Mechanical Sustaining Engineer

Siemens Healthineers

About The Position

Join us in pioneering breakthroughs in healthcare. For everyone. Everywhere. Sustainably. Our inspiring and caring environment forms a global community that celebrates diversity and individuality. We encourage you to step beyond your comfort zone, offering resources and flexibility to foster your professional and personal growth, all while valuing your unique contributions. As a Mechanical Sustaining Engineer, you will be responsible for ensuring product quality, reliability, and continuous improvement across the product lifecycle. You will drive root‑cause investigation, support manufacturing and supply chain activities, manage design changes, and uphold regulatory compliance while collaborating closely with cross‑functional teams. Your Expertise: Strong mechanical engineering fundamentals. Hands‑on problem‑solving capability. Experience working in regulated medical device or high‑reliability product environments. Ability to diagnose and resolve field issues. Skilled in executing design updates and improvements. Capable of supporting production and addressing manufacturing challenges. Proven ability to drive improvements in performance, reliability, and cost.

Requirements

Bachelor’s degree in mechanical engineering or related field (Master’s preferred).
3+ years of experience in sustaining engineering, product development, or manufacturing engineering (medical device experience highly preferred).
Proficiency in 3D CAD tools (CREO preferred).
Experience with ECO/ECR processes within a controlled QMS environment.
Strong understanding of root‑cause analysis tools (5 Whys, Ishikawa, DOE, etc.).
Hands‑on experience with V&V testing and test fixture development.
Knowledge of FDA QSR, ISO 13485, and regulated product development processes.
Understanding of mechanical design fundamentals, GD&T, tolerance stack‑ups, and materials.
Strong problem‑solving skills and ability to work cross‑functionally.
Excellent communication and documentation skills.
Up to 10–20% travel required for supplier visits, field investigations, and manufacturing support.

Responsibilities

Field Issue Resolution Investigate and resolve product failures, customer complaints, and CAPA/NCR actions. Perform root cause analysis and implement effective corrective actions.
Design Change Management Create and update CAD models and drawings (CREO preferred). Prepare and process Engineering Change Orders (ECO/ECR) within QMS systems.
Testing and Validation Develop test protocols and fixtures. Conduct verification and validation testing (thermal, vibration, durability, biocompatibility).
Supply Chain & Manufacturing Support Manage BOM updates and identify end‑of‑life components. Validate alternate components and support supplier process improvements. Support manufacturing transfers and assist with production troubleshooting. Lead development of production tooling/molds together with R&D engineers.
Regulatory Compliance Ensure adherence to FDA QSR, ISO 13485, and other applicable industry standards. Maintain documentation for audits and regulatory submissions.
Cost Reduction & Reliability Apply DFx principles to improve product reliability and reduce cost.
Cross‑Functional Collaboration Partner closely with R&D, Reliability Engineering, Quality, Manufacturing, Regulatory Affairs, and Supply Chain teams.