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Senior Advanced Manufacturing Engineer - Mechanical

Job Description

Position Title: Senior Advanced Manufacturing Engineer – Mechanical

 

Company Background

Corindus Vascular Robotics, Inc. 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. Corindus is advancing the field of interventional medicine with robotics through improvements to procedural control, precision and workflow.

Position Summary:

The Senior Mechanical Advanced Manufacturing Engineer will be part of the Product Engineering organization, responsible for the successful transition, integration and support of the next generation robotic platform that will change the future of healthcare. You will be a highly visible technical resource having diverse responsibilities and influence throughout the product lifecycle.  You will leverage technical leadership abilities, negotiation skills, and industry expertise to influence complex robotic medical device designs in order to implement efficient, value-add manufacturing tools, test equipment and workflows. You will have a strong working knowledge of ERP systems, mechanical engineering design principles and machine design with expertise in HALT/HASS testing, DFx, expert knowledge of tools and processes used to quantify risk, and leading NPI projects in regulated industries, preferably medical device.  Having outstanding analytical, organization, communication and presentation skills, you will convey complex information in clear, concise, and easily understood language.  This is a collaborative opportunity where you will work with and support several diverse engineering functions and teams.  Ideal candidate has an impressive portfolio of projects leading complex NPI programs, implementing efficient manufacturing processes and equipment, significant LEAN experience and who possess strong verbal and written communication skills.

Primary Responsibilities:

  • Collaborate with R&D to develop NPI project plans leveraging 6 Sigma, DFx, cGMP, and DMAIC through novel and effective processes and standardized work.
  • Support prototype and pilot production of new products, product changes, and enhancements in coordination with the R&D, Product Engineering, Manufacturing and Quality Control functions.
  • Develop protocols and perform IQ, OQ, PQs.
  • Provide training and technical leadership to operations resolving test, process, product, and quality-related issues.
  • Designs, builds, validates complex electro-mechanical assembly and tools used to manufacture and characterize subassembly and system-level performance.
  • Assist in vendor and supplier management, develop and maintain project schedules and budgets, capital equipment planning and justification, create BOMs/Routings and validation master plans.

Qualifications:

  • Bachelor’s degree in mechanical or Manufacturing Engineering required, Master’s preferred
  • 5+ years of experience in Manufacturing, Sustaining, Product Engineering or similar manufacturing design role in a regulated industry required, preferably in medical device.
  • Proficiency using statistical analysis tools such as: DOE, SPC, Capability Analysis, and reliability analysis required.
  • Experience in the design and manufacture of robotic systems highly desired
  • Deep understanding of DFM, DFA, and DFT required

·       Six Sigma, Black Belt Certification is a strong plus.

  • Strong communication, presentation and interpersonal skills are required
  • Proficiency with Microsoft suite of office tools (Word, Excel, PowerPoint, Visio, Project) required
  • Ability to travel up to 10% required
  • 80% on-site work is expected.
  • Advanced SolidWorks proficiency with demonstrated capability to produce complex parts and assemblies required
  • Electromechanical design experience, working with SolidWorks Electrical 2D and 3D highly desired
  • SolidWorks PDM experience required


Organization: Siemens Healthineers

Company: Corindus, Inc.

Experience Level: Mid-level Professional

Job Type: Full-time



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