Senior Mechanical Engineer

About the Position

Endospan is looking for an experienced and hands-on Senior Process Engineer to join its Engineering Department.

The Senior Process Engineer will lead the development, implementation, validation, and continuous improvement of manufacturing processes for class III medical devices and implants. The role includes production support, process and equipment development, fixture design, preparation of technical drawings, process validation, troubleshooting, and implementation of engineering improvements.

The position requires close collaboration with R&D, Production, Quality Assurance, Quality Control, Regulatory Affairs, Supply Chain, and external suppliers.

Key Responsibilities

• Develop, implement, optimize, and maintain manufacturing and assembly processes for medical devices and implants.
• Design and develop fixtures, jigs, tools, and manufacturing aids to support production and inspection processes.
• Prepare detailed technical drawings and manufacturing documentation for medical implants, components, fixtures, and tools in accordance with applicable standards.
• Use advanced CAD tools, primarily SolidWorks, for product, tooling, fixture, and process-support design.
• Define process parameters, operating ranges, acceptance criteria, and in-process controls.
• Provide hands-on engineering support to production and resolve technical issues affecting product quality, yield, capacity, or delivery.
• Investigate process failures, deviations, nonconformities, and recurring production problems.
• Identify and implement improvements in process robustness, repeatability, yield, cycle time, ergonomics, cost, and production efficiency.
• Support new product introduction, design transfer, production scale-up, and manufacturing-readiness activities.
• Support supplier qualification, process transfer, and manufacturing activities performed by subcontractors and external manufacturing partners.
• Work with suppliers to improve process robustness, manufacturing capacity, scalability, quality, and delivery performance.
• Lead cross-functional engineering projects from planning through implementation.

Position Requirements

• Bachelor’s degree in Mechanical Engineering or Biomedical Engineering.
• At least 10 years of experience in process engineering, manufacturing engineering, mechanical design, or industrialization.
• At least 3 years of experience in mechanical design and preparation of detailed technical drawings.
• Demonstrated experience designing fixtures, jigs, tools, or production equipment.
• Strong experience using CAD software, preferably SolidWorks.
• Experience developing, implementing, and validating manufacturing processes.
• Experience with production support, troubleshooting, root-cause analysis, and implementation of corrective actions.
• Ability to prepare clear, accurate, and controlled technical and manufacturing documentation.
• Ability to independently manage multiple projects and priorities.
• Hands-on approach and willingness to work directly with production personnel, equipment, tooling, and products.
• Strong teamwork, creativity, initiative, and interpersonal communication skills.
• High-level written and spoken English.

Preferred Qualifications

• Experience in the medical-device industry.
• Experience with Class III, implantable, catheter-based, or other complex medical devices.
• Experience working in an ISO 13485-compliant quality system.
• Familiarity with FDA and European medical-device regulatory requirements.
• Experience with design transfer, NPI, manufacturing scale-up, and process validation.
• Experience with cleanroom manufacturing and controlled-environment processes.
• Experience with manual assembly, suturing, bonding, welding, crimping, heat treatment, cleaning, or packaging processes.
• Experience working with external manufacturers and international suppliers.

Why Join Endospan?

Endospan offers a unique opportunity to join an innovative medical-device company developing advanced implantable technologies.

The position provides the opportunity to take technical ownership of critical manufacturing processes, work on complex engineering challenges, influence product quality and production scalability, and grow professionally in a dynamic and collaborative environment.

Interested?

Please send your CV to [email protected] and join us in shaping the future of medical engineering.

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Responsibilities

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