Engineer, Product Development Design

NEW PRODUCT DEVELOPMENT ENGINEER

POSITION SUMMARY:

The Engineer I performs assignments that require the application of standard engineering techniques and processes.  The assignments will have clear and specified objectives and require the investigation of a limited number of variables.  A moderate exercise of judgment is required on details of work and in making selections and adaptation of engineering alternatives.  The Engineer I will receive general direction on new aspects of assignments.  The work performed will involve conventional types of plans, investigations, structures, or equipment with relatively few complex features for which there are precedents. 

 This position is remote.  

ESSENTIAL DUTIES and RESPONSIBILITIES: 

• Participate on cross functional project teams through all phases of the product development process including planning and product launch.
• Work with project core team to assist in defining user needs, generate design concepts and prototypes, and perform design evaluations (such as tolerance analysis, FEA, DOE, simulated use testing etc).
• Assist in the creation of product process validation plans and testing.
• Assist other design engineers, manufacturing engineering and suppliers to optimize designs for manufacturability, prototypes and process engineering change requests.
• Assignments will usually include one or more of the following:
  • Test of materials
  • Preparation of specifications, which include engineering drawings
  • Research investigations
  • Report preparation, including protocols, engineering reports, and design control documentation
  • Other activities of limited scope requiring knowledge of principles and techniques commonly employed in specific narrow areas of assignments
  • May be assisted by a draftsperson or technician 

KNOWLEDGE and SKILLS:

Knowledge of:

• Medical device industry
• Project Management
• Three-Dimensional Parametric Solid Modeling
• FDA QSR and ISO 13485 quality standards
• Quality standards within the company
• Scheduling work to achieve goals
• Customer focused environment

Skills in:

• Strong organizational skills
• Strong verbal, written and presentation skills 
• Problem solving , mechanical design, and statistical evaluation
• Process development and improvement
• Computer skills, including 3-D CAD , Word, Excel, and PowerPoint
• Familiarity with project management concepts

Ability to:

• Self-Motivated
• Managing a variety of assignments concurrently
• Be flexible and adapt to changes in work environment, requirements, and assignments
• Interface professionally and courteously with customers/public/internal staff
• Prioritize work
• Meet goals and objectives set for department and company
• Keep current in changing work methods and regulatory changes

EDUCATION and EXPERIENCE:

• A minimum of a BA/BS in Engineering 
• Demonstrated understanding of various types of mechanisms, materials, proper tolerancing, drafting standards, design for mold ability and GD&T are required

• Experience utilizing computer aided design (CAD) to develop a product is strongly desired

WORK ENVIRONMENT:

• Well lighted, heated/or air-conditioned indoor office/production setting with adequate ventilation.
• Light physical activity performing non-strenuous daily activities of a primarily administrative nature.
• Ability to maneuver throughout the facility/facilities as needed.
• Manual dexterity sufficient to reach/handle items and work with fingers.
• Ability to wear proper PPE.

Equal opportunity employer as to all protected groups, including protected veterans and individuals with disabilities

Americans with Disabilities Americans with Disabilities Act (ADA): Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

The statements herein are intended to describe the general nature and level of work being performed by employees and are not to be construed as an exhaustive list of responsibilities, duties, and skills required of personnel so classified. Furthermore, they do not establish a contract for employment and are subject to change at the discretion of the Company.