GENERAL SUMMARY: The Development Engineer supports the Project Core Team over the course of a project, performing engineering tasks to bring products from conception to market release. Participates in product development and lifecycle maintenance including beginning to end activities on new and sustaining product development. Day to day activities range from collaborating with Project Core Team on design details and working with project customers (surgeons, marketing staff, and technical sales force). Position is a supportive, subordinate role.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Completing tasks assigned in a timely manner
• Supports Design History File and Risk Management File creation and maintenance
• Work directly with surgeons and surgical staff in an Operating Room environment to generate and validate user needs.
• Work with surgeons, sales and the Project Core Team to develop concept designs into usable products
• Solve surgical problems by applying engineering solutions through mechanical hardware
• Generate verification/validation protocols, carry out product evaluations per the protocol, and generate reports summarizing the testing
• Work with other Project Core Team members to provide information necessary for project tasks
• Communicate updates to Project Core Team and Management Team members regularly
• Understand/document project goals, work towards timeline goals
• Create 3-D CAD models and engineering drawings
• Develop an understanding of existing and new products
• Work within design controls (input, output, verification, validation)
• Creating and completing Functional Relationship Analysis (FRA) and the associated Protocols and Reports
• Work with suppliers to ensure products are cost effectively designed for manufacturability
• Perform product lifecycle management activities, including, but not limited to: investigating customer complaints, CAPAs, and executing design/documentation changes/updates.

SUPERVISORY RESPONSIBILITIES: There are no supervisory responsibilities.

QUALIFICATIONS: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. (The requirements listed below are representative of the knowledge, skill and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.)

• Must comprehend and understand how product is machined, cast, forged, or formed
• Work experience in regulated industry/medical devices is strongly desired
• Familiarity with CAD system-Unigraphics/NX preferred
• Familiarity with geometric tolerancing and dimensioning (GD&T)
• Must possess strong mechanical design skills
• Must be able to work on various projects as priorities change or directives are adjusted
• Problem solving skills required
• Ability to work within a team setting
• Ability to travel as needed

EDUCATION AND/OR EXPERIENCE: BS in mechanical or biomechanical engineering from an ABET accredited engineering school required. Familiarity with geometric tolerancing and dimensioning, experience with medical grade materials (metallic and non-metallic), and knowledge of standard machining and manufacturing processes preferred. 3-5 years of experience in mechanical design (orthopedic mechanical design preferred).

LANGUAGE SKILLS: Ability to read and comprehend instructions, correspondence, and memos. Ability to prepare routine reports and correspondence. Ability to communicate effectively with customers, vendors and other employees of the organization. Requires excellent grammar and spelling.

Mathematical Skills: Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals.

Reasoning Ability: Ability to apply common sense understanding to carry out instructions furnished in written, oral, or diagram form. Ability to deal with problems involving several concrete variables in standardized situations.

Certificates, Licenses, Registrations: Requires a valid driver’s license.

Other Skills and Abilities: Requires the ability to operate a variety of standard office equipment, such as a computer and keyboard, calculator, photocopier, telephone, cell phone, etc. Requires proficiency with Microsoft Word, Excel, Outlook and PowerPoint.

physical demands: (The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.)

While performing the duties of this job, the employee is regularly required to sit and use hands to finger, handle or feel. The employee is frequently required to climb stairs, talk and hear. The employee is occasionally required to stand; walk; reach with hands and arms; and stoop, kneel, crouch, or crawl. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, and ability to adjust focus.

Work Environment: (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.)

The noise level in the work environment is that found in a “normal office environment; noise levels during visits to other locations in the building may be moderate and occasionally loud. Occasional travel may be necessary.

The above statement reflects the general details necessary to describe the principal functions of the occupation described and shall not be construed as a detailed description of all the work requirements that may be inherent in the occupation.