40 medical device engineer jobs at 17 companies in Sycamore, IL
2mo
Save
Mark Applied
Hide
2mo
Contract Medical Device Lead Auditor
Schaumburg, Illinois, United States
FieldPart Time, Contract
DQS: Private global certification body providing audits, certifications, and management-system assessments for organizations.
4+ YOEBachelor's in science/engineering required; 4+ years quality systems and medical device experience; ISO 9001/13485 and GMP auditing experience; ability to pass a 40-hour lead auditor course; knowledge of ISO 14971 and device regulatory requirements.
North Chicago or South San Francisco or Irvine or Germany
$97k-$184k/yrOnsiteFull Time
AbbVieNYSE: ABBV: Global biopharmaceutical discovering and delivering innovative medicines.
8+ YOEBS, MS, or PhD in engineering; 12 years with BS or 8 years with MS/MBA; medical device and drug delivery experience; design control and combination product development knowledge; strong analytical and communication skills.
FlexNASDAQ: FLEX: Global manufacturing partner providing design, engineering, and supply chain solutions.
10+ YOEBachelor's in Engineering/Business, 10+ years progressive program management experience in medical device/regulated manufacturing, strong leadership, stakeholder and financial management, negotiation skills, and experience with Smartsheet and Microsoft Project.
Ingersoll RandNYSE: IR: Provider of mission-critical flow creation and industrial solutions.
5+ YOEBachelor’s degree and 5+ years of medical device account management plus 5+ years of mechanical, biomedical, or related engineering experience. Requires strategic sales, negotiation, and cross-functional leadership skills.
MedlineNasdaq: MDLN: Manufacturer and distributor of medical supplies and clinical solutions.
4+ YOEBachelor’s degree in a related engineering, human factors, usability, psychology, or biomedical field and at least 4 years of human factors engineering experience; medical device experience preferred.
FDA, AAMI HE 75, ISO 62366, IEC 60601-1-6, ISO 11607-1, 21 CFR 820.30, ISO 14971
StrykerNYSE: SYK: Global leader in medical technologies for orthopaedics, medical, surgical, and neurotechnology.
2+ YOEBachelor's degree in biomedical, mechanical, electrical, or related engineering and 2+ years of experience. Test automation and medical device experience preferred.
Baxter InternationalNYSE: BAX: Global medical products and healthcare technology.
5+ YOEBachelor's in engineering, 5+ years medical device risk management/product development experience, working knowledge of ISO 14971, experience with FMEA/FTA/ hazard analysis and DOORS, strong analytical and communication skills.
Medical Murray: Privately owned medical-device CDMO designing and manufacturing catheters and implants for device companies.
2+ YOEBachelor's or master’s in biomedical/mechanical or related engineering; 2–5 years medical device experience; SolidWorks proficiency; experience with design controls, verification/validation, FMEA; project leadership and Microsoft Office skills.
Avalign Technologies: Medical-device manufacturer supplying surgical implants, instruments, cutting tools, and delivery systems to OEMs and hospitals.
5+ YOEBachelor's in engineering or science (or equivalent), 5+ years quality/engineering experience, 2+ years medical device/design-control experience, knowledge of ISO 13485/14971/21 CFR 820/MDR, and ability to travel up to 25%.
Hollister Incorporated: Independent, employee-owned healthcare manufacturer serving patients and professionals with ostomy, continence, and critical care products.
5+ YOEBachelor’s degree in engineering, science, or related technical discipline and 5–8 years of related experience; medical device, design control, quality systems, testing, and regulatory experience preferred.
Del Medical: Privately held U.S. medical imaging manufacturer and distributor serving hospitals, imaging centers, clinics, and authorized dealers.
10+ YOE10+ years in mechanical design for medical devices; SolidWorks and AutoCAD; stress analysis/FEA; FDA/ISO 13485 knowledge; design for manufacturability.
MedTorque: Private U.S. contract manufacturer producing precision-machined components, medical devices, implants, instruments, and industrial cutting tools for OEMs.
5+ YOEEnsure regulatory and quality system compliance for medical devices, lead audits, manage validations, perform risk assessments, and support CAPA/MRB processes.
3+ YOEBachelor's degree in relevant engineering,3+ years embedded firmware development experience,proficiency in Embedded C/C++,microcontroller firmware,hardware/software integration,RTOS and communication protocols.
Nemera: Private global drug delivery device manufacturer serving pharmaceutical, biotechnology, and generic companies.
3+ YOEBachelor's degree in engineering, science, or related field; 3+ years of quality experience; medical device and ISO 13485 experience preferred; statistical, validation, technical writing, and communication skills required.
Microsoft Office, SAP, CAPA, FMEA, Design of Experiments, Cause and Effect, Flow Charts, SPC, Six Sigma, ISO 13485, FDA QSR, IQ/OQ/PQ, GR&R
AbbottNYSE: ABT: Global healthcare technology focused on life-changing medical innovations.
4+ YOEBachelor's degree in computer science, software engineering, or related field; 4+ years in quality or related work; knowledge of FDA QSR, ISO guidelines, Medical Device Directive, and 21 CFR Part 11.
GE HealthCareNasdaq: GEHC: Global medical technology and digital solutions innovator.
2+ YOEPerform preventative maintenance, equipment installation and basic troubleshooting on medical devices; valid driver's license and ability to lift 35 lbs; legal U.S. work authorization required.
Advocate Health Care: Nonprofit integrated health system serving patients across six states.
Associate degree in electronics, computer, or biomedical equipment technology plus 5 years equivalent healthcare experience, or 7 years comparable hospital experience. Requires Illinois driver's license and advanced medical-device maintenance expertise.
Microsoft products, web, electronic test equipment, phantoms, hand tools
PCI Pharma Services: Global contract development and manufacturing organization for biopharma.
5+ YOECollege/trade degree in engineering/science, 5+ years in FDA-regulated industry (medical device/combination products preferred), proficiency with Microsoft Office, ERP/eQMS, strong RCA and analytical skills.
Microsoft Office, ERP, eQMS, Measurement System Analysis (MSA), GR&R, ISO 14971, ISO 13485, FDA 21 CFR 820
SterigenicsNASDAQ: SHC: Private Sotera Health business providing contract sterilization and irradiation services to medical-device, pharmaceutical, food-safety, and advanced-application customers.
2+ YOEBachelors in life sciences/engineering, 2 years regulatory affairs experience in medical device/pharma/tissue/food, working knowledge of FDA and ISO 13485, familiarity with FDA listing systems, attention to detail; PCQI/FDQI preferred.