Principal Mechanical Design Engineer

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A Day in the Life

The Principal Mechanical Engineer in Electrophysiology Technologies (EPT) serves as a recognized technical authority responsible for the architecture, design, verification, and lifecycle support of complex electromechanical systems used in cardiac mapping and ablation therapies. The role provides technical leadership across released product engineering and technology innovation, with a strong focus on patient safety, product reliability, regulatory compliance, risk management, and sustainable product performance.

Operating with a high degree of autonomy and ownership, the Principal Engineer identifies and drives technical priorities, provides direction across multiple programs, mentors engineers, and influences cross-functional decisions involving systems, firmware, electrical, mechanical, manufacturing, quality, regulatory, and supplier teams. The role is expected to anticipate risks, resolve ambiguity, make sound engineering decisions, and drive complex issues through implementation and closure.

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Primary Responsibilities

• Own and drive mechanical engineering activities for released products, from problem definition and technical assessment through design implementation, verification, release, and post-implementation monitoring.

• Develop and implement mechanical design improvements that enhance patient safety, product performance, system reliability, serviceability, and scalable manufacturing.

• Provide technical leadership for complex, ambiguous, or high-risk product and process issues; establish investigation strategies, make evidence-based decisions, and ensure actions are driven to effective closure.

• Lead cross-functional technical teams in investigating product and process issues, applying structured root-cause analysis to define, implement, and verify effective corrective and preventive actions.

• Apply sound engineering fundamentals, analytical methods, tolerance analysis, material selection, and design verification techniques to support robust mechanical solutions.

• Create and review 3D models, engineering drawings, specifications, technical reports, and presentations; ensure design outputs are complete, accurate, and suitable for release.

• Design, qualify, document, and maintain test fixtures, jigs, and tools, and provide technical oversight for associated testing activities.

• Lead or support test method development and validation, design verification and validation, and the interpretation and communication of results.

• Integrate risk-based decision-making and Design for Reliability and Manufacturability principles throughout design and development activities.

• Own timely, high-quality completion of applicable design control deliverables, technical reviews, product configuration activities, and engineering changes.

• Collaborate with program management, Manufacturing, Quality, Regulatory, Systems, Electrical, Firmware, and external suppliers on component selection, manufacturing processes, assembly methods, and product improvements.

• Investigate audit findings, process flows, and systemic gaps, and translate findings into practical, sustainable engineering improvements.

• Partner with Quality as a primary technical point of contact during internal and external audits and provide clear, evidence-based responses.

• Present technical findings, recommendations, risks, and project status clearly to cross-functional teams, senior management, and governance forums through design reviews, reports, presentations, and other appropriate communication channels.

• Mentor and technically develop engineers at multiple experience levels, reinforcing engineering rigor, mechanical design best practices, effective documentation, problem solving, and accountability.

• Influence engineering standards, design guidelines, platform strategies, and technology roadmaps within EPT.

• Represent mechanical engineering expertise in program reviews, technical escalations, and governance forums, and constructively challenge decisions when technical evidence or patient safety considerations warrant further action.

• Maintain current knowledge of relevant technologies, standards, industry practices, and emerging engineering methods, and apply that knowledge to improve products and processes.

• Travel to suppliers and design or manufacturing sites as required.

Required Knowledge and Experience

• Bachelor’s degree in mechanical engineering or a related engineering discipline with at least seven years of relevant experience; or a master’s degree with at least five years of relevant experience; or a PhD with at least three years of relevant experience.

• Demonstrated technical depth in the design, analysis, verification, and lifecycle support of complex mechanical or electromechanical products.

• Experience designing highly precise machined components, sheet-metal components, and mechanical assemblies.

• Proficiency with 3D CAD and engineering drawing tools, such as SolidWorks.

• Strong knowledge of metal and plastic materials, component manufacturing processes, tolerancing, assembly methods, and design for manufacturability.

• Knowledge of engineering change management, configuration control, and product lifecycle management tools such as Agile or Windchill.

• Demonstrated ability to lead complex technical work with limited direction, manage competing priorities, exercise sound judgment, and take ownership from problem identification through closure.

• Strong analytical and problem-solving skills, including structured root-cause analysis, technical risk assessment, and data-driven decision-making.

• Ability to communicate complex technical information clearly and influence decisions across functions and organizational levels.

• Demonstrated ability to collaborate effectively with cross-functional teams in a multinational matrix organization while maintaining accountability for technical outcomes.

Preferred Qualifications

• Experience in the medical device industry, particularly with safety-critical capital equipment or electromechanical systems.

• Working knowledge of medical device quality systems, design controls, and applicable standards and regulations, including 21 CFR Part 820 and ISO 13485.

• Experience with process validation and equipment qualification, including IQ, OQ, and PQ activities.

• Experience applying IEC 60601-1 requirements to medical electrical equipment.

• Experience with medical device labeling or symbol requirements, including ISO 15223-1.

• Experience with product risk management in accordance with ISO 14971.

• Experience conducting product or process investigations and supporting corrective and preventive actions (CAPAs).

• Experience providing technical leadership during audits, regulatory inspections, or complex quality-system investigations.

Physical Job Requirements

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.

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