Senior Project Engineer

Orthofix•Carlsbad, CA

1d•$136,221 - $159,874

About The Position

Summary statement on overall purpose and function of the position. Lead one or multiple projects within product development delivering innovative solutions to clinical problems. Collaborate with internal cross-functional groups and external surgeon consultants to successfully design and commercialize novel spinal implants and instrumentation systems. Conform to company quality and compliance policies while maintaining a high standard of work.

Requirements

6-10 years of experience
Expert in modeling and drafting in CAD; CREO experience is mandatory, with exceptions requiring greater years of experience exemplifying the above duties and responsibilities of this role.
Experienced in principles and application of linear FEA.
Thorough understanding and ability to apply principles of GD&T.
Practical experience driving inspection and manufacturing requirements through print specifications.
Prior design experience utilizing medical materials, i.e. titanium alloys, stainless steels, etc.
General knowledge of machining practices as it relates to design for manufacturability.
Exceptional project management, time management, and soft skills required to effectively manage oneself and others.
Familiarity with quality systems in a regulated industry.
BSME or equivalent

Nice To Haves

Experience designing spine hardware
Basic understanding of biomechanics and human anatomy
Ability to work with legal counsel to assure protection and maintenance of intellectual property

Responsibilities

Design and commercialize medical device implant and instrument systems for spinal surgery.
Coordinate cross-functional teams to complete project plans, product requirements, design and development specifications, verification and validation activities, and other DHF deliverables in accordance with FDA Design Controls and risk management procedures.
Drive surgeon engagement and effective collaboration in order to generate product requirements and user inputs.
Lead labs, calls, and most interactions with surgeon partners, both in cadaveric settings and field operating rooms.
Create 3D models and detailed engineering drawings using CREO CAD software to develop new device design specifications and/or sustain existing systems.
Prepare and execute testing and analyses to ensure that designs satisfy functional and performance requirements.
Draft protocols, reports, technical memos, and other documentation in accordance with Quality procedures.
Disseminate knowledge and program status clearly and effectively, translating complex issues to a variety of audiences (both engineering and non-engineering) on a regular basis.
Must be comfortable and capable speaking in front of large groups, including the executive leadership team.
Develop, manage, and maintain detailed project schedules and budgets.
Interface with vendors to address technical questions and supervise designs throughout the manufacturing process.
Engage with sales team partners and other field associates to support product development, marketing, and training activities.
May manage or provide oversight to other team members and is expected to provide significant mentorship to junior engineers.
Will be expected to be a "go-to" resource amongst peers, setting standards both technically and culturally.
Must be capable of operating independently with little to no oversight.
Perform other related duties as assigned.