Integrity Orthopaedics · 1 day ago
Manufacturing Engineer
Integrity Orthopaedics is a fast-growing medical device company transforming soft tissue repair with an innovative surgical device. As a Manufacturing Engineer, you will own the development, validation, and scale-up of manufacturing processes, directly contributing to product quality and efficiency.
Responsibilities
Lead development and optimization of manufacturing processes for soft-tissue repair device systems
Drive design for manufacturability (DFM) and transfer of robust processes into high-volume production
Develop and validate equipment, fixtures, and tooling for assembly and inspection
Partner cross-functionally with R&D, Quality, and Supply Chain to resolve technical issues and improve output
Execute structured root-cause analysis and corrective actions for production challenges
Support process validations, change controls, and documentation in compliance with ISO 13485/FDA QSR
Mentor junior engineers (Senior level) and contribute to process-improvement strategy
Lead cross-functional technical initiatives and major scale-up projects
Drive continuous improvement projects that significantly impact throughput and cost
Influence design decisions for manufacturability and production reliability
Act as a technical authority on manufacturing processes and equipment
Mentor and guide Engineer II/III level contributors
Qualification
Required
BS in Engineering (Mechanical/Manufacturing/Industrial or related)
2+ years engineering experience in manufacturing or process engineering
Familiarity with regulated medical device environments
Strong CAD and problem-solving skills
5+ years in manufacturing or process engineering, preferably in med device or regulated manufacturing
Proven track record of owning complex process validations and scale-ups
Strong leadership, communication, and project management skills
Preferred
Medical device manufacturing experience
Knowledge of DFMEA/PFMEA and quality system requirements (ISO 13485, FDA QSR)
CAD (SolidWorks preferred), SPC/DOE experience
Exposure to cleanroom or aseptic manufacturing environments
Benefits
Competitive compensation and benefits
Company
Integrity Orthopaedics
Integrity Orthopaedics aims to revolutionize soft tissue repair by enhancing initial strength and fostering an optimal healing environment.
Funding
Current Stage
Growth StageTotal Funding
$20.6MKey Investors
Piper Jaffray Merchant Banking
2024-04-30Series B· $20.6M
Recent News
2025-05-04
2025-05-04
2025-05-04
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