Mechanical Engineer, Validation

Micro Systems Engineering Inc. (MSEI) is a pioneer in developing innovative implantable medical technologies that improveand often savethe lives of millions living with cardiovascular conditions and chronic neurologic pain. With over 45 years of expertise in designing and manufacturing active implantable devices our success is built on a foundation of core values: innovation quality reliability integrity teamwork and deep technical excellence. These principles drive our global reputation for trust and confidence among physicians and patients alike. Were always seeking passionate engineers scientists technicians and professionals to help advance our mission and shape the future of medical technology.

Please join us as:

Mechanical Engineer Validation

Your Responsibilities

• Collaborate with crossfunctional teams to review mechanical designs and requirements.
• Develop comprehensive V&V test plans for new products and production improvements ensuring alignment with quality system requirements.
• Author test protocols for formal V&V tests to ensure consistency ahead of and during testing.
• Design construct and qualify mechanical and electrical bench test fixtures.
• Lead test method validation effort to demonstrate measurement and operator repeatability using statistical tools.
• Execute formal design verification testing using industry standard and custom-built test equipment.
• Author concise test reports clearly documenting the methods employed and results obtained.
• Work with regulatory department to author overall descriptions of test methods / results in support of FDA submissions.
• Create and maintain testing timelines for communication of status to management.
• Support FMEA tolerance stack-up analysis and failure analysis as bandwidth permits.
• Work with external vendors on outsourced projects to ensure any verification activities performed meet expectations of MSEI quality management system.
• Ensure compliance with FDA EU MDR and ISO standards.

Required Qualifications

• Bachelors degree in mechanical or biomedical engineering; MS preferred.
• 4 years experience in mechanical verification and validation (V&V) testing of medical or highreliability devices.
• Well rounded experience in mechanical / electrical fixture design test development and statistical analysis of results.
• Handson experience with mechanical (i.e. tensile testers) and electrical (LCR oscilloscope etc.) test equipment.

• Experience in the fabrication and rework of mechanical test fixture components using 3D printing milling laser welding saws drills etc.

• Knowledge of failure modes and effects analysis (FMEA) and application in product design.
• Must be a proficient CAD user (Solidworks preferred).
• Experience evaluating measurement systems through Gage R&R bias linearity stability and other MSA methods.
• Demonstrated ability to lead crossfunctional projects.
• Exceptional technical documentation skills; produces clear accurate and audit-ready documentation.

Preferred Qualifications

• 10 years of experience in verification of implantable medical devices.
• Experience in the design and testing of neuromodulation implantable components.
• Handson experience with automated test fixture development including programming (C# preferred).
• Knowledge of project management tools and methodologies.
• Experience applying formal riskmanagement principles throughout the product lifecycle.

PHYSICAL REQUIREMENTS

The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• While performing the duties of this job the employee is regularly required to be independently mobile.
• The employee is also required to interact with a computer for extended periods of time and communicate with co-workers