Insulet Corporation

Insulet Corporation

Quality Engineer - NPI Programs

Acton, Massachusetts

Sponsorship not specified$70k-$106kDetected 25 days ago
StatisticsComplianceGMPFDA RegulatoryMedical DevicesLeadershipCommunicationCollaborationProblem SolvingRegulatory Affairs

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odds of building a lasting career here

50Sponsors, lottery-bound
Cap-exempt (no lottery)0
Sponsors this role90
Entry-level history0
PERM / green-card track0
Lottery odds (Level II)66
Fits your clock70

Sponsors, but it's cap-subject — you still face the weighted lottery (~30% per draw at Level II). Good if you win; have a cap-exempt backup on your list.

Lottery odds assume a STEM candidate.

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Employer immigration record

from this employer's Department of Labor filings

Green-card filing pattern in this occupation

Context, not a finding about this posting: of this employer's 6 green-card filings in this occupation, 100% were for a worker who already held the job.

Green-card follow-through: 85%

Of 13 labor certifications old enough to have been used, 2 expired without the employer filing the next step. Median time from filing to decision: 497 days.100% of their filings were for a worker who already held the job.Only certifications past the 180-day window are counted — recent ones cannot have expired yet.

Files H-1B transfers

5 transfer filings in the last year, covering 5 workers. Median labor-condition decision: 8 days. An employer that already files transfers is one that can take over an existing H-1B.

Sourced from Department of Labor LCA, PERM and prevailing-wage disclosure data. Employer matching is by name, so figures may be split across an employer's legal entities. Absence of a filing means none appears in our copy of the data, not that none exists.

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About the role

  • The Quality Engineer, NGP Programs is responsible for supporting quality engineering activities to facilitate early-stage product development and pilot manufacturing operations.
  • The Quality Engineer, NPI Programs plays a critical role in supporting new product development and pilot manufacturing by ensuring quality is built into products and processes from the earliest stages of development through commercialization.

Responsibilities

  • Lead quality engineering activities supporting prototype, pilot, clinical, and development manufacturing builds.
  • Develop and maintain inspection plans, control plans, procedures, work instructions, and quality standards for evolving products and manufacturing processes.
  • Define and implement inspection and test methodologies to support product development, pilot manufacturing, and release activities.
  • Ensure compliance with design controls, traceability requirements, quality systems, and product documentation throughout the development lifecycle.
  • Support Design History File (DHF) and Device History Record (DHR) compliance, lot release activities, and clinical build readiness.
  • Analyze quality and manufacturing data to identify trends, mitigate risks, and drive continuous improvement initiatives.
  • Lead investigations of nonconforming materials and products, conducting root cause analysis and implementing corrective and preventive actions (CAPA).
  • Support qualification and validation of manufacturing equipment, inspection systems, test methods, and production processes (IQ/OQ/PQ).
  • Partner with R&D and Manufacturing Engineering teams to improve product manufacturability, inspectability, reliability, and process capability.
  • Support manufacturing transfer and commercialization efforts through development of production quality controls and readiness assessments.

Requirements

  • Bachelor's degree in engineering or a related technical discipline.
  • Experience with inspection methods, metrology systems, test methods, and measurement system analysis.

Nice to have

  • Experience supporting new product development (NPD) programs.
  • Experience with design controls, risk management, and manufacturing quality initiatives.
  • Additional Information:
  • 401(k) with company match
  • The Omnipod Insulin Management System provides a unique alternative to traditional insulin delivery methods.
  • For more information, please visit insulet.com and omnipod.com.
  • We do this by hiring amazing people guided by shared values who exceed customer expectations.
  • Our continued success depends on it!

Compensation

  • Compensation & Benefits:For U.S.-based positions only, the annual base salary range for this role is $70,400.00 - $105,650.00This position may also be eligible for incentive compensation.We offer a comprehensive benefits package, including:

Company info

  • We are looking for highly motivated, performance-driven individuals to be a part of our expanding team.
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This listing is sourced directly from Insulet Corporation's careers page and normalized into a canonical job model.