146 medical device manager engineering jobs at 61 companies in Boston, MA
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Associate Director, Device Engineering
Waltham, Massachusetts, United States
$159k-$195k/yr HybridFull Time
10+ YOE3+ Mgmt10+ years in medical device or combination product development, including 3+ years leading teams; autoinjector, syringe, or multidose pen launch experience; bachelor's degree in engineering required.
FDA, ISO 13485, ISO 14971, FMEA, IEC 62366, ISO 11608-1, ISO 11040, ASTM D4169, 21 CFR Part 4, IND, IMPD, NDA, BLA
2mo
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Senior Device Quality Engineering Lead
Cambridge or Research Triangle Park
$138k-$185k/yr HybridFull Time
7+ YOEBS in engineering or related discipline, 7+ years in medical device/combination product quality with design control and risk management expertise, regulatory knowledge, and cross-functional leadership experience.
3d
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Associate Director, Device Lead
Waltham or Zebulon or Marietta or Ware or Upper Providence or Barnard Castle or Cambridge or Rockville or San Francisco
$143k-$238k/yr HybridFull Time
10+ YOEBachelor's in engineering or science with 10+ years in medical device manufacturing, or master's with 5+ years; requires GMP, regulatory, ISO, device lifecycle, risk management, and technology transfer expertise.
FDA 21 CFR 820, EU MDR, ISO 13485, ISO 14971, ISO 10993, GMP, ICH Guidelines, FDA QSR, DHF, Technical File, Microsoft Excel
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Senior Medical Device Compliance Engineer
Needham, Massachusetts, United States
$88k-$150k/yr OnsiteFull Time
5+ YOEBachelor’s degree required and 5+ years in medical device design controls and post-market sustaining; expertise in ISO 14971, risk management, DFMEA, requirements, V&V, ECNs, and audits.
ISO 14971, DFMEA, Electronic Change Notice (ECN)
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Program Manager - Medical Device
Beverly or Baldwin Park
$120k-$140k/yr OnsiteFull Time
8+ YOEBachelor's in engineering/chemistry/biology, 8+ years in medical device, 6+ years program/project management in manufacturing, knowledge of ISO/GMP/regulatory (FDA/MDR/Health Canada/PMDA), DOE/Lean/Six Sigma experience.
2mo
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Senior Manager, Software Device Quality
Lexington, Massachusetts, United States
$137k-$215k/yr OnsiteFull Time
7+ YOEBachelor's in engineering or related field,7+ years QA/engineering experience in medical devices/combination products,knowledge of ISO 13485,ISO 14971,MDR,MDSAP,21 CFR Part 820,experience with regulatory submissions and risk management.
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Manager, Quality Engineering
Salem, New Hampshire, United States
FieldFull Time
10+ YOEBachelor's in engineering,10+ years quality management experience in medical device manufacturing, expertise in quality engineering, risk management, SPC, root cause analysis, and leading multi-site teams.
Minitab, ERP systems, electronic quality systems
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Manager, Manufacturing Engineering
Acton, Massachusetts, United States
$123k-$184k/yr OnsiteFull Time
10+ YOE1+ MgmtB.S. in Mechanical Engineering with 10+ years medical device/manufacturing experience; 1+ year managing employees; strong mechanical troubleshooting, project management, validation, and structured problem solving skills.
Microsoft Office, Microsoft Excel, Minitab, JMP, Solidworks
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Senior Software Project Manager - Medical Device #3065
Marlborough, Massachusetts, United States
HybridContract, Full Time
5+ YOEBachelor's in engineering or related,5+ years project/program management in regulated medical device software,proficiency with Jira/Confluence,Agile/Scrum,CSM preferred,strong stakeholder and risk management.
Jira, Confluence, Jira Advanced Roadmaps
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Technical Fellow, Systems & Device Engineering
Newton, Massachusetts, United States
OnsiteFull Time
8+ YOE8+ years experience in medical device and robotics engineering with systems-level hardware architecture, guidewire/device design, usability engineering, and regulatory design controls.
2w
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Engineering Project Manager
Manchester, New Hampshire, United States
OnsiteFull Time
5+ YOE5+ MgmtBachelor's in engineering, 5+ years leading medical device product development teams, experience with electromechanical products and embedded software, strong project management, schedule/budget/resource management, and communication skills.
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Device Quality Engineer - Device Risk Management and Surveillance Excellence
Cambridge, Massachusetts, United States
$90k-$130k/yr OnsiteFull Time
5+ YOEBS in Engineering or related science; MS desired; 5+ years medical device experience; 3+ years risk management and post-market surveillance; ISO 14971, MDR, and 21 CFR 820 knowledge; English required; French or German a plus.
ISO 14971, Post-Market Surveillance, FMEA, Regulatory Compliance (MDR / 21 CFR 820), Design Controls, DHF Management
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Sr Robotics Systems Engineering Manager
Boston or Raynham
$137k-$236k/yr HybridFull Time
7+ YOEBachelor’s or master’s degree in systems engineering, mechatronics, electrical engineering, or related field; 7+ years multidisciplinary systems engineering and 5+ years surgical robotics or complex medical device experience.
DOORS, Jama, Polarion, Python, LabVIEW, MATLAB, SAP Product Lifecycle Management, Model-Based Systems Engineering (MBSE), UML
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Sr Robotics Systems Engineering Manager
Boston or Raynham
$137k-$236k/yr HybridFull Time
7+ YOEBachelor’s or master’s degree in systems, mechatronics, electrical engineering, or related field; 7+ years multidisciplinary systems engineering and 5+ years surgical robotics or complex medical devices experience.
DOORS, Jama, Polarion, Python, LabVIEW, MATLAB, Model-Based Systems Engineering (MBSE), UML, SAP Product Lifecycle Management
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Sr Manager, R&D Sustaining Engineering
Marlborough, Massachusetts, United States
$146k-$244k/yr OnsiteFull Time
8+ YOE5+ MgmtBachelor's degree in engineering or related field, 8+ years sustaining engineering experience, and 5+ years people management. Requires medical device regulatory, quality systems, project management, and leadership expertise.
FDA Quality Systems Regulation, ISO 13485, ISO 14971
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Assistant Project Manager - Medical
Marlborough, Massachusetts, United States
OnsiteFull Time
3+ YOEBachelor’s in engineering required; 3+ years project management experience in medical device industry; knowledge of design controls, risk management, manufacturing transfer, and Microsoft Project.
Microsoft Project
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Senior Group Leader - Systems Engineering
Bedford, Massachusetts, United States
$160k-$190k/yr OnsiteFull Time
15+ YOEBachelor's degree in engineering or related discipline, plus 15 years of relevant engineering experience or 10 years with an advanced degree. Requires medical device design controls and systems engineering expertise.
JAMA, DOORS, Waterfall, Agile, ISO 13485, ISO 14971, IEC 60601
3d
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Quality Assurance Specialist II, Device Engineering
Woburn, Massachusetts, United States
$85k-$105k/yr OnsiteFull Time
4+ YOERequires 4–5 years of quality experience in a cGMP-regulated medical device, pharmaceutical, biologics, or combination product environment, plus ISO 13485, FDA QSR, design controls, risk management, validation, and GMP documentation experience.
Microsoft Word, Microsoft Excel, Microsoft PowerPoint, Quality Management System (QMS), Design History File (DHF), Design Verification and Validation (DVV), Failure Mode and Effects Analysis (FMEA), Test Method Validation (TMV), Process Validation (PV), Corrective and Preventive Action (CAPA)
3w
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Production Eng Manager, 5.5 Value Stream
Danvers, Massachusetts, United States
$102k-$177k/yr OnsiteFull Time
6+ YOEBachelor's in engineering,6+ years manufacturing experience (medical device/cleanroom preferred),leadership experience,knowledge of FDA QSR/ISO/GMP,Lean Six Sigma expertise,project management,SAP and Microsoft Office proficiency.
Microsoft Office, SAP
2mo
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Customer Success Manager - Medical Devices
San Francisco or Boston or Cambridge
$140k-$160k/yr OnsiteFull Time
10+ YOEEngineering BS or equivalent, 10+ years experience (consulting/program management or medical device product development), knowledge of medical device processes and regulations (ISO 13485, 21 CFR Part 11), strong communication and executive presentation skills.
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