Manufacturing & Validation Engineer

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

Location: On-Site in Spring Hill, FL and Wesley Chapel, FL

Are you a quality-focused Manufacturing & Validation Engineer who excels in compliance-driven settings and knows how to develop robust manufacturing systems that consistently meet FDA and ISO requirements? A rapidly growing medical device manufacturer in the Tampa Bay region is expanding its engineering team and seeking a hands‑on leader to strengthen process integrity, validation execution, and production readiness across two Florida facilities.

This is a high-impact role for someone who enjoys owning documentation, driving validation strategy, and partnering cross-functionally to ensure manufacturing operations are audit-ready, efficient, and scalable. You will serve as the critical bridge between Engineering and Production, helping bring complex medical products from design into robust, compliant manufacturing environments.

Why This Role

This position is ideal for an engineer who values structure, compliance, and precision while still enjoying collaboration on the production floor. You will play a central role in strengthening systems that directly impact product quality, regulatory success, and patient outcomes.

Key Responsibilities

Process Development and Regulatory Documentation

• Develop and maintain manufacturing routers, work instructions, and standard operating procedures that support controlled production environments.
• Create and manage process flow diagrams and Process Failure Mode and Effects Analyses to proactively mitigate risk.
• Lead and support equipment and process validations including Installation Qualification, Operational Qualification, and Performance Qualification.
• Lead First Article Inspection efforts while maintaining accurate records and end-to-end traceability.
• Partner with Quality to establish and maintain Production Part Approval Process documentation.
• Evaluate and improve tooling and fixtures, designing new solutions using CAD tools such as SolidWorks when needed.

Quality Systems and Compliance

• Design and implement incoming inspection protocols for raw materials and components.
• Analyze patterns in material defects, identify underlying causes, and develop practical corrective and rework solutions.
• Contribute to CAPA efforts and assist in maintaining compliance for internal and external audit processes.
• Conduct and analyze Statistical Process Control studies to monitor process stability and drive measurable improvements.

Production Support and Continuous Improvement

• Train production personnel on new procedures, documentation updates, and equipment changes.
• Provide technical troubleshooting support to resolve manufacturing challenges and improve capability.
• Support cross-functional initiatives focused on process improvement and operational performance.
• Drive initiatives that strengthen process robustness and long‑term regulatory compliance.

Required Qualifications

• Bachelor’s degree in a relevant technical or engineering‑related discipline.
• 3 to 5 years of experience in an FDA‑regulated manufacturing environment, medical device experience strongly preferred.
• Working knowledge of industry quality and compliance requirements.
• Hands‑on experience leading or supporting IQ, OQ, PQ validations.
• Working knowledge of PFMEA, FAI, PPAP, SPC, and CAPA processes.
• Proficiency with CAD software and ERP systems.
• Strong documentation ownership and technical writing skills.

Preferred Qualifications

• Experience with statistical analysis tools such as Minitab.
• Background supporting internal or external ISO or FDA audits.
• Experience balancing documentation‑heavy responsibilities with hands‑on production floor engagement.