Validation Engineer Manufacturing Operations

North Haven, CT - USA

Monthly Salary: Not Disclosed

Posted on: 5 hours ago

Vacancies: 1 Vacancy

Job Summary

Role: Validation Engineer - Manufacturing Operations
Location: North Haven CT (Onsite)
Duration: Direct Hire Full time

Job Description

NEED SOMEONE WITH PRIOR MEDTRONIC EXPERIENCE

Soft Skills

Strong ownership mindset with the ability to lead cross-functional teams under regulated constraints.
Effective communicator with experience presenting technical content to leadership quality and regulatory teams.
Ability to manage multiple priorities drive structured problem-solving and implement scalable engineering solutions.

Key Responsibilities

Oversee and optimize complex production processes for surgical devices ensuring alignment with efficiency and quality standards.
Act as the primary technical expert for electro-mechanical equipment issues identifying root causes and implementing sustainable corrective actions to minimize downtime.
Lead the development and execution of validation strategies including Installation Operational and Performance Qualifications (IQ/OQ/PQ) for new and existing equipment.
Apply Lean principles to identify opportunities for waste reduction and process stability.
Lead non-conformance (NCMR) and Corrective and Preventive Action (CAPA) investigations to uphold strict quality system requirements.
Support the adaptation of machine or equipment design to factory and production conditions

Required Qualifications

Bachelors degree in Electrical Engineering Controls Automation Mechatronics or related field.
10 years of relevant manufacturing engineering experience (or 8 years with a Masters degree).
Mastery of medical device process validation (IQ/OQ/PQ) statistical analysis (Minitab) and high-volume manufacturing assembly.
Proven ability to troubleshoot complex automated systems including robotics motion control and machine vision.
Strong background in statistical analysis including process capability process control DOE and inspection design In-depth understanding of Production Part Approval Process (PPAP) for component qualification

Qualification:

Bachelors degree in Electrical Engineering Controls Automation Mechatronics or related field.

Regards

Jitendra Kumar Shakya

Senior Talent Acquisition Specialist

Wise Equation Solutions Inc.

(Service-Disabled Veteran-Owned Company)

Office : Ext: 124

Email:

Role: Validation Engineer - Manufacturing Operations Location: North Haven CT (Onsite) Duration: Direct Hire Full time Job Description NEED SOMEONE WITH PRIOR MEDTRONIC EXPERIENCE Soft Skills Strong ownership mindset with the ability to lead cross-functional teams under regulated constrai...