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Job Details

Mechanical Engineer

  2025-09-04     Fortive Corporation     Irvine,CA  
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:

Bachelor's 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.

Fortive Corporation Overview

Fortive's essential technology makes the world safer and more productive. We accelerate transformation in high-impact fields like workplace safety, build environments, and healthcare.

We are a global industrial technology innovator with a startup spirit. Our forward-looking companies lead the way in healthcare sterilization, industrial safety, predictive maintenance, and other mission-critical solutions. We're a force for progress, working alongside our customers and partners to solve challenges on a global scale, from workplace safety in the most demanding conditions to advanced technologies that help providers focus on exceptional patient care.

We are a diverse team 10,000 strong, united by a dynamic, inclusive culture and energized by limitless learning and growth. We use the proven Fortive Business System (FBS) to accelerate our positive impact.

At Fortive, we believe in you. We believe in your potential-your ability to learn, grow, and make a difference.

At Fortive, we believe in us. We believe in the power of people working together to solve problems no one could solve alone.

At Fortive, we believe in growth. We're honest about what's working and what isn't, and we never stop improving and innovating.

Fortive: For you, for us, for growth.

About Advanced Sterilization Products

ASP is a leading global provider of innovative sterilization and disinfection solutions, and a pioneer of low-temperature hydrogen peroxide sterilization technology.ASP's mission is to protect patients during their most critical moments. We support healthcare facilities in the fight to protect patients against hospital acquired infections, which are a leading cause of morbidity and mortality. ASP's products, which are sold globally, include the STERRAD system for sterilizing instruments and the EVOTECH and ENDOCLENS systems for endoscope reprocessing and cleaning.

We Are an Equal Opportunity Employer. Fortive Corporation and all Fortive Companies are proud to be equal opportunity employers. We value and encourage diversity and solicit applications from all qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity or expression, or other characteristics protected by law. Fortive and all Fortive Companies are also committed to providing reasonable accommodations for applicants with disabilities. Individuals who need a reasonable accommodation because of a disability for any part of the employment application process, please contact us at ...@fortive.com.

Pay Range

The salary range for this position (in local currency) is 52,200.00 - 96,900.00

The salary range for this position (in local currency) is 52,200.00 - 96,900.00

We are an Equal Opportunity Employer

Fortive Corporation and all Fortive Companies are proud to be equal opportunity employers. We value and encourage diversity and solicit applications from all qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity or expression, or other characteristics protected by law. Fortive and all Fortive Companies are also committed to providing reasonable accommodations for applicants with disabilities. Individuals who need a reasonable accommodation because of a disability for any part of the employment application process, please contact us at ...@fortive.com.


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