CSV Analyst - Sans Juan, PR (Onsite)

[Sid K]

Hi Folks,

My client is looking for CSV Analyst for 10 Month Contract role based in Sans Juan, PR  (Onsite)

Position: CSV Analyst

Location:  Sans Juan, PR (Onsite)

Duration: 10 Month Contract 

 

Key Responsibilities

Process Optimization & Technical Leadership

• Develop, implement, and optimize manufacturing processes including molding, laser welding, and bonding to improve efficiency, yield, and cost performance.

• Apply Lean Six Sigma methodologies and Design of Experiments (DOE) to drive continuous improvement.

• Create, update, and maintain manufacturing documentation including PFMEAs, Control Plans, SOPs, and Work Instructions in compliance with FDA and ISO 13485 requirements.

• Ensure processes are robust, scalable, and aligned with regulatory and quality standards.

Project Leadership & Continuous Improvement

• Lead cross-functional teams on process improvement, cost reduction, and capital equipment acquisition projects.

• Oversee equipment selection, installation, and validation activities (IQ/OQ/PQ).

• Collaborate with suppliers to establish process capability and ensure material and component quality.

• Drive operational excellence initiatives to enhance productivity and reduce manufacturing risk.

Mentorship & Technical Guidance

• Provide technical leadership and mentorship to junior engineers, technicians, and production staff.

• Support R&D through Design for Manufacturability (DFM) reviews and early-stage process development.

• Develop and deliver training on new equipment, tools, and manufacturing procedures.

• Foster a culture of accountability, innovation, and continuous learning.

Quality & Compliance

• Lead root cause analysis (RCA) investigations for production and quality issues using structured problem-solving tools.

• Drive CAPA initiatives and ensure timely, effective resolution of non-conformances.

• Maintain strict adherence to FDA regulations, ISO 13485 standards, and internal quality systems.

• Support internal and external audits as required.

________________________________________

Qualifications

Education

• Bachelor’s degree in Mechanical, Manufacturing, Biomedical, or related Engineering discipline.

• Advanced degree preferred.

 

Experience

• Minimum of 10+ years of experience in medical device manufacturing.

• Demonstrated experience in regulated environments (FDA, ISO 13485).

 

Technical Skills

• 5+ years of proficiency in CAD software (Creo and/or SolidWorks).

• Strong statistical analysis skills with Minitab or similar tools.

• Working knowledge of Lean Six Sigma principles (certification preferred).

• 3 to 5 years of experience with process validation (IQ/OQ/PQ) and DOE methodologies.

• 3 to 5 years of hands-on experience with molding, laser welding, bonding, or similar precision manufacturing processes

Thanks
Sid