Engineer - Product Development/Design

Job Title: Product Development / Design Engineer

ID#: J-xxxx

Department: Engineering and Operations

Job Description:

1. Purpose and Scope

The Product Development / Design Engineer is responsible for engineering and designing medical and nonmedical products. This person will work closely with the Engineering Manager. This position includes interfacing with clients including; project status meetings product development project planning tracking and reporting. Working with other internal technical teams is a key responsibility including clinicians industrial designers consultants vendors quality engineers and other support personnel as needed. The Product Development / Design Engineer should have experience in the development of products for the medical device / healthcare industry/ consumer products. This person should have knowledge of creative concept development clinical issues prototype experience and analytical ability.

1. Responsibilities

Responsibilities include:

• Create experiment with and evaluate new product concepts
• Participate in project brainstorming meetings
• Capable of designing initial prototypes of specific concepts
• Capable of developing and executing clinical and engineering testing protocols
• Capable of troubleshooting and debugging prototypes
• Perform engineering activities including ensuring customer requirements are met maintaining compliance with quality system requirements and participating in project status meetings
• Interface with clients regarding project status
• Assure project proceeds in accordance with the Synectic Design Control system.
• Perform according to detailed project timeline (start up to project completion).
• Participate in material component and device assessment and selection for devices and implants
• Develop and communicate to customers results using Microsoft powerpoint or word as applicable

1. Organization Relationships

The Product Development / Design Engineer reports directly to the Engineering Manager of the company. The Senior Product Development / Senior Design Engineer works closely with internal and external technical teams such as other engineers industrial designers clinicians and vendors.

Job Requirements:

1. Education and Training

• A minimum of a four year college degree in engineering or science or equivalent experience is required. Strong listening verbal and written communication skills required both with technical and non-technical people
• Minimum of five or more years of demonstrated success in product design and development engineering roles specifically including the following experience and qualifications:

• Success in advancement of multiple new product development projects from project startup through commercialization
• Demonstrated aptitude for creative out of the box thinking and translating customer needs into product ideas
• Strong mechanical and problem solving abilities
• Demonstrated ability to function independently and effectively within a multi-disciplinary team

1. Technical Requirements

• Knowledge of product development and manufacturing
• Skilled at thinking strategically innovating and applying technical knowledge to complex problems
• Proficient with recent versions of 3D CAD applications (SolidWorks preferred)
• Working knowledge of in-house machine shop capabilities and safety procedures.
• Knowledge of rapid prototyping techniques molding and extrusion methods metal processes and components and common medical device assembly processes
• Familiarity with operation of typical mechanical laboratory equipment as necessary for material component and device performance evaluation
• Solid data analysis data management basic statistics and experimental design skills
• Experience with design fabrication and validation of simulated use and standardized product performance tests
• Knowledge of polymer and elastomer properties and common fabrication methods and limitations
• Very proficient with PC-based office tools such as Microsoft Word Excel Outlook Powerpoint and Project
• Basic knowledge of classic stress analysis Finite Element Analysis and mold flow analysis
• Capable of conducting patent and competitive product research on the internet.
• Experience and working knowledge of quality systems

Required Experience:

Manager