The Engineering Manager leads manufacturing engineering functions to support the development, validation, implementation, and continuous improvement of production processes for medical device products and software systems. This role is responsible for ensuring process robustness, equipment performance, automation projects, product transfers, and compliance with FDA, GMP, and ISO 13485 requirements. The manager drives Lean Manufacturing and Six Sigma initiatives while overseeing CAPA investigations and nonconformance reports to optimize quality, productivity, and cost. Key responsibilities include managing engineering teams, conducting feasibility studies, and coordinating with outside suppliers. The role requires expertise in process validations (IQ/OQ/PQ), equipment qualification, root cause analysis, SPC, FMEA, DOE, and project management. This position solves critical manufacturing challenges within a regulated environment by ensuring that complex medical technologies are produced reliably while maintaining strict adherence to international quality standards and regulatory requirements.
What does a Engineering Manager earn in Remote?
Median $235250 from 43 postings across 20 companies.
Process Development
IQ/OQ/PQ
Design of Experiments (DOE)
Statistical Process Control (SPC)
FMEA
Automation
Robotics
Injection Molding
Extrusion
CAPA
Digital Manufacturing
Injection Molding
Six Sigma
Lean Manufacturing
Vision Systems
Process Validation
GMP
ISO 13485
Root Cause Analysis
Capital Projects
Manufacturing Engineering
QMS
CAPA
ISO 13485
FDA QSR
Six Sigma
Lean
DMAIC
Minitab
Python
VBA
Root Cause Analysis
FMEA
MES
Data Analytics
Statistical Analysis
Validation
Risk Management
ISO 13485
FDA Quality System
CAPA
Root Cause Analysis
Risk Management
Process Validation
Six Sigma
Change Control
Nonconforming Product Control
Quality Engineering
Product Reliability
Continuous Improvement