Manufacturing Engineer (medical device)

Job details:

Job title:Manufacturing Engineer (medical device)

Location: Camarillo. CA

Long Term Contract

Job Description:

6+ years of experience in life sciences and medical device industries, excelling in New Product Introduction (NPI), process development, equipment validation (IQ/OQ/PQ), test method validation (TMVs) and continuous improvement in GMP, FDA, and ISO 13485 environments driving process efficiency and compliance.

EDUCATION

• M.S., Engineering preferred (but not required)
• B.S., Engineering Could be Biomedical, Mechanical, Industrial, Manufacturing, Aerospace

RELEVANT EXPERIENCE

Sr. Manufacturing Process Engineer New Product Introduction (NPI)

• Led process development and process optimization of semi-automated equipment using Design of Experiments (DOE), statistical analysis and control charts (Minitab) to improve yield by 23%
• Authored comprehensive technical documentation including URS, IQ/OQ/PQ, SOPs, MPIs, Engineering Reports, BOMs, and Work Instructions in support of GMP/FDA/ISO 9001 compliance
• Created and validated functional and destructive Test Methods; conducted Test Method Validation (TMV)-Attribute and Variable using Gage R&R to ensure high reliability and repeatability
• Executed Sterilization Validation (EO/Gamma) for subassembly level components per ISO standards and regulations
• Collaborated cross-functionally with R&D, Quality, Supply Chain, and Suppliers to develop material specifications for raw materials, subassemblies, and finished goods
• contributing to a 15% reduction in material non-conformances and improved first-pass yield.
• Designed tooling and fixtures in SolidWorks, driving production efficiency, cost reduction, and improved throughput by identifying bottlenecks and reduced scrap rate by 15%
• Managed facility expansion projects, performing impact/risk assessments, coordinating equipment calibration, preventive maintenance, and equipment qualification for seamless integration
• Supported DFM activities and Design Verification & Validation (V&V) builds for New Product Introductions (NPI), ensuring manufacturability and quality from concept through scale-up
• Spearheaded technology transfer of capital equipment that increasing operator efficiency by 30%, moving from single-pill to multi-pill packaging and managing validation activities
• Engineered and supported manufacturing of injection-molded plastic and silicone components by introducing and optimizing capital equipment, leveraging strong GD&T knowledge to interpret detailed mechanical drawings and ensure design intent
• Conducted and maintained pFMEAs, cycle time, and yield analyses, leading to a 20% reduction in equipment downtime
• Drove compliance by partnering with Quality to ensure GxP alignment; owned ECOs/DCOs for process changes via QMS-PLM (Arena)

TECHNICAL SKILLS

• Manufacturing & Quality: DOE, Gage R&R, SPC, ANOVA, TMV, GMP, IQ/OQ/PQ, CAPA, pFMEA, Aseptic Manufacturing, Root Cause Analysis (5 Whys, Fishbone), Sterilization (EO, Gamma), Injection Molding, Thermoforming, Serialization, Packaging
• Tools & Software: Microsoft Office, Minitab, JMP, SolidWorks, Visio, SAP ERP, MES, Arena, JIRA, Agile, Windchill, Microsoft ProjectMethods & System: Lean Manufacturing, Six Sigma (DMAIC), 5S, A3, 8D, PDCA, Gemba Walk, VSM
• Project & Program Management: Project Management, Team Management, Project Planning, Stakeholder Communication, Risk Management, Budget Management, RACI Matrice