Mechanical Engineer
Mechanical Engineer
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Job Description
Position Summary:
The Mechanical Engineer at Advanced Sterilization Products (ASP) will play a critical role in the design development implementation and continuous improvement of mechanical systems components and equipment used in our sterilization products and GMP-regulated manufacturing environment. This individual will support new product introduction sustaining engineering facility systems and capital projects with a focus on quality compliance and operational excellence.
Key Responsibilities:Design and develop mechanical systems and components to meet product requirements regulatory standards and safety guidelines.
Provide mechanical engineering support for manufacturing facility utilities cleanroom infrastructure and equipment.
Lead root cause analysis and corrective actions for equipment failures or process deviations.
Support the execution of capital projects including design reviews vendor selection installation and commissioning.
Partner with cross-functional teams (R&D Quality Manufacturing Facilities Automation) to drive process improvements and product enhancements.
Develop and maintain technical documentation including engineering drawings design specifications SOPs and validation protocols.
Apply FBS (Fortive Business System) tools and lean principles to improve equipment reliability reduce downtime and increase productivity.
Ensure all designs and projects are compliant with GMP FDA ISO 13485 and applicable regulatory requirements.
Required Qualifications:Bachelors degree in Mechanical Engineering or a related field.
3 years of experience in a mechanical engineering role preferably within a medical device pharmaceutical or GMP-regulated environment.
Proficient in CAD software (SolidWorks preferred) GD&T and engineering drawing standards.
Strong knowledge of mechanical systems including pneumatics hydraulics HVAC and automated equipment.
Hands-on experience with equipment installation troubleshooting and validation (IQ/OQ/PQ).
Familiarity with industry codes and standards (ASME ASTM ISO FDA).
Excellent analytical problem-solving and project management skills.
Strong communication and interpersonal abilities.
Preferred Qualifications:Experience with autoclaves and assembly manufacturing equipment.
Working knowledge of PLCs automation or controls integration is a plus.
Lean Six Sigma certification or experience applying lean tools.
Understanding of cleanroom classifications and environmental controls.
Employment Type
Full-Time
