Fortive
Sr Design Quality Engineer (Mechanical/Electrical)
Irvine, CA, United States · Senior
Sponsorship not specified$16k-$30kDetected 15 days ago
StatisticsExcelFDA RegulatoryMedical DevicesExperimental DesignCommunicationMicrosoft Office
Stay score
odds of building a lasting career here
37Risky
Cap-exempt (no lottery)0
Sponsors this role80
Entry-level history0
PERM / green-card track0
Lottery odds (Level I)39
Fits your clock70
Thin sponsorship signal and lottery-bound (~15% per draw). A low-probability bet with your clock running. Prioritize cap-exempt roles and proven entry-level sponsors first.
Lottery odds assume a STEM candidate.
Personalize to your clock →H-1B wage level
the lottery is wage-weighted — each level is one more entry
Level I$83,3871 entry
Level II$102,2532 entries
Level III$121,0983 entries
Level IV$139,9634 entries
The bottom of this range ($16,000) is below the Level I prevailing wage of $83,387. An H-1B cannot be filed below the prevailing wage, so an offer at the floor of this band could not be sponsored as posted.
DOL prevailing wage, 2026-27 wage year · Industrial Engineers (17-2112) · Los Angeles-Long Beach-Anaheim, CA. Wage level is derived by USCIS from the offered wage, occupation and worksite; the occupation shown is inferred from the job title.
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About the role
- Independently plans and executes complex projects and assignments within broad guidelines, exercising judgment based on analysis of multiple sources of information.
- Receives minimal guidance and acts as a resource for colleagues with less experience.
Responsibilities
- Owns the Risk Management process, collaborating with representatives from other functional areas to facilitate risk analyses and design control processes, reviewing and approving design verification and validation documentation.
- Performs complex technical investigations including formal NCs and CAPAs coordinating cross-functionally to ensure sound experimental design, effective analysis of multiple sources of information, appropriate risk analysis, design control, and verification and validation, and timely investigation closure.
- Acts as a resource for colleagues in risk management, design control, verification and validation, or CAPA and supports new product introduction, design changes, and post-launch activities.
- Supports and participates in cross-functional projects and may lead small projects with manageable risks and resource requirements.
- Contributes technical improvements that enhance quality systems and support business goals. Applies appropriate tools and methods (e.g. 6-Sigma, Lean, Statistical methodologies) to improve products, processes, and services.
- Participates in technical reviews, explains difficult or sensitive quality information, and works to build cross-functional consensus.
- Ensures quality control plans are commensurate with product risk and consistently followed across own and related teams.
- Supports internal, external, and third-party audits as Quality Subject Matter Expert and responds to observations in support of compliance with quality management system elements.
- Provides back-room support for third-party inspections and audits, such as Registrar, Notified Body, FDA, or customer audits.
Requirements
- Applies in-depth knowledge of quality engineering principals, relevant regulations, standards, industry best practices, and other related disciplines to assignments.
- Ability to communicate in a cross-cultural environment.
- Demonstrated proficiency in Risk Management, FMEAs, Design Control, Root Cause, and Design Verification and Validation methodologies.
Nice to have
- Bachelor's Degree in Engineering, Science, or other technical field.
- Engineering degree preferred
- At least 4 years of experience in Quality Assurance, Quality Engineering, or related field.
- Outstanding business and technical communication skills (verbal, written, presentation)..
- Experience planning and executing projects, including small projects with manageable risks and resource requirements, critical path analysis, and analytical or microbiological method validation..
- Ability to communicate in a cross-cultural environment. - Proficient in Microsoft Excel, Word, Powerpoint and other standard software..
- Strong working knowledge of FDA QSR 21 CFR 820 / ISO13485 quality system requirements and knowledge of both regulatory requirements and other compliance areas..
- Ability to work independently with minimal guidance and within broad guidelines and policies..
Compensation
- The salary range for this position (in local currency) is 101,200.00 - 169,050.00
Benefits
- Education and Experience: - Bachelor's Degree in Engineering, Science, or other technical field.
- We accelerate transformation in high-impact fields like workplace safety, build environments, and healthcare.
- Our forward-looking companies lead the way in healthcare sterilization, industrial safety, predictive maintenance, and other mission-critical solutions.
- We are a diverse team 10,000 strong, united by a dynamic, inclusive culture and energized by limitless learning and growth.
- We support healthcare facilities in the fight to protect patients against hospital acquired infections, which are a leading cause of morbidity and mortality.
- Bonus or Equity This position is also eligible for bonus as part of the total compensation package.
Company info
- We are a global industrial technology innovator with a startup spirit.
- 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.
- At Fortive, we believe in growth.
Equal opportunity
- Equal Opportunity Employer.
- equal opportunity employers.
- Individuals who need a reasonable accommodation because of a disability for any part of the employment
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This listing is sourced directly from Fortive's careers page and normalized into a canonical job model.