What are the responsibilities and job description for the Sr. Manufacturing Engineer with CAPA position at Zapnix LLC?
Job Title: Sr. Manufacturing Engineer with CAPA
Location: North Haven, CT (Onsite)
Job Description & Skill Requirement:
- Provide technical leadership and daily manufacturing support for multiple product families within Medtronic's North Haven manufacturing operations.
- Responsible for maintaining and improving product quality, reducing manufacturing costs, optimizing manufacturing processes, and ensuring compliance with safety and regulatory requirements. Partner with Production, Quality, Operations,
- Supplier Quality, and Engineering teams to investigate manufacturing issues, perform root cause analysis, qualify components, implement corrective actions, and drive continuous improvement initiatives.
- Support process validation activities, manufacturing process development, equipment improvements, and operational excellence projects. Strong problem-solving, manufacturing process knowledge, project management, technical communication, and leadership skills are required. Experience with Lean Manufacturing, Six Sigma, CAPA, PFMEA, and medical device quality systems is highly desirable.
Qualification:
- Bachelor's Degree in Mechanical Engineering, Manufacturing Engineering, Industrial Engineering, or related Engineering discipline.
- 7 years of Experience in manufacturing engineering within medical devices or other regulated industries.
- Strong knowledge of manufacturing processes, process validation, quality systems, and regulatory requirements.
- Experience with root cause investigations, process improvements, and cross-functional project execution.
- Lean Manufacturing and Six Sigma experience preferred.