Design Engineer

Posted 5 years ago

The MiRus team led by Jay S. Yadav, MD, an internationally recognized interventional cardiologist and founder of a number of successful companies has pioneered new treatments for stroke and heart failure patients. Inspired by the pioneering material science of NASA for rocket engines, MiRus has created Rhenium based medical alloys that are transforming medicine by making surgeries less invasive and implants safer and more durable.

The team behind MiRus has a history of creating cutting edge technology and leverages its expertise in creating innovative technology for spine, orthopaedics, and structural heart disease. We are creating innovative medical device and procedural solutions for the treatment of spine, orthopaedic and structural heart disease for patients suffering from debilitating diseases. To accomplish this goal, we collaborate with the world’s best surgeons and doctors, hire gifted people and provide them with ample resources to solve complex problems.

We provide a safe, inclusive and merit-based workplace and expect our personnel to adhere to the highest ethical standards.

The Product Development Engineer I, is responsible for the support, implementation, execution, control and completion of specific project activities ensuring consistency with company strategy, commitments, and goals. This team member is a part of MiRus' R&D Team which focusses on design and development engineering of medical devices using a streamlined, proven process for taking a product from initial concept to production and regulatory approval.

This team member reports to the management of engineering and collaborates with other MiRus staff such as Product Development Engineers, Marketing and Manufacturing Staff, as well as with Customers.

• Provide Engineering support for projects as required including:
• Create and refine CAD models
• Create detailed engineering prints including tolerances (GD&T)
• Engineering Analysis including calculations, FEA, tolerance studies, FMEA
• Conceptualization, design and development of new products such as implants and instrumentation
• Performing competitive product reviews and analyses
• Performing intellectual property reviews and analyses
• Developing preclinical testing plans and protocols for feasibility and design V&V activities
• Creating design inputs from customer requirements
• Create and execute project work plans and revise as appropriate to meet changing needs and requirements
• Support internal and external activities required to carry out projects
• Administer the document (electronic and paper) control aspects of Mirus R&D, including Engineering project files, Design History Files, and Device Master Records
• Must comply with applicable ISO and FDA regulations as stated in Quality Management System (QMS).
• Other duties as assigned

• BS in Mechanical Engineering or Bio-engineering or equivalent required.

• 1 year of Product Development experience preferred.
• Experience to be in product design, preferably in medical devices and orthopaedics within an ISO
  13485 compliant design control system
• FDA and ISO systems for medical devices experience preferred

• Ability to use the computer and/or CAD (Solid Works preferred)
• Utilizing either written or oral format, ability to effectively communicate critical design/project information to other team members, management & customers
• Ability to prioritize and manage multiple tasks
• Ability to conduct research on project-related issues and products
• Must be able to learn, understand and apply new technologies
• Knowledge of and ability to apply organizational skills as well as good time management
• Ability to apply logic and reasoning to help solve complex problems in creative and effective ways
• Work well under direction, with limited supervision and make high-quality and communicate challenges faced clearly

Language

Skills:

Ability to read, analyse and interpret common scientific and technical journals and legal documents. Ability to present to team and management.

Mathematical

Skills:

Ability to apply advanced mathematical concepts such as exponents, logarithms, quadratic equations, and permutations. Ability to apply mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory and factor analysis.

The…