We anticipate the application window for this opening will close on - 4 Jul 2025

 

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.

A Day in the Life

We are seeking a motivated individual to join the Operations Engineering Team to support day to day manufacturing operations. The candidate will work closely with various support groups on implementing manufacturing process/equipment improvements as well as mitigating quality defects and manufacturing downtime.

Manufacturing Engineer II
 Location: Onsite, Boulder, Colorado  

The Manufacturing engineering position will focus on supporting sustaining optimization projects and qualifications.  Responsibilities of this position will include project management, validation procedures, manufacturing job instructions, execution of the validation, compilation of reports, coordinating of tasks and creating engineering change orders.  The role will interact directly with the manufacturing operators, supplier quality engineers, operations quality engineers, and design engineers to ensure proper qualification plan is followed.  

• Responsibilities may include the following and other duties may be assigned. 
• Develops and executes validation strategy of various changes including scrap reduction, fixture improvements, supplier changes, and equipment optimization 
• Develops manufacturing processes that are applicable to statistical process control and may develop those techniques. 
• Designs manufacturing processes, procedures and production layouts for assemblies, equipment installation, processing, machining and material handling. 
• Adapts machine or equipment design to factory and production conditions. 
• May incorporate inspection and test requirements into the production plan. 
• Inspects performance of machinery, equipment, and tools to verify their efficiency, and investigates and initiates corrective action of problems and deficiencies to ensure product quality 
• Provides guidance regarding design concepts and specification requirements to best utilize equipment and manufacturing techniques. 
• Ensures processes and procedures are in compliance with regulations.  

 

Additional Responsibilities 

• Ensures reliability, develops technical specifications for production, analyzes configuration and processing solutions, and tests product conformance to specifications. 
• Collaborates with research, design, development, and testing for product improvement projects. 

 

Knowledge/Skills/Abilities: 

• Mechanical aptitude. 
• Strong computer skills, including Microsoft Word, Microsoft Excel, Microsoft Project, Minitab, etc. 
• Familiarity and expertise with statistics, ability to analyze data, interpret results and write technical reports. 
• Knowledge of GMP and ISO regulations (Design Controls). 
• Comply with applicable FDA and international regulatory laws/standards and the Medtronic Code of Conduct 
• Must be able to work in a dynamic environment with little supervision or daily direction 
• Strong, team-oriented professional with good interpersonal skills and project management experience. 

 

Must Have: Minimum Requirements 

  

• Bachelors degree required 
• Minimum of 2 years of relevant experience, or advanced degree with 0 years of experience 

 

Nice to Have 

• Electrical, Mechanical, or Electromechanical degree 
• Medical Device experience 
• Experience with equipment development and process validation (IQ/OQ/PQ) 
• Small tooling design and development 
• Engineering experience with medical devices