Staff Mechanical Engineer, R&D

Stryker•Waltham, MA
•Onsite

About The Position

Join Stryker’s Amplitude Vascular Systems (AVS) team in Waltham, Massachusetts as a Staff Mechanical Engineer, R&D. This engineering role supports advanced medical-device development, focusing on researching new concepts, building prototypes, and developing test methods to evaluate technical feasibility. The role contributes across the product development process, applying mechanical and electromechanical engineering expertise to explore concepts, solve complex design challenges, and evaluate innovative technologies. The engineer researches, designs, develops, modifies, and verifies medical-device components, modules, and subsystems. The role translates user and clinical needs into design inputs, specifications, and system-level designs; develops prototypes and testing methodologies; and designs and optimizes assemblies using design-for-manufacturability principles, materials knowledge, and manufacturing processes. It also involves creating and evaluating engineering drawings and models, applying medical-device standards and regulations, managing design risks and controls, and preparing engineering and Design History File documentation under the Quality Management System. The position partners with R&D, Quality, Manufacturing, Regulatory, Clinical, Marketing, and Project Management, communicating technical plans and supporting projects through design, development, and launch. The role is onsite in Waltham, Massachusetts, with 10% travel.

Requirements

  • Bachelor of Science degree in Engineering, Mechanical Engineering, Biomedical Engineering, or a related engineering discipline.
  • Minimum 4 years of engineering experience, preferably with research, prototyping, testing, feasibility, or product development.

Nice To Haves

  • Experience developing and optimizing mechanical or electromechanical assemblies using design-for-manufacturability principles.
  • Experience creating engineering drawings and models and applying geometric dimensioning and tolerancing.
  • Experience using computer-aided engineering tools.
  • Experience applying materials and manufacturing-process knowledge to product design.

Responsibilities

  • Research, design, develop, modify, and verify components, modules, and subsystems for medical devices.
  • Translate user and clinical needs into design inputs, specifications, and system-level designs.
  • Develop prototypes and testing methodologies to evaluate concept feasibility and address complex product design issues.
  • Design and optimize mechanical and electromechanical assemblies using design-for-manufacturability principles, materials knowledge, and manufacturing processes.
  • Create and evaluate engineering drawings and models using geometric dimensioning and tolerancing and computer-aided engineering tools.
  • Apply applicable medical-device standards and regulations to design requirements, verification strategies, design controls, and risk-management activities.
  • Create and refine engineering documentation, including Design History File documentation, in accordance with the Quality Management System.
  • Partner with R&D, Quality, Manufacturing, Regulatory, Clinical, Marketing, and Project Management; communicate technical plans and support projects through design, development, and launch.
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