Manufacturing Engineer--Sustaining Engineering
Primary Location: Mesa, AZ Schedule: Full time
Travel: up to 25% Duration: 2+ years
ENEA…an environment where you can innovate.
We are seeking a Manufacturing Engineer to work on a 2+ Year LONG TERM contract working on medical devices in Mesa, AZ (East of Phoenix).
The Manufacturing Engineer is a manufacturing and process development expert leading project work related to manufacturing integration of medical devices.
This individual will be involved in all phases of product development as a key contributor representing manufacturing.
You will work with R&D to ensure designs are manufacturable, evaluate potential suppliers, and work with internal and external teams to develop and validate manufacturing processes.
Essential Duties & Responsibilities
- Process Development & Validation
- Drive efforts to design, develop, validate, and continuously improve manufacturing processes.
- Develop & define production control methods to monitor process output and establish critical supplier metrics.
- Define and coordinate the design and development of manufacturing fixturing and test equipment.
- Coordinate with R&D at suitable stages to optimize the design for manufacturing and reliability.
- Perform or direct DOE, correlation studies and apply statistical analysis for product and process improvements.
- Lead and support manufacturing development and transfers to contract manufacturers.
- Design Controls Documentation
- Provide input to the User Requirements and System Requirements Documents.
- Ensure compliance to the requirements of ISO13485 standards, FDA regulations and Good Manufacturing Practice regarding process, design and development of new and existing products.
- Supplier Evaluation & Selection
- Identify potential suppliers & perform technical evaluation for selection
- Develop the team
- Guide work & mentor junior team members
- Other duties as assigned
Job Related Qualifications/Skills
- Bachelor’s Degree in Mechanical or Electrical Engineering or other relevant engineering discipline REQUIRED
Professional Experience Required:
- 3-7 years of related design and manufacturing experience in the medical device industry ***HARD REQUIREMENT—MUST HAVE PREVIOUS MED DEVICE EXPERIENCE**
- Experience in manufacturing and assembly process development and validation (IQ, OQ, PQ and PPQ)
Professional Experience Preferred:
- Design Control experience including design and process verification and validation
- Injection molding, die casting, tooling experience
Knowledge, Skills, & Abilities (incl. languages)
- Thorough understanding of test method validation, GR&R, GD&T, and statistical analysis
- SolidWorks or other CAD experience
- Familiar with project management methods and tools
Knowledge of Methods
- Practical knowledge of Six Sigma methodologies. Green or Black Belt certification preferred
- Understanding and application of ISO Quality System requirements and FDA regulations
- Familiar with a variety of manufacturing processes including mechanical and electromechanical
- Ability to work effectively with internal and external teams
- Demonstrated ability to deliver results with minimal supervision
- Ability to support and direct the efforts of junior level engineering staff
Job Types: Full-time, Contract
Salary: $55.00 to $65.00 /hour
- SolidWorks or other CAD: 3 years (Required)
- Manufacturing Engineering in Medical Device Industry: 3 years (Required)
- manufacturing & assembly process development & validation: 3 years (Required)