Staff Product Engineer

At Siemens Healthineers, we are passionate about enabling healthcare professionals to deliver high quality patient care, and to do so affordably.  A leading global healthcare company, Siemens Healthineers continues to strengthen our portfolio of medical imaging and laboratory diagnostics, while adding new offerings such as managed services, consulting, and healthcare IT services – as well as further technologies in the growing market for therapeutic and molecular diagnostics.

Siemens Healthineers develops innovations that support better patient outcomes with greater efficiencies, giving providers the confidence they need to meet the clinical, operational and financial challenges of a changing healthcare landscape.

The Sr. Product Engineer will help the team design, develop and commercialize new Point of Care products. The talented and passionate individual will be responsible for Integrating, analyzing, testing, and documenting electromechanical components and systems for medical diagnostic instruments. In addition to technical expertise, this person will bring strong leadership and team building skills and foster an environment of growth and personal development.

Duties & Responsibilities

• Demonstrates proficiency in performing root cause analysis and initiating and leading troubleshooting activities. This person leads activities related to failure mode and error analysis of a next generation type II medical device.

·        Leads the development of test plans and data acquisition in support of ongoing product development as well as informal (dry run) and formal (design V&V) testing of complex electro-mechanical, software-driven medical devices; responsibilities may include managing systems HW& SW integration, software loads and updates, configuration control, and test execution and reporting.

·        Works with subsystem teams, domain subject matter experts, and suppliers in the identification, logging, assessment, and resolution of integration and test issues.

·        Specify, design, and develop test systems (hardware & software); ensure that all test systems and equipment are appropriately validated and controlled

·        Collaborates with a diverse technical team to create, update, and maintain documentation that is or will become part of the product design history file (DHF) for a medical instrument.

·        Work closely with all engineering disciplines, including Systems, Electrical, Mechanical, Disposables, and Software Engineering, as well as Project Management and Quality personnel, to verify and validate product designs.

·        Applies knowledge of regulations and standards including: FDA design controls, ISO 9000, ISO 13485, IEC 62304, IEC 60601, and ISO 14971.

·        Perform design reviews, FMEA’s, risk / hazard analysis, establish technical requirements

Knowledge & Skills:

·        Minimum BS in Engineering (Biomedical, Mechanical or Software ) is required  + 5 years of relevant experience

·        Electro-mechanical product design experience throughout the design life cycle is required

·        Experience with application of fluid dynamics, heat transfer, electronics & programming are required

·        Adapts to change quickly and is able to multi-task, managing several activities or projects simultaneously.

·        Demonstrates technical confidence to interact with engineers of other disciplines, supports technical discussions, and demonstrates the ability to make technical decisions

·        Ability to understand complex system interactions and the effect on analytical performance

·        Proficiency with data acquisition, analysis and statistical techniques using Labview, MatLab, Minitab etc. Expert competency with LabVIEW is a plus

·        Experience in fluidics and designing small fluidic systems

·        Demonstrated understanding of product development considerations for tightly controlled manufacturing processes

·        Clear understanding of product and process validation including V&V, TMV, FAI, FAT/SAT IQ/OQ/PQ etc.

·        Excellent understanding of medical device product development risk management methodologies

·        Knowledge of Design of Experiments (DOE), Design for Six Sigma (DFSS), Design for Manufacturing/Assembly (DFMA)

·        Ability to produce quality written work, such as, technical reports, protocol and plans.

·        Ability to clearly communicate ideas and knowledge (upward and downward) to other individuals and teams - both in writing and verbally

·        Basic understanding of IP considerations

·        Experience with ISO requirements and GMP guidelines, FDA regulations, medical device design control, and manufacturing scale up processes

Additional Preferred Qualifications:

• Familiarity with materials used in medical devices (best practices, biocompatibility)

• Specialty technical expertise for use of Computational Modeling and Simulation tools for fluid or structural/solid mechanics

• Hands-on ability to work on test method development, fixture development, prototype assembly, preliminary concept generation testing/evaluation

#LI-EM1