Location: Dubuque, IA
Wage: Commensurate based on skill set, knowledge and previous work history.
We are partnering with a local Dubuque Manufacturer who is seeking an experienced medical device Engineering Manager to join their team . The Engineering Manager is responsible for managing engineering staff and approving new products and design changes in accordance with customer needs and regulatory requirements. The Engineering Manager is also responsible for assisting in customer complaint investigations and initiating corrective / preventative action.
WHAT YOU GET TO DO
Supervises Product Engineer
Manages customer product inquiries, product changes, and new product development
Develops policies 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
WHAT WE WANT FROM YOU
Education – BS Engineering in Mechanical / Industrial field
Experience – 4+ years of experience directly in Medical Device Engineering
Microsoft Office & Solidworks experience required.
Successful people management, leadership, and delegation experience preferred
Professional working experience and knowledge in Lean Methodologies (Kaizen, 5 Why's, etc)
Understand FDA Quality System, ISO 13485 and ISO 9001 regulations
If interested in learning more, please submit a copy of your professional resume and salary requirements to Amanda Saylor:
Sedona Staffing Services is an Equal Opportunity Employer.