Mechanical Design Engineering Manager

Nihon Kohden Orange Med•Santa Ana, CA

2d•Hybrid

About The Position

The Mechanical Design Engineering Manager serves as a critical leader within the R&D organization, responsible for leading, developing, and directing the mechanical engineering team. This role oversees the design, development, validation, and lifecycle management of mechanical systems and components for new and existing medical device products. The ideal candidate combines strong mechanical engineering expertise with proven leadership skills to effectively manage a team, drive innovation, and deliver high-quality engineering solutions in a regulated medical device environment.

Requirements

Bachelor’s degree in mechanical engineering or related discipline; master’s degree preferred.
Minimum of 10 years of mechanical engineering design and development experience, with 3-5 years of demonstrated engineering leadership or people management experience.
Minimum of 10 years of experience designing mechanical systems, components, and assemblies using SolidWorks or similar CAD platforms.
Proven experience leading complex mechanical design projects from concept through product release and sustaining engineering support.
Extensive experience with mechanical design and development of plastic components, pneumatic systems, and precision mechanical assemblies used in high-reliability medical devices.
Experience developing and supporting Class II and Class III medical devices, preferably within critical care or life-support applications.
Strong knowledge of FDA Design Controls, ISO 13485 quality systems, IEC standards, and regulatory requirements applicable to medical device development and 510(k) submissions.
Experience developing and executing mechanical verification and validation testing strategies, including test planning, protocol development, execution, and documentation.
Strong understanding of mechanical design documentation requirements, including drawings, specifications, risk assessments, design reviews, and regulatory submission support documentation.
Demonstrated ability to lead technical investigations, perform root cause analysis, and implement effective corrective and preventive actions.
Strong analytical, organizational, project management, and problem-solving skills with the ability to make sound technical decisions based on engineering analysis and data.
Demonstrated ability to lead, mentor, and develop engineers across various experience levels and disciplines.
Excellent written, verbal, and interpersonal communication skills with the ability to effectively communicate technical information across all levels of the organization.

Nice To Haves

Master's degree preferred.

Responsibilities

Lead, manage, and develop a team of mechanical engineers and technicians responsible for the design, development, and sustaining engineering activities of medical device products.
Provide technical leadership and guidance throughout the product development lifecycle, including concept development, mechanical architecture, design reviews, prototyping, verification and validation, product release, and post-market support.
Establish and promote mechanical engineering best practices, design methodologies, engineering standards, and development processes to improve product quality, efficiency, and reliability.
Provide expertise in mechanical system architecture, component selection, tolerance analysis, material selection, subsystem integration, design verification, manufacturability, reliability engineering, and lifecycle management.
Lead mechanical design and development activities in accordance with applicable FDA Design Control requirements, ISO standards, IEC requirements, and medical device regulatory expectations for Class II and Class III products.
Manage engineering projects and resources by defining priorities, allocating team capacity, establishing project schedules, and ensuring timely completion of deliverables.
Drive continuous improvement initiatives focused on engineering processes, design methodologies, development workflows, documentation practices, and engineering tools.
Provide technical leadership in resolving complex product issues through structured problem-solving, root cause analysis, corrective actions, and risk-based decision-making.
Partner with Quality Assurance, Regulatory Affairs, Manufacturing, Operations, Supply Chain, and other cross-functional teams to support product development, regulatory submissions, design transfers, sustaining activities, and product improvements.
Support the creation, review, and maintenance of mechanical engineering documentation required for regulatory submissions, product registrations, design history files (DHF), and technical files.
Mentor, coach, and develop engineering team members by providing technical guidance, feedback, and opportunities for professional growth.
Adheres to all company policies, procedures and business ethics codes.
Perform other duties as assigned.