation and Complexity: Problems and issues faced are difficult, and may require understanding of multiple issues, job areas or specialties . Makes improvements of processes, systems or products to enhance performance of the job area. Analysis provided is indepth in nature and often provides recommendations on process improvements.

Communication and Influence: Communicates with senior internal and external customers and vendors. Exchange information of facts, statuses, ideas and issues to achieve objective, and influence decisionmaking.

Leadership and Talent Management: May provide guidance, coaching and training to other employees within job area. May manage projects, requiring delegation of work and review of others' work product .

Required Knowledge and Experience: Requires advanced knowledge of job area combining breadth and depth, typically obtained through advanced education combined with experience. May have practical knowledge of project management. Requires a University Degree and minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience.

?CO and NY candidates may not be considered
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