Engineer III,R+D Quality

Overview

Lead quality initiatives for medical device product development across NPD projects

Key Responsibilities

• quality management
• fmea
• threat modeling
• six sigma
• documentation
• risk management

Tasks

-Plans, leads, and manages quality deliverables on new product development (NPD) projects in accordance with regulatory standards ISO9001:2015, ISO13485:2016, ISO14971, FDA, CSA, and EU MDR regulations. -Applies advanced tools and methods to solve complex problems. Tackles technical challenges and contributes to troubleshooting effort. -Applies domain expertise to the application and advancement of engineering methods and tools. Leads the application of six sigma techniques and drives continuous process improvement. -Facilitates the design and process failure mode and effects analysis (FMEA) process. -Assists with the creation of the reliability predictions for projects with recommended testing profiles and analyzes test results. -Leads the creation of threat models and cybersecurity risk assessments. -Provides leadership, coaching, and/or mentoring to level I and level II engineers. -Supports internal and external quality system audits. -Creates, reviews, and approves documentation related to the engineering Product Realization Process (PRP). Documentation includes, but is not limited to, change requests, engineering orders, product and component test specifications and design records. -Leads all risk management processes and creates risk management documentation for (NPD) projects. -Mentors engineer I & II teammates, focusing on technical skills, collaboration skills, and cultural competencies. -Leads the creation and maintenance of the products Usability Engineering Files, provides misuse cases involving use error and assesses the impact. -Collaborates with cross-functional teams to align decisions with business goals. -Leads site-based quality department initiatives as a subject matter expert (SME).

Requirements

• microsoft office
• minitab
• analytical tools
• communication skills
• medical device
• system design

What You Bring

-Mastery of software programs - Microsoft Word, PowerPoint, Excel, Project, Minitab -Ability to apply advanced analytical tools and methods to solve complex problems -Strong written and verbal communication skills -Experience in the medical device industry and understanding of medical device quality systems and applications is desired. -Ability to lead the design of complex systems and identify new technological opportunities

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About Midmark Corporation

-Designs and manufactures medical equipment that enhances the patient care experience. -Offers a wide range of products including examination tables, diagnostic equipment, and sterilization systems. -Serves various healthcare facilities like hospitals, clinics, and dental offices with tailored solutions. -Known for innovative products that improve workflows and patient outcomes in medical environments. -Has a global presence with operations extending across multiple countries and healthcare markets. -Consistently focused on integrating cutting-edge technology into their products for efficiency and safety.

Sector Specialisms