Principal Development Engineer
Corindus, Inc.

Join us in pioneering breakthroughs in healthcare. For everyone. Everywhere. Sustainably.

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Apply now for the position of Principal Development Engineer. This position is located in Newton, MA.

Siemens Healthineers Company, Endovascular Robotics (EVR) division, is a global technology leader in robotic-assisted vascular interventions. The company's CorPath® system is the first FDA-cleared medical device to bring robotic-assisted precision to neurovascular, percutaneous coronary and peripheral interventions. EVR is advancing the field of interventional medicine with robotics through improvements to procedural control, precision, and workflow.




Position Summary:

The Principal Development Engineer will be a part of the R&D organization and an important contributor to the realization of the next generation robotic platform that will change the future of healthcare. You will be a highly visible technical resource working on the transition of complex electro-mechanical assemblies from requirement establishment, requirement refinement and traceability matrices in close collaboration with system engineering, technical leads, Supply Chain & Manufacturing, and other functions. This role is suited for an established, ambitious R&D engineer with a strong track record of complex electro-mechanical medical devices development, design transfer and product launch. You will have a great opportunity to lead requirements refinement process, define verification approach, support development of verification fixtures, and support development of test protocols that paves the path to successful Verification and Validation activities, clinical trials, followed by launch.




Key Responsibilities:

• Being a crucial team member working on system, subsystem, and lower-level requirements

• Lead readiness of requirements and refinement process for subsystem and lower-level as well as interface requirements for verification

• Support establishment of traceability matrices for all levels of requirements

• Allocate, decompose, and translate typical medical device industry standards into requirements

• Support improvement of verification and validation strategy for program

• Develop system test architectures, verification, and validation strategies, and identify levels of resources, in terms of personnel, budget, schedule, and facilities, to accommodate various test efforts including analysis, inspection, demonstration, and test

• Work closely with existing tech leads and jointly generate the appropriate requirements to represent as well as communicate effectively with suppliers, customers, and teammates

• Develop and maintain the system requirements specification for the project with emphasis on subsystem functions and interfaces

• Author/co-author relevant documents such as verification and validation plans, test protocols, test methods, test reports, analyses, and system documentation

• Support a variety of multi-disciplinary technical and process improvement projects of different sizes and scopes

• Lead, manage and communicate assigned projects in collaboration with cross-functional teams




Qualifications :

• Minimum of 12 years electromechanical R&D engineering experience, preferably in medical device industry
• Bachelor's degree in Mechanical, Mechatronics, or Robotics Engineering is required. Advanced degree is a plus.
• Experience in managing engineering projects
• Must have Solidworks/PDM proficiency
• LabVIEW and MATLAB Simulink proficiency desired
• Must have previous experience launching complex medical devices

• Must have strong technical and analytical abilities including DOE, FMEA, and statistical analysis

• Must be proficient in design verification and validation of medical devices
• Must be proficient in medical device design control

• Must have knowledge of compliance and regulatory requirements

• Able to execute multiple assigned projects and duties with minimal supervision
• Must be a self-starter with strong leadership skills and deep technical competencies
• Outstanding documentation and communication skills required

Who we are:
We are a team of more than 71,000 highly dedicated Healthineers in more than 70 countries. As a leader in medical technology, we constantly push the boundaries to create better outcomes and experiences for patients, no matter where they live or what health issues they are facing. Our portfolio is crucial for clinical decision-making and treatment pathways.

How we work:
When you join Siemens Healthineers, you become one in a global team of scientists, clinicians, developers, researchers, professionals, and skilled specialists, who believe in each individual's potential to contribute with diverse ideas. We are from different backgrounds, cultures, religions, political and/or sexual orientations, and work together, to fight the world's most threatening diseases and enable access to care, united by one purpose: to pioneer breakthroughs in healthcare. For everyone. Everywhere. Sustainably. Check our Careers Site at https://www.siemens-healthineers.com/careers

As an equal opportunity employer, we welcome applications from individuals with disabilities.

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