Senior Mechanical Engineer

2 days ago

Montvale, New Jersey, United States PENTAX Medical Full time
Job Summary

The Senior Mechanical Engineer will be responsible for leading the design and development of mechanical devices for PENTAX Medical. This includes developing innovative design concepts, creating detailed designs, and overseeing engineering concept and feasibility tasks. The ideal candidate will have a strong background in mechanical engineering, experience in the medical device field, and proficiency in CAD software and 3D printing.

Key Responsibilities
  • Provide technical leadership on new and complex initiatives for the development and commercialization of energy-based devices at PENTAX Medical.
  • Create concepts, prototypes, and detailed designs of new energy-based diagnostic and therapeutic devices and/or for significant product changes to existing products.
  • Develop design inputs, including marketing requirements and design specifications, with associated justification for new product development.
  • Work with physicians and product management to define elegant technical solutions to clinical problems.
  • Lead risk analysis and risk management activities, including human factors studies, and create risk assessments, risk management plans, and risk management reports.
  • Participate in animal and clinical studies, travel as needed, and conduct research and publish as appropriate.
  • Approve designs, test protocols, and reports.
  • Responsible for adhering to design controls and documenting all product development work in a Design History File.
  • Justify new product development and develop project plans and budgets.
  • Conduct business development research and due diligence activities as directed by supervisor.
  • Create presentations to senior leadership for design project updates and milestones reached.
  • Comply with FDA/Other-markets Regulation and Guidance as required for PENTAX Medical Design Controls systems.
  • Other technical, design documentation, DHF documentation, and project management tasks as defined by supervisor.
  • Other duties as assigned by management.
Requirements
  • BS or MS in Mechanical Engineering.
  • (3+ with MS) or (5+ with BS) years of experience in mechanical design.
  • Experience in the medical device field strongly preferred.
  • Interventional catheter experience a plus.
  • Experience in cryo-ablation and designing with small amounts of cryogenic gases a plus.
  • Complete knowledge of Design Control & Quality Systems.
  • Proficiency in CAD software and 3D Printing.
  • Able to take product from concept through production release.
  • Ability to manage multiple projects and competing priorities.
  • Experience with various manufacturing methods such as injection molding, metal stamping, machining, etc.
  • Strong verbal and written communication skills.
  • Agile experience desirable.
  • Knowledge of ISO/FDA regulations preferred.
PENTAX Medical is an Equal Opportunity Employer

PENTAX Medical is committed to providing equal employment opportunities to all employees and applicants. We do not discriminate based on age, color, disability, gender identity, genetic information, military or veteran status, national origin, race, religion, sex, sexual orientation, or any other applicable status protected by state or local law.

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