Develop and implement NPI processes for new product introduction.
Create and maintain production documentation: work instructions, flow charts, procedures, routings, and labels.
Update drawings and 3D models with R D to meet production needs.
Lead and track engineering projects using tools like Gantt charts, with a focus on defined KPIs.
Collaborate across departments to ensure product design meets safety, testability, manufacturability, cost, and DFX requirements.
Train and support production teams during new product launches.
Plan and drive validation testing to minimize process and design variability.
Develop and integrate electronic/mechanical prototypes and TEST equipment for new products.
Ensure robust risk mitigation (FMEA) with cross-functional teams.
Actively participate in design reviews and product redesigns.
Source alternative materials in line with existing BOMs.
Create and maintain production documentation: work instructions, flow charts, procedures, routings, and labels.
Update drawings and 3D models with R D to meet production needs.
Lead and track engineering projects using tools like Gantt charts, with a focus on defined KPIs.
Collaborate across departments to ensure product design meets safety, testability, manufacturability, cost, and DFX requirements.
Train and support production teams during new product launches.
Plan and drive validation testing to minimize process and design variability.
Develop and integrate electronic/mechanical prototypes and TEST equipment for new products.
Ensure robust risk mitigation (FMEA) with cross-functional teams.
Actively participate in design reviews and product redesigns.
Source alternative materials in line with existing BOMs.
Requirements:
Bachelors degree or better in an engineering discipline required, mechanical preferred.
5+ years experience in an engineering or manufacturing role in a medical device and multidisciplinary.
Experience with ECO process and implantation at contract manufacturer site.
Experience in production planning, scheduling, or related manufacturing process control.
Experience in a manufacturing environment – Essential.
Experience with Priority – Preferred.
Experience with Solidwork PDM.
Understanding of FDA, ISO, and IEC 60601 standards and regulations.
Experience of Delivering Results Problem Solving.
Bachelors degree or better in an engineering discipline required, mechanical preferred.
5+ years experience in an engineering or manufacturing role in a medical device and multidisciplinary.
Experience with ECO process and implantation at contract manufacturer site.
Experience in production planning, scheduling, or related manufacturing process control.
Experience in a manufacturing environment – Essential.
Experience with Priority – Preferred.
Experience with Solidwork PDM.
Understanding of FDA, ISO, and IEC 60601 standards and regulations.
Experience of Delivering Results Problem Solving.
This position is open to all candidates.
