Project Engineer - Cervical Spine

The Project Engineer manages development of medical device systems from concept through market introduction in accordance with FDA and ISO requirements. Responsibilities include both technical design and project team coordination to address to a variety of complex technical problems. Work requires some supervision and draws upon significant experience and developing leadership abilities.

How you'll make a difference:

• Lead design projects to develop and commercialize medical implant & instrument systems. Coordinate cross-functional teams to complete project plans, product requirements, design & process specifications, verification & validation, and other DHF deliverables in accordance with Design Controls and Risk Management procedures.
• Generate 3D models and detailed engineering drawings using Creo CAD software to develop new device designs and/or sustain existing systems.
• Perform testing and analysis to ensure that designs satisfy functional and performance requirements. Draft protocols, reports, technical memos, and other documentation in accordance with Quality procedures.
• Engage with surgeons, Sales team partners, and other field associates to support product development, marketing, and training activities.
• Interface with vendors to address technical questions and supervise designs throughout the manufacturing process.
• Perform other duties as assigned.

Your key responsibilities:

• Bachelor's Degree in Engineering (Biomedical or Mechanical preferred)
• Experience in spine/orthopedic preferred
• 5+ years in related medical device engineering role
• Key contributor to multiple development projects. Ability to develop/co-develop detailed project schedules and manage execution by cross-functional teams with general guidance or assistance
• Established technical abilities for basic to complex device design, modeling and detailed engineering drawing generation using CAD software (Creo, SolidWorks, or equiv.)
• General understanding of Design Controls and Risk Management principles per FDA and ISO requirements with significant contributions made to DHF documentation
• Basic understanding of clinical applications and how to leverage knowledge to create high performing designs
• Ability to work effectively with inter-departmental personnel and external partners to achieve project objectives
• Ability to utilize a computer, telephone, fax and copy machine as well as other general office equipment
• Strong computer skills are required including proficient and accurate usage of CAD software (Creo preferred), word processing (Word), spreadsheets (Excel), presentations (PowerPoint), flow charting, and graphs).

The anticipated salary for this position is$101,012 to$115,000 per year, plus bonus, equity, and benefits. The final pay offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and years of experience within the job, the type and years of experience within the industry, education, etc.

We are committed to providing equal employment opportunities to all employees and applicants without regard to race (including traits historically associated with race, such as hair texture and protective hairstyles, including braids, locks, and twists), ethnicity, religion, color, sex (including childbirth, breast feeding, and related medical conditions), gender, gender identity or expression, sexual orientation, national origin, ancestry, citizenship status, uniform service member and veteran status, marital status, pregnancy, age, protected medical condition, genetic information, disability, or any other protected status in accordance with all applicable federal, state, and local laws.

This policy extends to all aspects of our employment practices including, but not limited to, recruiting, hiring, discipline, termination, promotions, transfers, compensation, benefits, training, leaves of absence, and other terms and conditions of employment.