Position Description: Mechanical designer with a creative mind, analytic and communication abilities, and a proven record in developing 3D models and working drawings. The successful candidate will be wise to the risks and course corrections of a small company, and thrive in an environment that adheres to the guidance of FDA regulations, while making breakthroughs in medical science.
Bachelor’s degree in Mechanical Engineering preferred.
Minimum of five years of mechanical engineering/design.
Extensive experience with 3D CAD software required. Experience with Autodesk Inventor preferred.
Experience in medical devices or FDA regulation is a plus.
Responsibilities and Requirements:
Build 3D CAD models, including the detailing of individual components, creation of exploded views, preparation production/manufacturing drawings, and generate production Bills of Materials.
Understand and have experience in establishing design specifications, manuals, and other data evaluating feasibilities, costs, and maintenance requirements of designs and their applications.
Understand, implement and follow design processes in keeping with FDA regulations.
Evaluate, research and recommend design alternatives and solutions.
Analyze design feasibility, operation and performance of equipment, components and systems to establish, validate and execute design specifications. Collaborate with production, software and electrical personnel in cross functional teams moving a product from concept through validation, manufacturability, launch and support.
Create, identify and communicate opportunities for intellectual property (IP) protection, e.g. patents, and work with management and legal personnel to identify and obtain desired IP protections.
Document and maintain relevant, required regulatory records.
Assist in developing risk assessments and evaluations for new and existing products.
Must be a self-starter, and able to work both independently and successfully collaborate in teams
Must be able to communicate with scientists, production personnel, engineers, software developers, and marketing and sales team members
Strong analytical and problem solving skills, demonstrated ability to multi-task
Must be able and willing to generate necessary design and regulatory documentation
All employees are required to function in a variety of roles, sometimes outside a given job function. Flexibility and adaptability are a necessary attribute for a successful NKI employee.
Neuro Kinetics, Inc. is an Equal Opportunity Employer. It is our policy to make all personnel decisions without discriminating on the basis of race, color, creed, religion, sex, physical disability, mental disability, age, marital status, sexual orientation, citizenship status, national or ethnic origin, and any other protected status.