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).