Engineering Manager

Orthofix•Carlsbad, CA

20d

About The Position

Why Orthofix? Guided by our organizational values – Take Ownership | Innovate Boldly | Win Together – we collaborate closely with world-class surgeons and other partners to improve people’s quality of life. At Orthofix, we want team members who build relationships and share knowledge, challenge the status quo, and deliver results every day to help us achieve our vision to be the unrivaled partner in Med Tech. Our global team of over 1,600 employees brings to market highly innovative, cost-effective, and user-friendly medical technologies that heal musculoskeletal pathologies for patients and the healthcare professionals who treat them. Looking to change people’s lives? Look no further. How you'll make a difference? The Manager, Engineering will facilitate team development, budget, planning, and process improvement activities on an ongoing basis. They are responsible for overseeing multiple high-level project team activities to develop concurrent and highly technical medical device systems from concept through market introduction and field support in accordance with FDA and ISO requirements. The Engineering Manager will draw upon established expertise to help their team achieve solutions to a variety of complex technical problems.

Requirements

Bachelor’s Degree in Engineering
5+ years’ experience in medical devices (Spine/Orthopedic device preferred)
Demonstrated ability leading teams and completing several projects on time and on budget with minimal supervision
Expertise in FDA QSR and ISO 13485 principles, including Design Controls and Risk Management
CAD experience required (Pro-Engineer/Creo, SolidWorks, or equiv.)
Strong computer skills are required including proficient and accurate usage of CAD software (Pro-Engineer/Creo preferred), word processing (Word), spreadsheets (Excel), charting, flow charting, and graphs
Ability to utilize a computer, telephone, fax, scanner, and copy machine as well as other general office equipment

Nice To Haves

Bachelor’s Degree in Engineering (Biomedical or Mechanical)
9+ years’ experience in medical devices (Spine or Orthopedic device)

Responsibilities

Oversees individuals leading design projects to develop and commercialize complex medical implant and instrument systems.
Establishes project plans, develop product requirements, and coordinate other team activities in accordance with Design Control and Risk Management procedures
Effectively interacts with interdepartmental personnel and external partners to uphold project plans and achieve project objectives
Supports strategic plans for process and plant improvements to increase efficiency and manage costs
Generates complex implant and instrument CAD models and detailed engineering drawings using CAD software to develop new device designs and/or maintain existing products
Supervises spinal implant and instrument designs throughout the manufacturing process
Participates in spinal implant and instrument system and process transfer to Manufacturing and Operations and on-going support after commercialization
Supports the evaluation and onboarding of new manufacturing partners
Effectively interacts with cross-functional teams within Marketing, Purchasing, Quality, Manufacturing, and Operations
Drives and supports process optimization, process and equipment troubleshooting, and process validation improvement initiatives
Supports investigations relating to spinal implant and instrument issues, product release performance, and/or customer issues
Identifies spinal implant and instrument projects to improve yield, lower costs and improve efficiency
Partners with Quality and Regulatory Affairs colleagues to ensure compliance with regulatory authority guidance for operations
Creates standard operations procedures, standard test procedures, and other related records
Maintains a safety-first approach to process development and manufacturing
Engages with surgeons, Sales team partners, and other field associates to support product development, marketing, and training activities
Works generally independently and some elements may be shared with senior engineering management
Attends, participates in, and leads departmental meetings as scheduled
Performs other duties as assigned