Medical Simulation Engineer

4 days ago

Cork, Cork, Ireland Stryker Group Full time
Job Description:

The Anatomical Simulation Engineer performs and documents device and instrument simulations related to new product development of orthopedic implants. The role applies knowledge of simulation, biomechanics, and engineering principles to evaluate product safety and performance as well as compliance with medical device regulations.

Responsibilities:

  • Perform simulations for design verification and validation of medical devices, including analyses using SOMA database and tools, structural FEA, MRI, CFD, Musculoskeletal modeling, or other simulation disciplines.
  • Develop or adapt simulation models to fit product evaluation needs and create standard operating procedures under minimal supervision.
  • Support problem solving, root cause analysis, identify potential solutions, and evaluate them against requirements.
  • Conduct research and studies to support product design under minimal supervision.
  • Act as a subject matter expert for qualification and validation activities related to general simulation team operations.
  • Provide guidance and mentorship to Project Engineers, Technicians, and Interns on simulation-related topics.
  • Collaborate with stakeholders to prepare, perform analyses, and provide guidance to better interpret simulation results and validate by collaborating with different stakeholders.
  • Verify and validate simulation models and software tools through rigorous credibility assessment in collaboration with other stakeholders from test engineering and simulation customers.
  • Consult the team in utilizing CAD software packages and requirements needed for performing simulations.
  • Partner with project teams to foster the use of simulation to design safer and higher-performance devices while reducing time and cost.

Business Objectives:

  • Understand the product's intended use, function, and clinical procedures.
  • Take ownership of planning simulation tasks for projects and manage simulation campaigns.
  • Coordinate and take ownership of simulation tasks with external partners and assure quality execution of the tasks.

Regulatory Compliance:

  • Understand fundamental industry standards and testing and simulation strategies which align with regulatory requirements.
  • Ensure proper documentation, presentation, and traceability of executed simulations.
  • Learn relevant Design Control procedures including Simulation, R&D, and Biomechanics procedures and gain an understanding of risk management per the Quality Management System.
  • Become familiar with standardized design verification norms per ASTM/ISO as well as relevant FDA/regulatory guidance.
  • Understand and champion good practices and compliance.

General Responsibilities:

  • Work with R&D, Product Development, Quality, Manufacturing, Regulatory, Clinical, Marketing, and Project Management to ensure project success under minimal supervision.
  • Learn procedures, policies, processes, systems, and relevant technology.
  • Demonstrate ownership and integrity of work.
  • Build stable relationships.
  • Contribute to projects as a team member.

Required Skills:

  • Fundamental knowledge and understanding of corresponding simulation disciplines, e.g., SOMA database and tools, structural FEA, MRI, CFD, Musculoskeletal modeling, or other simulation disciplines.
  • Experience in CAD software packages.
  • Basic knowledge of analytical tools and statistical methods.
  • Ability to communicate plans and technical information to team members.

PREFERRED SKILLS / ENGINEERING TOOLS:

  • Familiarity with corresponding regulatory requirements, FDA, EU MDR, ISO, ASME, and ASTM.
  • Familiarity with design optimization, sensitivity analysis, model validation, and statistics.
  • Familiarity with applied knowledge of preclinical testing requirements for medical devices according to ISO, FDA, MDR, and ASTM guidelines.

Education Requirements:

  • Bachelor or Master of Science or PhD in Engineering, Biomedical Engineering, or similar.
  • 0+ years of work experience.
  • Fluent in English.
  • MS Office.

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