Development Engineer

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. They participate in product development and lifecycle maintenance, including activities on new and sustaining product development. Day-to-day activities involve collaborating with the Project Core Team on design details and working with project customers (surgeons, marketing staff, and technical sales force).

Essential Duties and Responsibilities

• Completing tasks assigned in a timely manner
• Supports Design History File and Risk Management File creation and maintenance
• Works directly with surgeons and surgical staff in an Operating Room environment to generate and validate user needs
• Works with surgeons, sales, and the Project Core Team to develop concept designs into usable products
• Solves surgical problems by applying engineering solutions through mechanical hardware
• Generates verification/validation protocols, carries out product evaluations per the protocol, and generates reports summarizing the testing
• Works with other Project Core Team members to provide information necessary for project tasks
• Communicates updates to Project Core Team and Management Team members regularly
• Understands/document project goals, works towards timeline goals
• Creates 3-D CAD models and engineering drawings
• Develops an understanding of existing and new products
• Works within design controls (input, output, verification, validation)
• Creates and completes Functional Relationship Analysis (FRA) and the associated Protocols and Reports
• Works with suppliers to ensure products are cost-effectively designed for manufacturability
• Performs product lifecycle management activities, including investigating customer complaints, CAPAs, and executing design/documentation changes/updates.

Supervisory Responsibilities

There are no supervisory responsibilities.

Qualifications

• 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
• Candidates with medical device industry experience are strongly preferred, especially those with expertise in spinal fusion implants and related instrumentation
• Knowledge of the clinical, regulatory, and technical requirements associated with spine fusion products is highly desirable

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.
• Proficiency with Microsoft Word, Excel, Outlook, and PowerPoint

Physical Demands

• Sit and use hands to finger, handle or feel
• Frequent standing, walking, reaching with hands and arms, stooping, kneeling, crouching, or crawling
• Lift and/or move up to 25 pounds occasionally

Work Environment

• Normal office environment
• Moderate and occasionally loud noise levels during visits to other locations in the building
• Occasional travel may be necessary