Orthofix · 14 hours ago
Engineering Manager
Carlsbad, CA
Full-time
Onsite
Mid, Senior Level
$150K/yr - $181K/yr
5+ years expOrthofix is a company dedicated to improving people's quality of life through innovative medical technologies. The Engineering Manager will oversee multiple project teams to develop and commercialize complex medical implant systems while ensuring compliance with FDA and ISO requirements.
BiotechnologyHealthcareHealth CareMedical
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
Qualification
Required
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
Preferred
Bachelor's Degree in Engineering (Biomedical or Mechanical)
9+ years' experience in medical devices (Spine or Orthopedic device)
Benefits
Plus bonus
And benefits
Company
Orthofix
Orthofix is a global medical device company.
1001-5000 employees
H1B Sponsorship
Orthofix has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (4)
2024 (1)
2023 (2)
2022 (5)
2020 (2)
Funding
Current Stage
Public CompanyTotal Funding
$160M2024-11-07Post Ipo Debt· $160M
1992-05-01IPO
Leadership Team
Andres Cedron
Chief Legal Officer
Clay Aiena
Chief Information Officer
Recent News
2026-01-21
2025-12-24
MarketScreener
2025-11-04
Company data provided by crunchbase