Design Engineer

POSITION SUMMARY

The Design Engineer is responsible for assistance in the design and development of new products, sustaining existing products, including reviewing product designs, creating solid models, and detailing prints.  This person will work under minimal supervision and interface with internal departments both local and corporate, customers, vendors, and 3^rd party partners, all of which are essential to achieving the organization’s goal of on-time in-full production delivery and high quality products.

PRINCIPAL RESPONSIBILITES

• Executes various aspects of engineering process which may include, but is not limited to, engineering modeling, engineering drawings, and bill of material (BOM) creation
• Sustains current products and product lines by responding to internal and external requests and inquiries in a timely manner
• Participates in the engineering change notice (ECN) and contract review process for the product development engineering team to ensure timely release of engineering changes and customer orders.
• Utilizes SolidWorks (3D Modeling) to create and/or modify designs and drawings.
• Supports and reviews applicable engineering experiments and associated technical protocols/reports to ensure all design and customer requirements are achieved
• Supports execution of design control procedures for all products in compliance with all domestic and foreign regulations
• Supports the NPI process to meet or exceed the requirements of the customer including technical, quality, timeline, and cost requirements.
• Supports organization and site policies and procedures, goals and objectives, applicable regulations, and good manufacturing practices.
• Assists with the design of gages, fixtures, and tooling.
• Addresses customers’ issues and improves performance, appearance, and impact of product on the end-user.
• Provides support to manufacturing, marketing, and customer service; interfaces with customers and suppliers.

REQUIRED KNOWLEDGE, SKILLS, AND ABILITIES

• Strong interpersonal skills: Ability to relate to and work with diverse groups of people. Coordinates project activities and resolves individual conflicts and issues. Handles sensitive and confidential situations and materials.
• Ability to develop collaborative relationships with customers, vendors, and team members within the organization.
• Teamwork: Pursue trust for each team member. Seek and deliver honest feedback to all team members. Committed and accountable to achieving team goals.
• Demonstrated organizational skills with the ability to handle and prioritize multiple projects/tasks simultaneously in a timely manner in a fast-paced environment.
• Possess mechanical engineering, analytical and problem-solving skills
• Proficient in modern computer aided design (CAD) software, Solidworks preferred
• Good working knowledge of manufacturing methods, processes (i.e. machining methods)
• Knowledge of applicable regulatory requirements and concepts including ISO 13485, ISO 14971, MDR 2017/745, CAPA, NCR, supplier control, manufacturing control, design control
• Sound written and oral communication skills. Ability to provide written and/or oral communication to management and technical staff audiences.
• Excellence in Microsoft Word, Excel, and PowerPoint
• Ability to prioritize and work independently with a sense of urgency
• Strong understanding of medical devices preferred.
• Good working knowledge of GD&T.

EDUCATION AND EXPERIENCE

• Minimum Bachelor’s degree in Mechanical Engineering, Biomedical Engineering or the equivalent in a related field.
• Minimum of 1 year of experience in similar engineering position or the equivalent preferred
• Basic understanding of machining and secondary process experience (welding, polishing, electropolish, passivation, assembly)
• Experience utilizing computer aided design (CAD) to develop or update a product
• Experience in medical manufacturing industry preferred.

PHYSICAL DEMANDS

While performing the duties of this job the employee is frequently required to stand, sit, walk, talk, and hear. The employee is occasionally required to reach with hands and arms, stoop, kneel, or crouch.

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

MISCELLANEOUS:

The duties listed above are intended only as illustrations of the various types of work that may be performed.  The omission of specific statements of duties does not exclude them from the position if the work is similar, related, or a logical assignment to the position.

The job description does not constitute an employment agreement between the employer and the employee and is subject to change by the employer as the needs of the employer and requirements of the job change.