Mechanical Engineer
New Today
Mechanical Engineer
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 stronger, safer, and smarter. We accelerate transformation across a broad range of applications including environmental, health and safety compliance, industrial condition monitoring, next-generation product design, and healthcare safety solutions.
We are a global industrial technology innovator with a startup spirit. Our forward-looking companies lead the way in software-powered workflow solutions, data-driven intelligence, AI-powered automation, and other disruptive technologies. 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 groundbreaking sustainability solutions.
We are a diverse team 17,000 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 potentialyour 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 applyassistance@fortive.com.
Pay Range: The salary range for this position (in local currency) is 52,200.00 - 96,900.00
- Location:
- Irvine
We found some similar jobs based on your search
-
New Today
Thermal Mechanical Engineer
-
Irvine
POSITION DESCRIPTION SUMMARY Netlist is looking for an exceptional Thermal/Mechanical Engineer to develop thermal solutions for memory and storage products for sale to top tier OEMs/ODMs and Hyperscalar customers. QUALIFICATIONS Essential Duties a...
More Details -
-
New Today
Thermal Mechanical Engineer
-
Irvine, CA, United States
- Architecture And Engineering Occupations
POSITION DESCRIPTION SUMMARY Netlist is looking for an exceptional Thermal/Mechanical Engineer to develop thermal solutions for memory and storage products for sale to top tier OEMs/ODMs and Hyperscalar customers. QUALIFICATIONS Essential Duties a...
More Details -
-
New Today
Electro-Mechanical Actuation Modeling and Controls Engineer
-
Costa Mesa, CA
-
$100
- Engineering
Anduril Industries is a defense technology company with a mission to transform U.S. and allied military capabilities with advanced technology. By bringing the expertise, technology, and business model of the 21st century’s most innovative companies t...
More Details -
-
New Today
Lighting Mechanical Engineer
-
Irvine
About Rivian Rivian is on a mission to keep the world adventurous forever. This goes for the emissions-free Electric Adventure Vehicles we build, and the curious, courageous souls we seek to attract. As a company, we constantly challenge what's pos...
More Details -
-
New Today
Mechanical Engineer
-
Irvine
Mechanical Engineer 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 steril...
More Details -
-
New Yesterday
Sr. Mechanical Engineer - Healthcare
-
Irvine
Are you a Senior Level Mechanical Engineer with 10 + years of experience looking to grow your career? Our client is an award-winning engineering firm named "Best Place to Work" for the past 15 years. They have an open position for a Senior-Level Mec...
More Details -