the knitty gritty

---

Our tight-knit team has over 30 years in Med Device...had pretty cushy jobs too.  So, why'd we leave?

It's simple: Our team wants more.  More productivity, more exposure, more opportunities to lead, more return on investment, more expedited timelines, more value-add...just more.  A large org just couldn't quite provide that at the pace we wanted.  But, coming in to support multiple organization's achieve their goals as effectively as possible does deliver that opportunity.

• Opto-mechanical and electro-mechanical complex subassemblies for X-ray Imaging Units

• Trauma, Reconstruction, Cardiovascular, Orthopedic, Dental Implants and Instruments

• DOE's, Feasibility and Prototyping, V&V Testing, Validation Labs, Drafting and Print Creation, GD&T, DFM/DFA, Device Failure Analysis, SolidWorks, SolidEdge

• DHF Creation & Ownership: Design Development Plan, Risk Management Plan, IOVV, Use Map, FMEA's, MFG Summaries, PMS, Transfer to Production, Final Design Release.

• Equipment & Process Validations, Fixture and Tooling Design, Process Development & Optimization, Transfer to Production, 5S & Lean Mfg, BOM's, Routing's, CML's, DFMEA's, Continuous Improvement 

• Primary Processes: Milling, Turning (Swiss & Conventional), Injection Molding, 3D Printing, Extrusion & Pultrusion, Wire EDM, CNC Grinding, Gun-Drilling, Bending, Welding, Assembly

• Secondary Processes: Heat Treat, Anodize (Al & Ti), Chrome-Coat, Tumbling, Polishing, Laser Etching, Cleaning & Passivation, Biological Upgrade, Non-Sterile & Sterile Packaging,  Cleanroom assembly

• QMS Knowledge, FDA:13485 & ISO:14971, Risk Management, CAPA, Non-Conformances, Complaints, Post-Market Surveillance, Internal and External Auditing

• Metrology, TMV's, GR&R, Capability Studies, AQLs,  Vision Systems and Hard Gaging

• Environmental Monitoring, Process Monitoring, Biocompatibility, Root-Cause Analysis, Control Plans,  SPPA & Supplier Quality, Dock-to-Stock Qualification

• Production Transfers (US & OUS), Supply Chain Strategy, Vendor Selection, Facilities Engineering, Demand Planning and Sourcing, COG's Analysis and Reduction, Manufacturing Quotes, CapEx & OpEx budgeting, Inventory Management, Dual-Warehouse Distribution

• Product Management Experience,  New Product Launch, Business Case Development, VOC, Market Analysis, Sales/Commercial Strategy Development, Sales/Revenue Analysis,  Account Targeting Strategy, Product Positioning

• Collateral Design (Brochures, Flyers, Surgical Techniques, Training Videos, System Layout Brochures), Sales Rep Support and Shadowing in OR, Sales Force Trainings, Demo-Kit Creation and Deployment.

• Cross-Functional & Cross-Departmental Team Management, Employee Development, Team Building, Strategy Planning, Mentoring, Culture Champions

• Portfolio and Project Management: Portfolio of cross-functional projects including Manufacturing, Operations, Regulatory, Quality and IT.  Short duration and multi-year/multi-million dollar projects.