Manufacturing Engineer - FDA/ISO

Manufacturing Engineer – FDA/ISO

Location: On-Site in Spring Hill, FL and Dunedin, FL

Are you a detail-driven Manufacturing Engineer who thrives in highly regulated environments and takes pride in building processes that stand up to FDA and ISO scrutiny? 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.
• Oversee First Article Inspection activities and ensure complete traceability and documentation accuracy.
• 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.
• Investigate nonconforming material trends, lead root cause analysis efforts, and define effective rework strategies.
• 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.
• Collaborate cross-functionally to reduce waste, improve yield, and enhance operational efficiency.
• Drive initiatives that strengthen process robustness and long-term regulatory compliance.

Required Qualifications

• Bachelor’s degree in mechanical engineering, Manufacturing Engineering, Biomedical Engineering, or related technical field.
• 3 to 5 years of experience in an FDA-regulated manufacturing environment, medical device experience strongly preferred.
• Demonstrated expertise with ISO 13485 quality systems.
• 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.

If you are ready to take ownership of manufacturing process integrity within a growing medical device organization, we would welcome the opportunity to speak with you.

About Blue Signal:

As an award-winning executive search firm, Blue Signal has a strong track record of placing top talent in the manufacturing & industrial space, with expertise in manufacturing leadership, engineering, supply chain, and logistics roles. Leare more at bit.ly/3D3a7NH