Senior NPI Engineer: Medical Device Process Innovator

EXALTA Group's; Mount Carmel Township (PA); On-site; USD 85,000 - 120,000; Full time

Job summary

Tyber Medical seeks a Manufacturing Engineer to develop, optimize, and document medical device manufacturing processes, collaborating with QA, Production, and Engineering to ensure product consistency and regulatory compliance. You will implement SWIs/SOPs, support training, and drive Kaizen and continuous improvements across sites.

The role requires expertise in Lean Six Sigma, SolidWorks, ERP, and CAPA investigations, with a focus on safety, quality, and efficiency in a fast-paced production

Qualifications

• Requires a Bachelor's degree in engineering and 5 years in medical device manufacturing.
• Strong knowledge of GMP, GDP, QMS and FDA/ISO standards.
• Proven Lean Six Sigma project experience.

Responsibilities

• Lead manufacturing optimization and efficiency projects with cross-functional teams.
• Conduct time studies, process flow analyses, and tool life studies.
• Apply Lean and Six Sigma to improve safety, quality, productivity, and cost.
• Design processes, fixtures, and tooling for manufacturing operations.
• Maintain and update SWIs, SOPs, BOOs, BOMs, CCs.
• Support training and on-floor operations; ensure compliance with cGMP and QMS.
• Investigate non-conformances and manage CAPA processes.
• Ensure adherence to Tyber Medical safety and OSHA requirements.

Skills

Manufacturing processes

Fixture design

Tooling development

SolidWorks

3D printing

Microsoft Office

Lean Six Sigma

Documentation (SWI/SOP)

CAPA investigations

Regulatory knowledge

ERP systems

Analytical skills

Cross-functional leadership

Independence under pressure

Communication

Physical stamina

Education

Bachelor's degree in Manufacturing Engineering, Industrial Engineering, Mechanical Engineering, or related field

High School Diploma, GED or equivalent

Job description

Tyber Medical seeks a Manufacturing Engineer to develop, optimize, and document medical device manufacturing processes, collaborating with QA, Production, and Engineering to ensure product consistency and regulatory compliance. You will implement SWIs/SOPs, support training, and drive Kaizen and continuous improvements across sites.

The role requires expertise in Lean Six Sigma, SolidWorks, ERP, and CAPA investigations, with a focus on safety, quality, and efficiency in a fast-paced production