Medical Device Manufacturing Engineer I

THE ALFRED E MANN FOUNDATION FOR SCIENTIFIC R; Santa Clarita (CA); Sur place; USD 85 000 - 92 000; Plein temps

Avantages offerts par ce poste

9/80 schedule with every other Friday

Weekly team traditions

Monthly lunches

Quarterly events

9/80 schedule

Résumé du poste

The Alfred Mann Foundation for Scientific Research in Santa Clarita, CA is seeking a Manufacturing Engineer I to support the development, transfer, and production of implantable medical devices. You will work with cross‑functional teams to ensure processes are efficient, scalable, and compliant with regulatory requirements.

Responsibilities include partnering with R&D, performing process validation, and maintaining manufacturing documentation.

Qualifications

• Bachelor's degree in Mechanical Engineering, Manufacturing Engineering, Biomedical Engineering, Materials Engineering, or a related engineering discipline.
• 1+ years of engineering experience through industry experience, internships, co‑ops, or equivalent hands‑on experience.
• Experience supporting manufacturing processes, process improvement initiatives, or product development activities.
• Ability to read and interpret engineering drawings and CAD models.
• Experience using SolidWorks, AutoCAD, or similar CAD software.
• Understanding of process validation, risk management, and manufacturing documentation practices.
• Proficiency with Microsoft Office applications including Excel, Word, PowerPoint, and Outlook.
• Strong analytical, troubleshooting, and problem‑solving skills.
• Excellent written and verbal communication skills.
• Highly organized, self‑motivated team player with strong attention to detail.

Responsabilités

• New Product Introduction (NPI) & Process Development: Partner with R&D teams to support product development, design transfer, and manufacturing readiness activities.
• New Product Introduction (NPI) & Process Development: Develop, validate, and improve manufacturing processes for implantable medical devices and systems.
• New Product Introduction (NPI) & Process Development: Support process validation activities including IQ, OQ, and PQ protocols and reports.
• New Product Introduction (NPI) & Process Development: Develop and maintain manufacturing documentation including SOPs, work instructions, PFMEAs, and process specifications.
• New Product Introduction (NPI) & Process Development: Support product and process transfers to suppliers, contract manufacturers, and remote manufacturing sites.
• New Product Introduction (NPI) & Process Development: Evaluate and qualify new materials, equipment, tooling, and suppliers.
• Manufacturing & Production Support: Support manufacturing operations and production builds through hands‑on engineering support.
• Manufacturing & Production Support: Troubleshoot manufacturing, equipment, and process‑related issues using root cause analysis techniques.
• Manufacturing & Production Support: Assist with production planning, workflow optimization, and manufacturing efficiency improvements.
• Manufacturing & Production Support: Analyze production data and process metrics to identify opportunities for performance improvements.
• Manufacturing & Production Support: Support manufacturing teams in executing work orders, tracking build progress, and resolving obstacles.
• Sustaining Engineering & Continuous Improvement: Drive continuous improvement initiatives focused on quality, yield, reliability, and cost reduction.
• Sustaining Engineering & Continuous Improvement: Support corrective and preventive actions (CAPA) related to manufacturing processes and equipment.
• Sustaining Engineering & Continuous Improvement: Optimize manufacturing layouts, workflow, resource utilization, and equipment performance.
• Sustaining Engineering & Continuous Improvement: Support preventative maintenance activities and equipment reliability programs.
• Sustaining Engineering & Continuous Improvement: Design, develop, and implement tooling, fixtures, and manufacturing solutions to improve productivity.
• Quality & Compliance: Ensure compliance with GMP, ISO 13485, FDA QSR, and company procedures.
• Quality & Compliance: Support internal and external audits by preparing documentation and representing manufacturing engineering activities.
• Quality & Compliance: Participate in risk management, process control, and quality improvement initiatives.
• Quality & Compliance: Collaborate with Quality Assurance and Supply Chain teams to support compliant manufacturing operations.

Connaissances

Analytical skills

Troubleshooting

Communication skills

Attention to detail

Team player

MS Office

Formation

Bachelor's degree in Mechanical Engineering, Manufacturing Engineering, Biomedical Engineering or Materials Engineering

Outils

SolidWorks

AutoCAD

Description du poste

The Alfred Mann Foundation for Scientific Research in Santa Clarita, CA is seeking a Manufacturing Engineer I to support the development, transfer, and production of implantable medical devices. You will work with cross‑functional teams to ensure processes are efficient, scalable, and compliant with regulatory requirements.

Responsibilities include partnering with R&D, performing process validation, and maintaining manufacturing documentation.