Senior Product Engineer

Key Responsibilities

• Own the technical performance and integrity of the Design History File (DHF) for assigned ultrasound transducer products, ensuring alignment and sustainment throughout the product lifecycle.
• Serve as the primary engineering point of contact for install base health, reliability, and design-driven manufacturability.
• Drive prioritization of issues based on customer impact, risk, and business needs.
• Define, scope, and execute Engineering Change Requests (ECRs) and Engineering Change Orders (ECOs).
• Evaluate design, process, and supplier changes for impact on patient safety, quality, cost, and the installed base.
• Drive cross-functional alignment and approvals for changes.
• Ensure robust documentation, qualification, and implementation of changes.
• Lead and support non-conformances (NCs), investigations (INVs), and corrective and preventive actions (CAPAs).
• Perform root cause analysis and ensure effective corrective and preventive actions are implemented.
• Partner with Quality and Regulatory teams.
• Support audits, inspections, and post-market surveillance activities.
• Support supplier-related investigations and technical issue resolution.
• Evaluate, qualify, and approve Supplier Change Requests (SCRs).
• Collaborate with Supplier Quality and Sourcing on supplier performance improvement.
• Provide technical guidance for component selection, obsolescence management, and redesign.
• Lead cross-functional problem-solving efforts across engineering, quality, manufacturing, supply chain, and service.
• Influence decision-making without direct authority.
• Act as the voice of the install base in design and strategic discussions.

Required Qualifications

• Bachelor’s degree in Electrical Engineering, Mechanical Engineering, Biomedical Engineering, or a related field.
• 6 years of experience in product engineering, manufacturing engineering, or sustaining engineering.
• Experience troubleshooting product issues and driving root cause analysis.
• Experience with structured problem solving and engineering change management (ECR/ECO).
• Experience supporting quality investigations (CAPA, NCs, complaints).
• Proven ability to operate in cross-functional engineering environments.
• Strong systems-level thinking and analytical capability.

Preferred Qualifications

• Experience in design, manufacturing, or sustaining engineering of medical devices.
• Familiarity with ultrasound transducers or similar electromechanical systems.
• Understanding of design controls and post-market surveillance.
• Experience working with suppliers in global manufacturing environments.
• Experience with supplier change requests and component qualification.
• Familiarity with FDA (21 CFR Part 820) and ISO 13485.