Development Engineer
Job Description:
Medical Devices | Component Development | Project Management
Join a highly specialized team working on cutting-edge medical device development and manufacturing excellence. We're looking for a skilled Development Engineer with deep expertise in component qualification, cost reduction strategies, and plant transfer processes.
Responsibilities:
Drive design, development, and qualification of metallic and plastic medical device components.
Lead project management and cross-functional coordination for development & commissioning effort.
Perform statistical analysis, MSA, DOE, and implement PPAP-based component qualification.
Execute risk management including FMEA, process validation, and GMP compliance
Manage plant transfer and cost optimization through process innovation (not just supplier shifts).
Collaborate on product design with DFMA principles to reduce complexity and improve manufacturability.
Conduct change management activities for multiple projects in parallel.
Interface with engineering, manufacturing, and supply chain to ensure seamless execution.
Requirements:
6-8 years in medical device or related regulated industry.
Hands-on experience with.
Component manufacturing technologies - CNC, MIM, fine blanking, welding, 3D printing, plastic injection melding.
Process Validation, GMP compliance, and Design of Experiments (DOE)
GD&T, DFMA, SPC, MSA, Gage R&R.
Strong experience in Project Management, commissioning, and documentation.
Excellent communication, cross-functional leadership, and stakeholder alignment.
Experience with cost-reduction programs through engineering/process improvements.
Prior involvement in plant transfer activities or new line commissioning.
Knowledge of regulatory requirements in the medical device industry (FDA, ISO).
Employers have access to artificial intelligence language tools (AI) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.
Report this job
Dice Id:
91116760
Position Id:
2a15b40d3d4ba015748664fac63c15a0
Job Description:
Medical Devices | Component Development | Project Management
Join a highly specialized team working on cutting-edge medical device development and manufacturing excellence. We're looking for a skilled Development Engineer with deep expertise in component qualification, cost reduction strategies, and plant transfer processes.
Responsibilities:
Drive design, development, and qualification of metallic and plastic medical device components.
Lead project management and cross-functional coordination for development & commissioning effort.
Perform statistical analysis, MSA, DOE, and implement PPAP-based component qualification.
Execute risk management including FMEA, process validation, and GMP compliance
Manage plant transfer and cost optimization through process innovation (not just supplier shifts).
Collaborate on product design with DFMA principles to reduce complexity and improve manufacturability.
Conduct change management activities for multiple projects in parallel.
Interface with engineering, manufacturing, and supply chain to ensure seamless execution.
Requirements:
6-8 years in medical device or related regulated industry.
Hands-on experience with.
Component manufacturing technologies - CNC, MIM, fine blanking, welding, 3D printing, plastic injection melding.
Process Validation, GMP compliance, and Design of Experiments (DOE)
GD&T, DFMA, SPC, MSA, Gage R&R.
Strong experience in Project Management, commissioning, and documentation.
Excellent communication, cross-functional leadership, and stakeholder alignment.
Experience with cost-reduction programs through engineering/process improvements.
Prior involvement in plant transfer activities or new line commissioning.
Knowledge of regulatory requirements in the medical device industry (FDA, ISO).
Employers have access to artificial intelligence language tools (AI) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.
Report this job
Dice Id:
91116760
Position Id:
2a15b40d3d4ba015748664fac63c15a0
Job ID: 482396833
Originally Posted on: 6/23/2025
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