AbbVieNYSE: ABBV: Develops and sells innovative pharmaceutical and biopharmaceutical medicines.
8+ YOE8+ years engineering design experience, 5+ years embedded Windows programming with C#/.NET, medical device/regulatory experience preferred, knowledge of IEC 62304, experience with RS232/SPI/USB and PID control, proficiency with Microsoft Word and Excel.
C#, .NET, .NET Framework, Windows, Windows Embedded, RS232, SPI, USB, IEC 62304, Microsoft Word, Microsoft Excel
III-V Device Design Engineer for Silicon Photonics Integration
Temecula, California, United States
OnsiteFull Time
Skorpios Technologies: Designs and manufactures silicon photonics for high-speed optical communications
10+ YOE10+ years' experience; MS or PhD in Physics, Electrical Engineering, or related field; deep understanding of lasers, MZM, photodiodes and EAM devices; extensive photonics device design and characterization experience.
ECI: Provides regulatory and engineering consulting for life sciences companies.
5+ YOEBachelor's in engineering or equivalent, 5+ years R&D medical device experience with electromechanical devices, knowledge of FDA quality systems and ISO standards, experience with SPC/DOE/ANOVA/FMEA/CAPA and validation (IQ/OQ/PQ).
SPC, DOE, ANOVA, GR&R, FMEA, CAPA, IQ, OQ/PQ, FDA 21CFR820, ISO 13485, ISO 14971, ISO 11607
Avante Health Solutions: Provider of medical equipment sales, service, and repair.
1+ YOE1-3 years in biomedical equipment repair; HS diploma; certification preferred; able to learn enterprise systems; trained to 21 CFR Part 820 and ISO 13485.
Microsoft Outlook, Microsoft Word, Microsoft Excel, Enterprise system, Documentation software
Product Development Electrical Engineer - Medical Device
Rancho Santa Margarita, California, United States
$72k-$90k/yrOnsiteFull Time
Applied Medical: Manufacturer of advanced medical devices and surgical products.
3+ YOEBachelor's in Electrical or Computer Engineering, 3+ years in electrical design/product development/R&D, hands-on PCB/Altium experience, analog/digital and high-speed signal design, lab troubleshooting, and ability to take designs from prototype to production.
BiVACOR: Developing an advanced total artificial heart for patients.
5+ YOEBS in engineering, 5+ years manufacturing engineering experience (medical device or regulated industry), expertise in process development, IQ/OQ/PQ, pFMEA, Lean/Six Sigma, and knowledge of FDA/ISO 13485 quality systems.
GlaukosNYSE: GKOS: Develops therapies and devices for treating chronic eye diseases.
2+ YOEBS Mechanical Engineering; 2+ years medical device/pharma experience; strong problem solving and communication skills; experience with GMP/ISO, process validation, and DOE.
SolidWorks, MS Project, MRP, DOE, FMEA, GMP, ISO 13485, Statistical Software, MS Word, Excel, Outlook, PowerPoint
StrykerNYSE: SYK: Manufactures medical devices and equipment for healthcare providers.
2+ YOEBachelor's in engineering, 2+ years relevant experience in medical device or regulated industry; experience with lean/continuous improvement and value stream mapping; strong problem solving and communication skills.
MicroVention: Manufacturer of neurovascular medical devices for stroke treatment.
4+ YOEBachelor's in engineering, 4+ years quality or manufacturing engineering in medical device/regulated manufacturing; experience with CAPA/NCR, validation, FMEA, IQ/OQ, audits, and statistical analysis; strong communication and MS Office/MiniTab skills.
Microsoft Word, Microsoft Excel, Microsoft Teams, Microsoft Outlook, MiniTab
Johnson & JohnsonNYSE: JNJ: Provides pharmaceutical products and medical technology healthcare solutions.
Seasoned mechanical engineer for medical device R&D with catheter experience, design controls and V&V knowledge, mechanical design and technical documentation skills, bachelor’s degree in mechanical engineering preferred, ability to mentor junior engineers.
BDNYSE: BDX: Manufactures medical devices, surgical instruments, and pharmacy automation systems.
3+ YOE3+ years engineering experience; experience with manufacturing/process validation, statistical techniques, supplier collaboration, documentation, and FDA medical device knowledge.
Beta BionicsNASDAQ: BBNX: Develops autonomous bionic pancreas systems for diabetes management.
7+ YOE7+ years in automation or manufacturing engineering in regulated medical device or similar; URS, validation, equipment ownership, debugging; SolidWorks; FDA/GMP knowledge.
Blue Bell or Somerset or Cary or Burlington or Houston or Leawood or Emeryville or Irvine or Germantown or Elkton or Cherry Hill or Lexington
$67k-$112k/yrFieldFull Time
IPS Integrated Project Services: Provides technical consulting, engineering, and construction for complex facilities.
2+ YOEBS in Engineering, 2+ years relevant experience in pharmaceutical/biotech/medical device CQV or QA, ability to write/execute C/Q/V protocols and perform field commissioning activities.
Freudenberg Group: Global manufacturer of specialized technical components and advanced materials
8+ YOE8+ years quality engineering in medical device manufacturing, bachelor in engineering/chemistry/biology, expertise with ISO 13485/ISO 14971/GMP, statistical methods (DOE, SPC), audits, CAPA, design control, and supplier quality.
Minitab, Six Sigma, SPC, DOE, FMEA, Control Plan, MSA, GD&T, IQ/OQ/PQ
Asahi InteccTokyo Stock Exchange: 7747: Manufactures and sells advanced medical devices for minimally invasive procedures.
2+ YOEBachelors in engineering, 2+ years in regulated medical device development or manufacturing, SolidWorks proficiency, familiarity with FDA/ISO/QSR preferred, ability to travel ~5%.
Fluxergy: Portable diagnostic platform for rapid point-of-care laboratory testing
5+ YOEB.S./M.S. in mechanical engineering or related; 5+ years developing electromechanical products (medical device or regulated industry preferred); SolidWorks, FEA, GD&T, injection molding, DFM/DFA, and regulatory familiarity (ISO 13485, FDA QSR).
AlconNYSE: ALC: Manufactures ophthalmic surgical equipment and vision care products.
5+ YOE5+ years opto-mechanical engineering experience in medical devices, CAD and PLM proficiency, optical/optomechanical design and metrology, design control and risk management knowledge.
Edwards LifesciencesNYSE: EW: Designs and manufactures medical devices for structural heart disease.
Bachelor's in related field and experience in quality engineering/management in medical device industry; leadership, project management, validation, and regulatory compliance experience required.
Lean, 6-sigma, Design of Experiments, Statistical Process Control, FMEA, IQ/OQ/PQ
Microchip TechnologyNasdaq: MCHP: Manufacturer of microcontrollers, analog, and mixed-signal integrated circuits.
0+ YOEBachelor's in electrical, mechanical, or materials engineering required; 0–3 years experience preferred. Must have Excel skills; AutoCAD, ProE/SolidWorks or ANSYS experience a plus. Experience with electro-mechanical devices, root cause analysis, testing, and familiarity with metal alloys.