Description

Design and build in-house manufacturing equipment from concept to implementation.
Create effective design solutions of mechanical assemblies
from simple fixturing to more complex assembly for
automation equipment.
Iterate rapidly by prototyping, testing, and examining
product designs using engineering methods and
techniques, including computer simulation and physical models
Ensure manufacturing equipment designs meet functional, safety, ergonomic,
documentation, and validation requirements.
Create and manage project plans including schedules, budgets, and stakeholder
updates.
Develop documentation for equipment including specifications, assembly instructions,
maintenance, and calibration procedures.
Create and execute protocol documentation for equipment DQ, IQ, OQ, PQ validations.
Conduct effective design reviews of new equipment at all stages of development.
Provide equipment-related technical support for on-going production operation and
expansion.
Establish and manage external resources (contractors, system integrators, vendors) in
the planning and execution of equipment projects including duplication activities.
Support other equipment-related operations and duties as required

Qualifications
Required Skills and Experience
Minimum BSME or similar.
Minimum 3 years experience designing and developing Automated manufacturing
equipment.
Self-motivated, works well with others in a team environment.
Proficiency with CAD (SolidWorks highly preferred): designing parts with complex
geometry, creating assemblies and creating detailed manufacturing drawings
Comfortable operating machine shop, measurement, and test equipment
Mechanical design and exploration skills, including statics, dynamics, and strength of
materials, including stress analysis, fatigue, and thermal
Experience in integration of mechatronics components such as sensors, motors,
pneumatics, and motion and vision control components.
Experience troubleshooting and repair of manufacturing equipment.
Experience developing equipment qualification, calibration
and PM procedures and practices.
Required Education and Training
Minimum BSME Mechanical or Mechatronics engineering
with minimum of 5 years related experience.
Experience with enterprise software (e.g. Agile document control, Confluence, Polarion,
Windchill, etc)
Prior experience working with PLM systems (Agile preferred), SAP applications, including
ECO creation, origination of equipment specification, test protocols, BOM, and work
instructions.
Preferred Skills and Experience
Excellent understanding of tolerance analysis and statistical methods. Fluency in ASME
Y14.5 GD&T and tolerance stack analysis
MSME (or equivalent) with minimum 6 plus years prior experience.
Structured Problem Solving. Rational thinking and root cause analysis capability.
Experience working in a medical device or other regulated quality systems

Key Skills

Education

Bachelor's degree