Fortive

Fortive

Sr Design Quality Engineer (Consumables)

Irvine, CA, United States · Senior

Sponsorship not specified$16k-$30kDetected 15 days ago
StatisticsExcelFDA RegulatoryMedical DevicesExperimental DesignCommunicationMicrosoft Office

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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.

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H-1B wage level

the lottery is wage-weighted — each level is one more entry

Level I · 1×
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 (Biology, Microbiology, Chemistry, etc.) 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 (Biology, Microbiology, Chemistry, etc.) 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.