Manufacturing & Validation Engineer - Process & Compliance Lead

Blue Signal Search; Spring Hill (FL); On-site; USD 90,000 - 120,000; Full time

Job summary

Blue Signal Search is seeking a Manufacturing & Validation Engineer to lead compliance-driven manufacturing initiatives in Spring Hill and Wesley Chapel, FL. The role focuses on validation strategy, process development, and cross-functional collaboration to ensure audit-ready production environments.

The candidate will own documentation, drive IQ/OQ/PQ programs, and support CAPA and continuous improvement in a two-site medical device setting.

Qualifications

• Bachelor’s degree in engineering or related field required.
• 3–5 years in FDA-regulated manufacturing, medical device experience preferred.
• Strong knowledge of quality/compliance requirements and documentation ownership.
• Experience leading/participating in IQ/OQ/PQ validations.
• Familiarity with PFMEA, FAI, PPAP, SPC, and CAPA processes.
• CAD software proficiency (SolidWorks) and ERP system experience.

Responsibilities

• Develop and maintain manufacturing routers, work instructions, and SOPs for controlled production environments.
• Create and manage process flow diagrams and FMEA to mitigate risk.
• Lead and support equipment and process validations (IQ/OQ/PQ).
• Lead First Article Inspection and ensure end-to-end traceability.
• Collaborate with Quality to establish PPAP documentation and CAPA plans.
• Improve tooling and fixtures, using CAD (SolidWorks) when needed.

Skills

Attention to detail

Documentation & writing

Cross-functional collaboration

Education

Bachelor’s degree in engineering

Tools

SolidWorks

ERP systems

Job description

Blue Signal Search is seeking a Manufacturing & Validation Engineer to lead compliance-driven manufacturing initiatives in Spring Hill and Wesley Chapel, FL. The role focuses on validation strategy, process development, and cross-functional collaboration to ensure audit-ready production environments.

The candidate will own documentation, drive IQ/OQ/PQ programs, and support CAPA and continuous improvement in a two-site medical device setting.