2mo
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Device Assembly & Packaging Engineer
Fishers, Indiana, United States
OnsiteFull Time
Bachelor’s in science, engineering or packaging; experience in pharmaceutical packaging or combination product development; global product launches; regulatory device requirements; Technical Transfer experience; Master’s preferred.
1mo
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Quality Engineer II
Westfield, Indiana, United States
$61k-$123k/yr OnsiteFull Time
2+ YOEBachelor’s degree in engineering; 2-5 years quality experience; medical device experience preferred.
2w
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Engineer, Process
Noblesville, Indiana, United States
OnsiteFull Time
3+ YOEBachelors in engineering, 3+ years relevant experience, medical device experience preferred, knowledge of plastics and validation (IQ/OQ/PQ), familiarity with cGMP/ISO, DOE/FMEA, and strong English communication.
Agile, Movex, Scrum Process, FMEA, DOE, cGMP, ISO
1mo
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Manufacturing Engineer
Indianapolis, Indiana, United States
$80k/yr OnsiteFull Time
5+ YOEMinimum 5 years manufacturing engineering experience in medical device production; experience with electronics/mechanical assembly, process validation, Lean/Six Sigma, APQP/PFMEA, SolidWorks, ERP/MRP, and ISO 9001/13485 compliance. ITAR requires U.S. person.
Lean Manufacturing, Six Sigma, Kaizen, 5S, SPC, MSA, CAPA, APQP, PFMEA, IQ/OQ/PQ, ERP/MRP systems, SolidWorks, Microsoft Office Suite
1w
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Validation Engineer II
Indianapolis or Carmel
FieldFull Time
3+ YOE3+ years project experience in pharmaceutical or medical device validation; knowledge of regulatory guidance (ICH, 21 CFR, GAMP5); strong technical writing, communication, and computer skills; willing to travel.
Microsoft Office, Microsoft Project, AutoCAD
1mo
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Quality Engineer II
Westfield, Indiana, United States
$61k-$123k/yr OnsiteFull Time
2+ YOEBachelor’s degree in engineering; 2-5 years quality experience; medical device preferred.
Quality tools, Document control systems, FMEAs, CAPA
1mo
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Supplier Quality Engineer
Noblesville, Indiana, United States
OnsiteFull Time
3+ YOEBS in Life Sciences or Engineering (or equivalent experience), 3+ years pharma/medical device quality experience, cGMP knowledge, experience with change control, auditing, corrective actions, statistical tools, and Microsoft Office.
Microsoft Office
1mo
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AV Conference Services Engineer
Zionsville, Indiana, United States
OnsiteFull Time
5+ YOE5+ years engineering enterprise AV and conferencing environments with deep expertise in Microsoft Teams Rooms and Zoom Rooms, experience with Poly/Yealink/Logitech/Crestron/Extron, DSPs, device management, networking, PowerShell, and event support.
Microsoft Teams Rooms, Zoom Rooms, Poly, Yealink, Logitech, Crestron, Extron, Biamp, QSC, Shure, Microsoft Teams Rooms Pro Management, Zoom Device Management, Microsoft Teams Admin Center, Microsoft Intune, vMix, Wirecast, OBS, PowerShell, Microsoft Teams Live Events, Zoom Events, Zoom Webinars, Zoom Phone
2w
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Project Engineer, Advanced Manufacturing
Noblesville, Indiana, United States
OnsiteFull Time
6+ YOEBachelor's degree and 6+ years relevant experience, 5 years automation project management and medical device experience; strong validation and regulatory knowledge; English proficiency; Spanish preferred.
PLCs, robotics, vision systems, motion control, MES, SCADA, IIoT
3w
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Software Test Automation Engineer II – Mobile
Carmel, Indiana, United States
OnsiteFull Time
2+ YOEBachelor's in CS/CE or related, 2 years Quality Engineering, test design and automation experience (Appium or Playwright), API/device/grid testing, CI/CD and DevOps integration, JIRA/Azure DevOps and test planning, HTML/CSS, NodeJS, Typescript, accessibility (WCAG).
Appium, Playwright, JIRA, Microsoft Azure DevOps, Microsoft Azure Test Plans, QTest, HTML, CSS, NodeJS, Typescript, jQuery, WCAG
1mo
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QA Risk Management Sr Engineer
Fishers, Indiana, United States
OnsiteFull Time
7+ YOEBachelor's degree in Engineering or Life Sciences; 7+ years in QA/risk management within GMP pharma/medical devices; strong knowledge of ICH Q9/ISO 14971/ISO 13485/21 CFR 201,211,820; experience with risk tools (FMEA, FTA, HACCP, PHA) and aseptic manufacturing.
FMEA, FTA, HACCP, PHA, ICH Q9, ISO 14971, ISO 13485, 21 CFR 820
3w
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Quality Assurance Inspector - 2nd Shift
Muncie, Indiana, United States
OnsiteFull Time
High school diploma, ability to read engineering drawings and measuring devices, experience with quality inspection and manufacturing processes preferred, MS Office proficiency, strong communication and problem-solving skills.
Microsoft Office, gauges, calipers
1mo
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Quality Assurance Manager
Westfield, Indiana, United States
$99k-$199k/yr OnsiteFull Time
8+ YOE3+ MgmtB.S. in Engineering or equivalent; 8+ years manufacturing-quality experience with 3+ years supervisory experience; strong project management, CAPA, regulatory compliance, and people leadership skills. Medical device and Six Sigma/ASQ credentials preferred.