As Sr. Principal Engineer and with minimal supervision, this role leads technical team members in the application of systems engineering and reliability engineering principles, methods, and techniques to bring new features to a medical device platform. Plans and leads project assignments in the evaluation, selection and adaptation of various techniques, procedures, and criteria with some guidance. Contributes to a Systems Engineering vision that aligns with the organization's vision and strategic plan. Utilizes solid understanding of engineering theory and best-practice in a variety of disciplines to manage complex projects or programs within boundaries of quality, time and budget. Provides direction to technical team members that are accountable for system engineering activities. Exhibits creativity and innovation in completing divisional and cross-functional/business unit goals and objectives.
Design, develop and implement product design for reliability plans.
Lead the planning, development and execution of reliability analysis and testing of new features (HW and SW) incorporated into an existing medical device platform.
Provide oversight and guidance to the development, documentation and execution of reliability verification.
Ensure appropriate trace-ability between system, subsystem, verification/validation and cross functional deliverables.
Manage the integration of deliverables from subsystem teams, cross functional teams (design, risk management, compliance, etc.) and external partners.
Resolve competing constraints between interrelated functions (Engineering, Risk Management, Compliance, Reliability, Clinical, Human Factors, Regulatory)
Collaborate with cross-functional resources (e.g. systems, hardware, Service, Mfg, Quality, etc.) involved in Reliability process activities.
Lead teams in establishing reliability predictions, reliability testing, and post-market measurements.
Support sustaining teams in Post Market events and Investigations.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. List knowledge, skills, and/or abilities required.
Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.
Experience/expertise in the following areas:
a. Test design, planning, execution, analysis and report writing; experience in designing or executing Accelerated Life Testing and/or Reliability Demonstration Testing preferred.
b. Familiarity with Mechanical and Electronic test fixture use/development and familiarity with mainstream data-logging equipment (e.g., NI Systems, Labview, etc.)
c. Familiarity with Design of Experiments
d. Familiarity with Reliability calculations and test design.
Must possess strong engineering knowledge and at least 6-8 years experience in electromechanical disciplines and design principles, preferably Medical Devices.
Requires strong systems engineering and critical thinking experience and ability.
Design For Reliability planning and management, establishing Reliability Requirements & Goals.
Reliability Prediction using Parts count & Parts stress method. Good understanding on standards like MIL-HDBK-217/ Telcordia and NPRD 95.
Reliability modeling & allocation to set the reliability target for subsystems and components.
Test design, planning, execution, analysis and report writing; experience in designing or executing Accelerated Life Testing and/or Reliability Demonstration Testing preferred.
Understanding of statistical techniques required for use in reliability analysis and test methods.
Ability to perform Weibull analysis on appropriate data sets.
Expertise and fluency in Excel, Minitab, Windchill/Relex, Reliasoft, etc. preferred.
Certified Reliability Engineer (or equivalent) preferred
Strong critical thinking skills.
Requires strong leadership behaviors and polished communication skills (e.g., solid technical writing of analyses, reports, test protocols; creation & delivery of leadership-level PowerPoint presentations).
Able to communicate effectively with both technical and non-technical personnel at multiple levels of the organization.
Able to work independently or with a cross-functional team.
Expertise with medical device development and / or Six Sigma Green Belt A Plus.
Education / Experience
BS in Mechanical, Manufacturing or Electrical Engineering required with approximately 5-8 years (4-6 years w/ MS) years of practical Electromechanical design experience.
Continuous Improvement Process
Six Sigma Methodology