1740 Software Engineer jobs in Livingston,NJ

Bachelor's degree in Regulatory Affairs, Engineering, Life Sciences, Quality, or a related technical field required
Advanced degree preferred
6-10+ years of progressive medical device regulatory affairs experience preferred
RAC certification, ISO 13485 lead auditor training, MDR/MDSAP training, or comparable regulatory credential strongly preferred
Demonstrated hands-on experience with FDA requirements, 21 CFR Part 820/QMSR transition awareness, ISO 13485:2016, EU MDR 2017/745, UK MDR/UKCA, MDSAP jurisdictions, Health Canada, and TGA expectations
Experience with Class I and Class II medical devices
Experience with software, SaMD, connected devices, or prescription/OTC device labeling is a plus
Proven ability to support or lead regulatory submissions, Technical Documentation maintenance, regulatory change assessments, labeling reviews, PMS/vigilance inputs, and audit support
Experience working in an eQMS/document management system and in cross-functional product development or change control environments
Travel of approximately 20%, including potential support of audits, inspections, supplier visits, regulatory meetings, or trade/business activities

SmartExplore AI is experimental.

Recommended

Apply Directly

Staff Mechanical Design Engineer, EPC (35159)

STSI (Staffing Technical Services Inc.)

Brooklyn, NY 11217

~ 48 min OnsiteHealth InsuranceRetirement Benefit

Licensed Professional Engineer with NCEES record with ability to apply for NV and SC
Bachelor's Degree in Mechanical Engineering or similar discipline
8+ years of work experience in HVAC and Plumbing/FP design
Proficient in the use of AutoCAD
Strong experience with engineering software packages: Pipe-Flo, AFT Arrow or other hydraulic modeling application, Caesar II, AspenTech applications and/or Applied Flow Technology applications, Carrier HAP, Trane Trace, Navisworks, Bluebeam
Review conceptual designs from developing Engineers and identify technical and financial risks
Expert familiarity with ICC including International Energy Conservation, Mechanical, Plumbing and Fire Protection Codes, NFPA standards, SMACNA duct construction standards, ACGIH Ventilation Practices and ASHRAE
Design ownership for a wide range of mechanical and plumbing systems including: industrial/non-potable water, HVAC systems (labs, offices, industrial plants), process heating / cooling systems, humidifiers, dehumidifiers, abatement systems (dust collectors, scrubbers), cooling towers, fans/pumps, plumbing, etc.
Experience with reviewing mechanical engineering deliverables with respect to code compliance and ensuring design maintains quality
Experience developing and improving project workflows and standards
Experience participating in on-field construction and commissioning activities as point of contact for technical questions and real-time issue resolution
Multi-discipline collaboration on equipment general arrangements, P&IDs, isometrics, tie-in lists and material takeoffs
Travel to project site and meetings as needed

SmartExplore AI is experimental.

New, Posted just now

Recommended