Manufacturing Engineering Manager

Company: The Metrix Company
Location: Dubuque
Posted on: January 15, 2021

Job Description:

The Metrix Company, a medical device manufacturer, is seeking an experienced Engineering Manager to lead new product development and design change in accordance with customer needs and regulatory requirements. The Engineer Manager is also responsible for assisting in customer complaint investigations and initiating corrective / preventative action (CAPA). Other duties include:

• Provides leadership to Product Engineers and manages assignment of projects and responsibilities
• Manages customer product inquiries, product changes, and new product development process
• Develops and maintains procedures to be compliant with regulatory requirements (ISO 13485 & FDA Medical Device Regulations), including 510k submissions, product risk management, usability process, validations and post-market surveillance.
• Reviews and approves Document Change Orders (DCO), contract product specifications, work instructions, standard operating procedures, new drawings, and Bills of Material (BOM---s)
• Responsible for process validation, writing protocols, writing standard operating procedures (SOP---s), reviewing results, and initiating any corrective actions
• Assists in investigating customer complaints, developing corrective action as needed, including the review of impacts to Risk Management System
• Estimates and initiates solutions to reduce product costs, improve productivity and increase tooling/equipment capacity
  Qualified candidates must possess a Bachelor of Science degree in Engineering with at least four years of relevant work experience. Understanding of ISO quality system regulations required. Knowledge of ISO 13485 and FDA medical device regulations strongly preferred, including Risk Management and 510k submissions. Strong communication skills and computer proficiency necessary, including Microsoft Office and Solidworks. Must possess the ability to effectively delegate, motivate others, and manage all functions of the engineering department. The Metrix Company offers an excellent benefit and compensation package.
  Candidates must be authorized to work in the United States. Employer will not sponsor applicants for work visas.

Keywords: The Metrix Company, Dubuque , Manufacturing Engineering Manager, Executive , Dubuque, Iowa