Engineering Manager - Medical Devices

Job Location: 
Dubuque, IA

Are you ready for a new challenge, and motivated to make an impact at a leading, global, full-service medical device manufacturer with a reputation for developing products of quality and precision for nearly 50 years? If you would like to grow your career and fill an important position, then you could be what our client is looking for in their next Engineering Manager-Medical Devices.  You will be responsible for approving new products and design changes in accordance with customer needs and regulatory requirements, as well as assisting in customer complaint investigations and initiating corrective/preventative action. Strong experience with FDA remediation and recall activities within large pharmaceutical/medical device industry is highly preferred. This is an excellent opportunity with a respected and stable company that offers a competitive compensation package.  If this is for you or someone you know, please forward a current resume to


Responsibilities – Engineering Manager

Provides leadership to Product Engineers and manages assignment of responsibilities

Manages customer product inquiries, product changes, and new product development

Develops procedures to be compliant with regulatory requirements

Reviews and approves Document Change Orders (DCO)

Evaluates design or manufacturing problems and initiates process improvements

Writes process validation protocols and results

Assists in investigating and answering customer complaints

Reviews and approves part specifications

Approves new drawings and BOM’s

Estimates and initiates solutions to reduce product costs

Participates in maintaining the company’s quality system and adheres to standard operating procedures as applicable


Requirements – Engineering Manager

Bachelor of Science degree in Engineering or related degree with at least 7 years work experience in Engineering

Supervision experience preferred

FDA remediation and recall exposure experience

Understanding of ISO 13485 and FDA medical device regulations required

Excellent written and oral communication skills required

Possess ability to effectively delegate, motivate, and manage all functions of the engineering department

Strong leadership skills to supervise engineering personnel

Ability to use Microsoft Office required; CAD preferred


Recruiter Name: 
Tim Borop
Recruiter Phone: 
(262) 886-8000 ext. 218
Manufacturing & Engineering

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