The Role
Design and Process Development Principal Engineer will lead the design, development, and process optimization of innovative class 3 products. This role requires a strong technical background in biomedical engineering, materials science, or mechanical engineering, combined with extensive experience in product development, process engineering, and cross-functional team leadership. The Principal Engineer will ensure that products meet clinical needs, regulatory standards, and quality requirements while driving continuous improvement in design and manufacturing processes
Job Responsibilities
Product Design & Development
* Collaborate with the design and development of heart valve devices, including conceptualization, prototyping, and validation.
* Conduct risk assessments, design reviews, and failure mode and effects analyses (FMEA) to ensure robust product development.
Process Development & Optimization
* Develop and optimize manufacturing processes for heart valve products, ensuring consistency, quality, and cost-effectiveness.
* Establish and refine process parameters, controls, and documentation to ensure reliable and scalable production.
* Work closely with suppliers and manufacturing teams to develop and qualify materials and components.
Project Management
* Develop and manage project plans, timelines, budgets, and resources to meet project goals
* Communicate project progress, challenges, and solutions to stakeholders and executive management.
CI & Innovation
* Drive continuous improvement in product design, process development, and manufacturing practices.
* Drive specification changes to improve process capability and scale-up efforts.
* Participate in technical conferences, workshops, and publications to promote company expertise and leadership in the field.
Key Skills
* Experienced with Heart Valve Design or Stent
* Expertise in CAD software (e.g., SolidWorks), Finite Element Analysis (FEA), and other engineering tools.
* Demonstrated experience with process validation, statistical analysis, and quality control methodologies.
* Strong investigation and problem-solving skills.
* Knowledge of and experience in compliance with GMP and regulatory procedural standards in a medical device environment.
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