In this role, you will develop new products, redesign existing products, and perform research and testing on product concepts in the medical products industry (regulated environment such as ISO 13485). In addition, you will be responsible for organizing, implementing, and maintaining an organized Design History File (DHF) documentation process, including a wide array of design verification testing and reporting for new products as well as legacy products.
Key Responsibilities:
Work on multiple R&D projects through all phases from initiation and planning through execution, monitoring, control, and closure, while following company and customer protocols and standards.
Utilize project management skills of communication, presentation, time management, organization, and planning to successfully achieve project goals, objectives, budgets, and schedules.
Initiate, implement, and maintain an organized Design History File (DHF) documentation process for successful reporting, including Risk Management, Design Input, Design Output, Design V&V protocols and reports, Design Reviews, Design changes, aging studies, transportation and storage testing, and materials relevant to design transfer to manufacturing
Matrix manages and/or cooperate with a variety of departments, functions, levels, contractors, vendors, customers, as well as global sites within the company, including marketing, QA, RA, operations, production engineering, and other internal teams
Prepare and deliver weekly and monthly progress reports/presentations to management, client, and core team.
Identify in advance, communicate, and troubleshoot process, material, equipment, or manpower issues that may hinder project flow.
Take initiatives in continuous improvement and CAPA processes.
Ensure compliance with customer specifications, quality standards, regulatory requirements, company work rules, procedures, and safety requirements.
Support Business Development in pursuit of new opportunities.
Create and organize Design V&V protocols and reports, and coordinate and execute the product qualification testing (Design Verification and Validation), aging studies, transportation, and storage testing (working with internal and external labs).
Create and edit design documents supporting technical assessment, testing reports and regulatory submissions, working with internal and external labs to validate the results
Ensure the readiness of internal and/or external audits
Understand international standards and derive applicable outcomes such as requirements or tests.
