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23 iso 13485 jobs at 13 companies in Boulder, CO

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Quality Assurance Manager
Louisville or Pennsylvania
$120k-$140k/yr OnsiteFull Time
Filtration Group
Filtration Group: Manufactures high-performance air and liquid filtration systems.
5+ YOE5+ years QMS management with ISO 9001/ISO 13485/MDSAP experience, audit experience, ITAR knowledge, intermediate-to-expert Microsoft Office skills, bachelor’s degree preferred (engineering).
Microsoft Office
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Prin Quality Engineer
Lafayette or North Haven or Boston or Minneapolis or Los Angeles County
$121k-$181k/yr OnsiteFull Time
Medtronic
MedtronicNYSE: MDT: Developing and manufacturing medical technologies and therapies globally.
Bachelor's degree in engineering or related technical field; in-depth FDA, ISO 13485, and ISO 14971 knowledge; quality, risk management, regulatory, statistics, root-cause analysis, leadership, and project management expertise.
FDA, ISO 13485, ISO 14971, ISO 62304, FDA Part 820, Design Failure Modes and Effects Analyses (DFMEAs), Process FMEA, User FMEA
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Director of Operations
Golden, Colorado, United States
$100k-$145k/yr OnsiteFull Time
BioIntelliSense
BioIntelliSense: Provides medical-grade wearable devices for continuous remote patient monitoring.
6+ YOEProgram and operations leadership in medical device manufacturing, 6+ years program/project experience, bachelor\u0002s in engineering or related, knowledge of FDA 21 CFR Part 820/ISO 13485/ISO 14971, experience with ERP/PLM and program tools.
Greenlight Guru, Arena, Agile, MasterControl, NetSuite, SAP, Oracle, MS Project, SmartSheet, Jira, Asana, Microsoft Excel, Microsoft PowerPoint, Microsoft Word, Microsoft Outlook, Power BI, Tableau
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Plant Manager
Denver or Clinton Township
OnsiteFull Time
TriMas
TriMasNASDAQ: TRS: Manufactures engineered products for packaging, aerospace, and industrial markets.
10+ YOE10+ years leadership in injection molding or advanced manufacturing, expertise in scientific molding, Lean/Six Sigma, regulated environments (ISO 13485/FDA/ITAR), automation and financial management.
RJG, Lean Manufacturing, Six Sigma
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Sr Design Quality Engineer
Lafayette, Colorado, United States
$98k-$148k/yr OnsiteFull Time
Medtronic
MedtronicNew York Stock Exchange: MDT: Develops and manufactures medical devices and digital health solutions.
4+ YOEBachelor's degree plus 4+ years quality experience (2+ with MS). Experience in medical device/regulated environments, ISO 13485/FDA QSR/EU MDR, ISO 14971 risk management, design controls, V&V, CAPA, and electronic hardware experience.
Minitab
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2w
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Sr Manager, Regulatory Affairs (11624)
Englewood, Colorado, United States
$120k-$150k/yr HybridFull Time
Zimmer Biomet
Zimmer BiometNYSE: ZBH: Manufactures orthopedic implants and robotic surgical systems.
7+ YOEBachelor's degree and 7+ years of relevant experience required. Requires US FDA regulatory expertise, ISO 13485:2016 and 21 CFR knowledge, leadership ability, and proficiency with Microsoft Office tools.
US FDA Premarket Approval, US FDA HUD/HDE, US FDA Section 520(b) Custom Device Exemption, US FDA Compassionate Use, US FDA Investigational Device Exemption, US Premarket Notification (510(k)), Human Cell and Tissue Products (HCT/P), RIMS, GUDID, Microsoft Word, Microsoft Excel, Microsoft PowerPoint, Microsoft Outlook, ISO 13485:2016, US 21 CFR
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Mechanical Engineer III - Advanced Surgical
Denver, Colorado, United States
$82k-$125k/yr OnsiteFull Time
CONMED
CONMEDNYSE: CNMD: Manufacturer of surgical instruments and patient monitoring medical devices.
5+ YOEBS in Mechanical/Biomedical Engineering, 5+ years product development experience, SolidWorks CAD proficiency, regulated environment experience (21 CFR 820/ISO 13485), design control and risk management knowledge.
SolidWorks
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Director of Quality Engineering
Centennial, Colorado, United States
$140k-$170k/yr HybridFull Time
ProEdge Dental Water Labs
ProEdge Dental Water Labs: Provides dental waterline testing and water treatment products.
Leadership in quality engineering for medical device/Class I products; QMS ownership; FDA and ISO 13485 regulatory oversight; process improvement (Lean/Six Sigma); drive defect prevention and audit readiness.
Lean/Six Sigma, Quality Management System (QMS), ISO 13485, FDA
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Territory Sales Manager, SLC, Utah/Denver, Colorado
United States or Denver
FieldFull Time
Q'Apel Medical
Q'Apel Medical: Developing novel access device technology for vascular interventions.
5+ YOE5+ years medical device sales experience in neurovascular or related sectors, bachelor’s degree, familiarity with FDA QSR and ISO 13485, proven sales track record, strong communication and presentation skills, willingness to travel extensively.
Microsoft PowerPoint, Microsoft Word, Microsoft Excel
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Vice President, MedTech
Littleton, Colorado, United States
$225k-$275k/yr OnsiteFull Time
3D Systems
3D SystemsNYSE: DDD: Provides 3D printing hardware, materials, and digital manufacturing services.
15+ YOE15+ Mgmt15+ years MedTech/regulatory leadership with P&L and cross-functional responsibility; Bachelor's in Engineering/Business/Life Sciences required; strong FDA/EU MDR and ISO 13485 knowledge; proven commercial and operational track record.
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Quality Engineer
Arvada, Colorado, United States
$85k-$95k/yr OnsiteFull Time
LivaNova
LivaNovaNASDAQ: LIVN: Manufactures medical devices for cardiac and neurological therapies.
1+ YOE1-3 years in Class II/III medical device or regulatory industry; knowledge of FDA and ISO 13485; CAPA and complaint investigation experience; risk management and data analysis skills; Bachelor's in technical/scientific discipline required.
ISO 13485, MDSAP, CAPA
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Sr. Manufacturing/Process Engineer
Westminster, Colorado, United States
$115k-$125k/yr OnsiteFull Time
TriSalus Life Sciences
TriSalus Life SciencesNASDAQ: TLSI: Develops drug delivery systems and immunotherapies for cancer treatment.
10+ YOEBS in engineering required; 10+ years medical device manufacturing experience in FDA-regulated environment; expertise in process validation (IQ/OQ/PQ), DOE/SPC/MSA, PFMEA, CAPA, ISO 13485 and 21 CFR Part 820; cleanroom experience.
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Principal, RA Specialist
Boulder or Remote
$110k-$135k/yr RemoteFull Time
Danaher
DanaherNYSE: DHR: Develops scientific instruments and diagnostic tools for healthcare markets.
7+ YOEBachelor’s degree in a technical field; 7+ years in regulated environment; 4+ years global regulatory experience (IVD); US FDA/EU IVDR/510(k) knowledge; Design Control and Risk Management experience; ISO 13485 experience; strong collaboration and leadership.
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3mo
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Senior Software Engineer (Loveland, CO)
Loveland, Colorado, United States
$107k-$134k/yr OnsiteFull Time
Antech
Antech: Provides veterinary diagnostic services and technology for animal health.
5+ YOEFive or more years in professional software development; strong C++ and embedded Linux experience; DevOps (Docker, GitLab CI); cloud infrastructure (AWS/Azure); GUI with Qt; Yocto; LIMS/EHR connectivity; regulated software (IEC 62304 FDA QSR ISO 13485).
C++, Embedded Linux, Docker, GitLab CI, AWS, Azure, Qt, Yocto
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