Simulation Technology Development Lead
4 days ago
The Simulation Engineer will be responsible for performing and documenting device and instrument simulations related to new product development of orthopedic implants.
Key Responsibilities:
- Design and develop simulation models to evaluate product safety and performance.
- Collaborate with cross-functional teams to ensure simulation results meet regulatory requirements.
- Provide guidance and mentorship to junior engineers on simulation-related topics.
- Conduct research and studies to support product design.
- Act as a subject matter expert for qualification and validation activities related to general simulation team operations.
Business Expectations:
- 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 Considerations:
- 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.
- Learn procedures, policies, processes, systems, and relevant technology.
- Demonstrate ownership and integrity of work.
- Build stable relationships.
- Contribute to projects as a team member.
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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