Senior Medical Device Process & Validation Engineer

Innovative Health LLC; Scottsdale (AZ); Vor Ort; USD 110.000 - 170.000; Vollzeit

Zusammenfassung

Innovative Health LLC seeks a Senior Manufacturing Engineer to lead design, validation, and optimization of medical device manufacturing processes. The role emphasizes regulatory compliance (GMP/ISO 13485), continuous improvement, and cross-functional collaboration for NPI and scale-up.

You will drive process validation studies, analyze CAPA data, and mentor junior engineers in a fast-paced, regulated environment.

Qualifikationen

• Bachelor's degree in Mechanical/ Biomedical/ Chemical Engineering or related field; Master’s preferred.
• 5+ years of experience in a regulated medical device manufacturing environment.
• Strong knowledge of GMP, ISO 13485, and FDA regulations.
• Proven track record in process validation, root cause analysis, and CAPA closing.
• Experience with automation, assembly or testing equipment in cleanroom/controlled manufacturing.
• Proficient with engineering tools (SolidWorks, Minitab, JMP) and ERP/MES systems.

Aufgaben

• Lead process design, development, and optimization for medical device manufacturing with compliance.
• Drive continuous improvement using lean, Six Sigma, and SPC tools.
• Collaborate with R&D, Quality, Regulatory for product transfers, scale-up and validation (IQ/OQ/PQ).
• Develop and implement process validation protocols and studies for new/existing processes.
• Analyze manufacturing data to identify trends, root causes, and CAPA actions to improve yield and reduce scrap.
• Support equipment selection, qualification, and maintenance planning for critical operations.
• Provide technical leadership on NPI and design for manufacturability (DFM).
• Mentor junior engineers and manufacturing staff.

Kenntnisse

Leadership

Communication

Project management

Regulatory awareness

Ausbildung

Bachelor's in engineering (Biomedical/Mechanical/Chemical)

Tools

SolidWorks

Minitab

JMP

ERP/MES systems

Jobbeschreibung

Innovative Health LLC seeks a Senior Manufacturing Engineer to lead design, validation, and optimization of medical device manufacturing processes. The role emphasizes regulatory compliance (GMP/ISO 13485), continuous improvement, and cross-functional collaboration for NPI and scale-up.

You will drive process validation studies, analyze CAPA data, and mentor junior engineers in a fast-paced, regulated environment.