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Mechanical Engineer / Project Engineer

Curis System Llc
  • OVIEDO, FL
  • Full-time
30+ days ago

Job Description

Benefits:
  • 401(k)
  • Competitive salary
  • Dental insurance
  • Health insurance
  • Paid time off
  • Vision insurance
  • Wellness resources

Position Summary


We are seeking a highly motivated Mechanical Engineer / Project Engineer with 5+ years of professional engineering experience and strong 3D CAD design expertise to support the development, implementation, and continuous improvement of advanced biodecontamination systems and equipment. The ideal candidate will possess a blend of mechanical design, product development, and project management skills, with experience in regulated industries such as pharmaceutical, biotechnology, healthcare, medical device, cleanroom, or contamination control environments.


This role is responsible for leading projects from concept through manufacturing and customer deployment while ensuring products meet performance, quality, regulatory, and customer requirements. The successful candidate will work closely with cross-functional teams to deliver innovative, reliable, and cost-effective biodecontamination solutions.  This position will require up to 25% travel.


Key Responsibilities


Mechanical Engineering & Product Development


  • Design and develop mechanical components, assemblies, and systems for biodecontamination equipment and related technologies.
  • Create and maintain detailed 3D models, assemblies, manufacturing drawings, and bills of materials (BOMs) using CAD software such as SolidWorks, Creo, or Autodesk Inventor.
  • Support the full product development lifecycle from concept generation through prototype development, testing, manufacturing, and product launch.
  • Perform engineering calculations, tolerance stack-up analyses, material selection, and design verification activities.
  • Develop and maintain engineering documentation including specifications, test protocols, validation reports, user manuals, and design records.
  • Conduct root cause investigations and implement corrective actions for product, manufacturing, and field issues.
  • Collaborate with manufacturing teams to improve product quality, reliability, manufacturability, and cost efficiency.
  • Participate in design reviews, risk assessments, FMEA activities, and engineering change management processes.
  • Ensure designs comply with applicable safety, quality, and regulatory requirements.
Project Management & Leadership


  • Lead engineering projects from concept through design, manufacturing, validation, and customer deployment.
  • Develop project schedules, budgets, resource plans, and technical deliverables.
  • Coordinate cross-functional teams including Engineering, Manufacturing, Quality, Supply Chain, Service, Sales, and Regulatory Affairs.
  • Track project progress and communicate status, milestones, risks, and mitigation plans to management and stakeholders.
  • Manage engineering change requests and ensure project objectives are achieved on schedule and within budget.
  • Lead customer technical discussions, project reviews, and design meetings.
  • Support installation, commissioning, and startup activities when required.
  • Drive continuous improvement initiatives utilizing project management best practices and lessons learned.
Required Qualifications


  • Bachelor's Degree in Mechanical Engineering or a related engineering discipline.
  • Minimum 5 years of mechanical engineering and product development experience.
  • Minimum 3 years of experience with and strong proficiency in 3D CAD software (SolidWorks preferred, Creo, Inventor, or equivalent).
  • Demonstrated experience managing engineering projects, timelines, budgets, and deliverables.
  • Strong knowledge of mechanical design principles, materials, manufacturing processes, and assembly methods.
  • Experience creating detailed manufacturing drawings and documentation.
  • Knowledge of GD&T, tolerance analysis, and engineering calculations.
  • Experience with engineering change management and product lifecycle management processes.
  • Strong analytical, problem-solving, and troubleshooting skills.
  • Excellent written, verbal, and presentation communication skills.
  • Proven ability to work independently and effectively within cross-functional teams.
Preferred Qualifications


  • Experience in the biodecontamination, pharmaceutical, biotechnology, medical device, life sciences, cleanroom, or contamination control industries.
  • Experience with Vaporized Hydrogen Peroxide (VHP), sterilization systems, isolation technology, environmental control systems, or decontamination equipment.
  • Familiarity with GMP, ISO, ASME, CE, and other applicable industry standards.
  • Experience designing electro-mechanical systems, sheet metal components, machined parts, and fabricated assemblies.
  • Knowledge of Design for Manufacturing (DFM) and Design for Assembly (DFA) methodologies.
  • Formal project management training or certification (PMP, CAPM, or equivalent) a plus.
  • Experience supporting customer-facing projects in regulated environments.
Technical Skills


  • 3D CAD Modeling and Design
  • Mechanical System Design
  • Product Development
  • GD&T and Tolerance Analysis
  • Engineering Drawings and Documentation
  • Root Cause Analysis
  • FMEA and Risk Assessments
  • Design for Manufacturing (DFM)
  • Design for Assembly (DFA)
  • BOM Management
  • Prototype Testing and Validation
  • Engineering Change Management
  • Project Planning and Scheduling
  • Budget and Resource Management
  • Risk Assessment and Mitigation
  • Cross-Functional Team Leadership
Desired Competencies


  • Excellent leadership and team collaboration abilities.
  • Ability to manage multiple concurrent projects in a fast-paced environment.
  • Results-oriented with a focus on quality, customer satisfaction, and continuous improvement.
  • Strong attention to detail while maintaining a strategic perspective.
  • Effective decision-making and problem-solving capabilities.
  • Ability to communicate technical concepts to both technical and non-technical audiences.
  • Self-motivated, proactive, and capable of driving projects to successful completion.
  • Strong project management and organizational skills. 

Numbers & Facts

LocationOVIEDO, FL
Job TypeFull-time

Skills

  • 3D Designunmatched
  • 3D Modelingunmatched
  • Analysis Skillsunmatched
  • Autodesk Inventorunmatched
  • Best Practicesunmatched
  • Bill of Materials (BOM)unmatched
  • Biologyunmatched
  • Biotech and Pharmaceuticalunmatched
  • Budget Managementunmatched
  • Budgetingunmatched
  • CAD (Computer-Aided Design) Softwareunmatched
  • CAD/CAM (Computer-Aided Design/Computer-Aided Manufacturing)unmatched
  • Calendar Managementunmatched
  • Change Order Managementunmatched
  • Cleanroomunmatched
  • Commissioningunmatched
  • Communication Skillsunmatched
  • Continuous Improvementunmatched
  • Control Systemsunmatched
  • Corrective Actionunmatched
  • Cross-Functionalunmatched
  • Customer Relationsunmatched
  • Customer Satisfactionunmatched
  • Customer Support/Serviceunmatched
  • Dental Insuranceunmatched
  • Design Verificationunmatched
  • Design for Assembly (DFA)unmatched
  • Detail Orientedunmatched
  • Documentationunmatched
  • Electromechanical Designunmatched
  • Electromechanical Systemsunmatched
  • Engineeringunmatched
  • Engineering Change Managementunmatched
  • Engineering Change Orderunmatched
  • Engineering Managementunmatched
  • Failure Mode and Effects Analysis (FMEA)unmatched
  • GMP (Good Manufacturing Practices)unmatched
  • Geometric Dimensioning and Tolerancingunmatched
  • Health Insuranceunmatched
  • Healthcareunmatched
  • ISO (International Organization for Standardization)unmatched
  • Identify Issuesunmatched
  • Industry Standardsunmatched
  • Leadershipunmatched
  • Manufacturingunmatched
  • Manufacturing Assemblyunmatched
  • Manufacturing Bill of Materials (mBOM)unmatched
  • Manufacturing Designunmatched
  • Manufacturing/Industrial Processesunmatched
  • Materials Analysisunmatched
  • Mechanical Assemblyunmatched
  • Mechanical Designunmatched
  • Mechanical Engineeringunmatched
  • Medical Equipmentunmatched
  • Multitaskingunmatched
  • Organizational Skillsunmatched
  • PTC Creounmatched
  • Presentation/Verbal Skillsunmatched
  • Problem Solving Skillsunmatched
  • Process Improvementunmatched
  • Product Developmentunmatched
  • Product Lifecycleunmatched
  • Product Lifecycle Managementunmatched
  • Product Supportunmatched
  • Product/Service Launchunmatched
  • Project Designunmatched
  • Project Engineeringunmatched
  • Project Management Certificationunmatched
  • Project Management Professional (PMP)unmatched
  • Project Planningunmatched
  • Project Scheduleunmatched
  • Project Trackingunmatched
  • Project/Program Managementunmatched
  • Prototypingunmatched
  • Quality Managementunmatched
  • Regulationsunmatched
  • Regulatory Requirementsunmatched
  • Resource Managementunmatched
  • Risk Analysisunmatched
  • Risk Managementunmatched
  • Root Cause Analysisunmatched
  • Safety Complianceunmatched
  • Salesunmatched
  • Schedule Developmentunmatched
  • SolidWorksunmatched
  • Startupunmatched
  • Sterilizationunmatched
  • Supply Chainunmatched
  • Team Lead/Managerunmatched
  • Team Playerunmatched
  • Technical Deliveryunmatched
  • Test Plan/Scheduleunmatched
  • Testingunmatched
  • Time Managementunmatched
  • Tolerance Analysisunmatched
  • Validation Planunmatched
  • Validation Testingunmatched
  • Vision Planunmatched
  • Willing to Travelunmatched
  • Writing Skillsunmatched

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