Sr. Mechanical Design Engineer

Nihon Kohden Orange Med•Santa Ana, CA

1d•Hybrid

About The Position

The Senior Mechanical Design Engineer is responsible for independently leading and executing mechanical design and development activities for new and existing medical device products. This position applies advanced mechanical engineering expertise to the design, development, verification, and lifecycle support of high-reliability critical care medical devices. The Senior Mechanical Design Engineer will work closely with cross-functional teams to develop robust, manufacturable, and compliant product designs. The position is expected to exercise independent judgment, provide technical leadership within assigned projects, and ensure mechanical engineering activities are completed in accordance with applicable regulatory requirements and the company’s design control processes.

Requirements

Bachelor’s degree in mechanical engineering or a related engineering discipline; master’s degree preferred.
7+ years of progressive mechanical engineering design and development experience, including experience designing and developing products within the medical device or other highly regulated industry.
5+ years of hands-on experience with SolidWorks or comparable 3D CAD software, with demonstrated proficiency in complex mechanical design and product development.
Demonstrated experience in mechanical design of Plastic and Pneumatic components for use in Class 2 medical devices.
Demonstrated experience with design controls, design verification, and design validation within a regulated product development environment.
Experience developing and executing mechanical engineering verification testing, including test methods, protocols, reports, and analysis of results.
Working knowledge of FDA medical device requirements, ISO and IEC standards, and applicable quality system requirements.
Experience supporting regulatory documentation and submissions, including 510(k) submissions, where applicable.
Strong understanding and practical application of risk management principles in product design and development.
Strong knowledge of design for manufacturability (DFM), tolerance analysis, and GD&T principles.
Ability to evaluate mechanical designs for performance, reliability, safety, manufacturability, serviceability, and compliance with applicable requirements.
Strong analytical, problem-solving, decision-making, communication, and technical documentation skills.
Strong written communication skills, with the ability to prepare clear and concise technical summaries and reports, and excellent verbal communication skills.
Demonstrated ability to independently manage engineering activities, prioritize multiple projects, resolve technical challenges, and meet established project timelines.
Ability to effectively collaborate with Quality Assurance, Regulatory Affairs, Manufacturing, suppliers, and other cross-functional teams throughout the product development and lifecycle process.
Ability to provide technical guidance and mentorship to less experienced engineers and contribute to continuous improvement of engineering processes and practices.

Nice To Haves

master’s degree preferred

Responsibilities

Lead and execute mechanical design and development activities for medical device components, assemblies, and systems using SolidWorks and established engineering methodologies, including plastic, pneumatic, sheet metal, machined, molded, and other mechanical components.
Independently develop and maintain mechanical engineering documentation throughout the product lifecycle, including design specifications, drawings, engineering analyses, design reviews, change orders, and Design History File (DHF) records, in accordance with established design controls, FDA requirements, and applicable quality system procedures.
Conduct engineering analyses, calculations, simulations, prototyping, and testing to support design decisions and evaluate product performance, reliability, safety, manufacturability, serviceability, and compliance with applicable requirements.
Lead and execute design verification and validation activities, including development of test methods, protocols, reports, and analysis of results, while applying risk management principles to identify and mitigate design-related risks.
Collaborate with Quality Assurance, Regulatory Affairs, Manufacturing, suppliers, and other cross-functional teams to ensure mechanical designs and supporting documentation meet applicable regulatory and quality requirements and support regulatory submissions, including 510(k) submissions where applicable.
Provide technical leadership through design reviews, engineering changes, product improvements, and production support activities; proactively resolve technical challenges and provide recommendations based on sound engineering judgment.
Support investigation and resolution of production, supplier, quality, and field-related mechanical issues, including root cause analysis and implementation of corrective actions.
Provide technical guidance and mentorship to less-experienced mechanical engineers and contribute to the development of engineering best practices and processes.
Adheres to all company policies, procedures and business ethics codes.
Other duties as assigned.