Project Engineer

SeaSpine is uniquely transforming Spinal Surgery with safe, fast, real-time solutions that give surgeons and hospital partners the confidence to deliver better outcomes to improve patient lives-NOW. If you are interested in being a part of our amazing journey as part of the Engineering Team. We need to connect!

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.

Your key responsibilities

• 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.

Who you are

• 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).

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. 41 CFR 60-1.35(c)