Experienced Design Engineer
Resume:
Robert MacKinnon III
Carver, MA 02330
Experienced Mechanical Engineer with ISO 9001 and ISO 13485 experience from Concept & Feasibility to Production. Designing from customer concept, Medical Devices ranging from FDA Class I through Class III including: Orthopedics, Subcutaneous Ports, accessories for use with Endoscopic and Bronchoscopy procedures, Face Masks, Intubation Mouthguards, Hermetic Feedthroughs. Experience in designing static and dynamic assembly fixtures. Experience in establishing, DIRs, DHAs, DFMEAs, PFMEAs, UFMEAs, DVPs, MVPs, PFCs, SOPs, FAIs, V&Vs, Engineering Change Orders, all while maintaining Good Document practices.
Current Employment
Manager of Engineering R&D, Primo Medical Group, 09/2023 to Present Role and Responsibilities:
Leading and managing a multidisciplined Engineering team, while collaborating with other departments to achieve department goals. Teaching and developing engineers in designing for manufacture, while building a team culture. Meet with potential customers and prepare Non-recurring Engineering proposals. Maintain and strengthen existing customer relationships with proposals for additional product lines.
Specific Job Traits:
• Evaluate and approve development product designed and assembly fixtures.
• Define development inputs and risks
• Assist engineering team with identifying and developing applicable testing or engineering studies.
• Prioritize work loads for engineering team to meet scheduling requirements. Design Engineer, Primo Medical Group, 11/2019 to 09/2023 Role and Responsibilities:
Research, Prepare, Evaluate, Analyze, and Finalize devices used in the medical field. Develop devices using Solidworks, incorporate surgeon and customer and manufacturing inputs to build live prototypes. Provide consultation for Sustaining and Manufacturing Engineers with feedback, design fixturing, testing approaches, improvements of existing fixtures used in the assembly and manufacture of production level devices, troubleshooting product failures and root cause analysis, troubleshoot process failures. Update and create Labels for product packaging. Provide feedback and mentor designers, delegate design tasks as required. Organize/ Delegate workflows for team members in the design group or project group to maintain an effective and efficient work environment. Specific Job Traits:
• CAD, Solidworks/ PDM: Parts, Assemblies, Drawings, configurations. Full understanding of Machining: 3D Printing, Molding, CNC, Swiss CNC, Swiss CNC Laser, Manual operation (Lathe and Mill), and welding; all used to incorporate into product creation.
• Meeting with customers to update status/ timeline of project, give feedback, suggestions, guidance including: Cadaver Lab Studies with customer and surgeon to better incorporate design feedback and ensure product function.
2 P a g e
• Source and vet components and material availability for project: (Examples) Collaborate with Mold Suppliers for product DFM, Product timelines. RFQ essential and ancillary components including: OTS/Custom pouches, blister trays, Tyvek Lids, Protective covers, Tamperproof seals.
• Work under demanding time tables and creating prototypes for Cadaver Labs, Benchmark Testing or other product testing/ Feedback.
• Work with other departments to maintain fixtures, ensure assembly-operator ergonomics, address questions or concerns with product design and functionality, establish Tooling Methods, DIR, PFMEA, DFMEA, Verifications, Validations, Engineering Studies.
• Create and maintain Customer Labels for pouching, shelf boxes, Master Shippers. Create barcodes, HIBC and GS1 specific for customer needs.
• Source and or design Pouches, Blister backs, shelf boxes, shipper boxes.
• Design validation testing for product testing (Torque, Tensile, Compression, Septum Retention and Penetration, Air Leak, Power Injection, Burst Testing, Cell Viability, Weld strength)
• Troubleshoot/ Debug current product failures, establish root cause and solution.
• Troubleshoot/ Debug current fixture failures, establish root cause and solution.
• Process Change orders, maintain Good Document Practices, identify inventory or Job Traveler conflicts.
Notable Achievements:
Designed from a customer concept to Partial Design Freeze of an entirely new set of 17 devices to perform an ‘open’ Orthopedic procedure to an arthroscopic one, in 7 months. Devices include: Cannulas, Dams, Seals, Obturators, Arthroscopic Measurement Device, Arthroscopic Cutters, Graft Delivery Devices, Graft Cutters, Debridement Tools, and all ancillary packaging and pouching items. [Patents Pending] Relevant Previous Employment:
Solidworks Modeler, Morgan Advanced Materials, 06/2016 to 11/2019 Role and Responsibilities:
Under the supervision of the Engineering Manager, create CAD models and drawings of customer prototypes. DFM prototypes and drawings, maintain CO records for facility, maintain excellent communication with Project managers and Manufacturing Engineers. Specific Job Traits:
• CAD, Solidworks: Parts, Assemblies, Drawings, configurations. Full understanding of Machining: 3D Printing, Ceramic Press, CNC, Manual operation (Lathe and Mill), Lapping, Sputtering, and brazing; all used to incorporate into product creation.
• Control ECO (Engineering Change Orders) for the facility. Update redlines and identify current job travelers and inventory conflicts.
• Work with Global Research and Development Manager to create new prototype ceramics.
• Instituted 3D Printing in the facility for us with Fixturing Notable Achievements:
Working with the Research and Development Manager, designed a method of constructing Ceramic Hermetic Feedthroughs without brazing. Patents [62/648,171] Education:
2016, Bristol Community College, Mechanical Engineering 2012-2015, University of Massachusetts at Dartmouth, Mechanical Engineering 2010-2012, Bridgewater State University, Mathematics
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