18 medical device engineer jobs at 13 companies in Pendleton, IN
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Medical Quality Engineer
Shelbyville, Indiana, United States
OnsiteFull Time
5+ YOE5+ years manufacturing experience (≥3 years in medical device quality), experience with IQ/OQ/PQ validations, ISO 13485/FDA/cGMP knowledge, statistical methods/SPC, strong communication, and Microsoft Word/Excel proficiency.
Microsoft Word, Microsoft Excel
6d
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Sr. Equipment Engineer
Indianapolis, Indiana, United States
$108k-$131k/yr OnsiteFull Time
5+ YOERequires 5+ years of equipment engineering experience and a BS in Engineering. GMP, validation, project management, robotics, and biopharmaceutical or medical device experience preferred.
Robotics, Personal Protective Equipment (PPE)
2mo
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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.
6d
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Sr. Equipment Engineer
Indianapolis, Indiana, United States
$108k-$131k/yr OnsiteFull Time
5+ YOERequires 5+ years of equipment engineering experience and a BS in Engineering. GMP manufacturing, validation, project management, robotics, and biopharmaceutical or medical device experience preferred.
Robotics, Personal Protective Equipment (PPE), Electronic Health Records (EHR)
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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
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CQV Engineer
Indianapolis, Indiana, United States
$80k-$95k/yr OnsiteFull Time
2+ YOEBachelors in engineering/science or equivalent experience; 2+ years validation experience in regulated manufacturing (biotech/pharma/medical device); writing validation documents; FAT/SAT/IQ/OQ/PQ; temperature mapping; FDA and cGMP knowledge; P&ID interpretation.
1mo
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Senior Process Engineer - Electrical
Indianapolis, Indiana, United States
OnsiteFull Time
5+ YOEBachelor's in Electrical Engineering (5+ years) or Master's (2+ years); experience with PFMEA, process capability, statistical analysis, structured problem solving (Six Sigma, 5 Why, 8-D); design/change control experience for medical devices preferred.
PFMEA, Six Sigma, 5 Why, 8-D, Danaher Business System
3w
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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
6d
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IDAP MES System Engineer Tech at Lilly
Indianapolis, Indiana, United States
$65k-$158k/yr OnsiteFull Time
2+ YOEBachelor's degree in IT, computer science, computer engineering, or related field; 2+ years of MES experience; 3+ years in regulated pharmaceutical or medical device manufacturing; U.S. work authorization required.
Manufacturing Execution System (MES), Microsoft Excel, Microsoft Word, Microsoft PowerPoint, PharmaSuite, PMX, Werum PAS-X, Emerson Syncade, DeltaV, Enterprise Resource Planning (ERP), Computer System Validation (CSV), GAMP 5, 21 CFR Part 11, Annex 11
2mo
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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
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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
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Lead Software Engineer – Digital Health Platform
Indianapolis, Indiana, United States
$126k-$224k/yr HybridFull Time
7+ YOEBachelor's in CS/engineering, 7+ years delivering software across the lifecycle, 5+ years technical leadership, knowledge of medical device regulatory expectations, cloud and integration experience.
Kafka, AWS, Azure, Okta, GitHub, CI/CD, Atlassian, Jira, Confluence
1mo
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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
2w
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Global Product Manager, Urology Medical Devices
Bloomington or Indianapolis or Chicago or Louisville or Fort Wayne or Cincinnati or Winston-Salem
HybridFull Time
5+ YOECollege degree or equivalent experience, 5+ years relevant experience in product management/engineering/marketing, fluency in AI and data concepts, demonstrated project leadership, ability to travel up to 50%, US work authorization required.
2mo
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Technical Project Manager
Indianapolis, Indiana, United States
OnsiteFull Time
2+ YOEBachelor's in biomedical engineering or related, 2+ years in medical device or similarly regulated industry, knowledge of ISO 13485, design controls, change control, scheduling, regulatory documentation, and cross-functional project leadership.
ISO 13485, design controls, Change control system, CAPA, After-Action Review (AAR)
1mo
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Strategic Business Development Director
Indianapolis or Atlanta or Cincinnati or Louisville or Charlotte or Columbus or Nashville
FieldFull Time
10+ YOE10+ years business experience with 5+ years in business development/account management, knowledge of clinical engineering and medical device management, demonstrated ability to build pipeline and close large deals, strong presentation and communication skills.
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.
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