Manufacturing Engineer jobs in United States
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Integrity Orthopaedics, Inc. · 18 hours 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.

Health CareMedicalTherapeutics
Hiring Manager
Bryan Maloney
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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

Manufacturing EngineeringProcess DevelopmentCADMedical Device ExperienceDFMContinuous ImprovementLeadershipCommunicationProject ManagementProblem Solving

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, Inc.

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Integrity Orthopaedics emerges as a pioneering force dedicated to redefining the landscape of soft tissue repair.

Funding

Current Stage
Growth Stage
Total Funding
$20.6M
Key Investors
Piper Jaffray Merchant Banking
2024-04-30Series B· $20.6M

Leadership Team

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Tom Westling
Founder, President & CEO
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Company data provided by crunchbase