Senior Engineer I – Electrical & Electronics (R&D Process & Product Design)

About the role

The Senior Engineer I – Electrical & Electronics provides sustaining engineering support for ophthalmic medical devices, ensuring product continuity, regulatory compliance, and performance throughout the product lifecycle. The role acts as a technical interface with cross‑functional teams such as software, design control, manufacturing, quality, and regulatory affairs.

Key responsibilities

• Provide subject‑matter expertise for electrical and electronic systems, including PCBAs, assemblies, wiring, power systems, sensors, and interfaces.
• Review and assess engineering changes (ECOs/ECNs) for risk, compliance, verification, and implementation readiness.
• Support design‑control activities: requirements definition, risk analysis, verification, and traceability.
• Perform root‑cause analysis and technical investigations for field, manufacturing, and service‑related electrical issues.
• Evaluate component changes, obsolescence, and supplier impacts; recommend technically sound solutions.
• Assess material compliance impacts (RoHS, REACH, regional regulations) associated with component and supplier changes.
• Ensure ongoing regulatory and quality compliance throughout the product lifecycle.
• Collaborate with mechanical, software, systems, manufacturing, quality, and regulatory teams to resolve complex issues.
• Provide engineering judgment, propose alternative solutions, and support technical file updates aligned with regional regulatory requirements.
• Assist product complaint investigations and update risk‑management reports as needed.

Required profile

• Bachelor’s degree in Electrical/Electronics Engineering or related discipline.
• Minimum 5 + years experience in medical‑device sustaining engineering or product development.
• Experience supporting embedded electronic systems.
• Familiarity with surgical or ophthalmic medical devices.
• Knowledge of ISO 13485, ISO 14971, IEC 60601 series, and electrical safety/EMC requirements.
• Ability to work independently with moderate autonomy while following defined processes.

Required skills

• PCB design and assembly expertise.
• Power‑systems and sensor integration.
• Use of PLM and requirements tools such as Windchill, Polarion, and Teamcenter.
• Root‑cause analysis and technical investigation.
• Evaluation of component obsolescence and regulatory compliance (RoHS, REACH).
• Embedded systems development.