Michael Mclean (Mba) Email & Phone Number

Hanover, Maryland , Us

Melbourne, Florida, Us

Melbourne, Florida, Us

Brea, California, Us

Marlborough, Ma, Us

Responsible for initiation and management of projects pertaining to manufacturing of existing products and new product introductions into production. Develops and executes project plans. Directs cross functional teams to meet project objectives. Communicates project status to all levels of division.• Development of project plans to related to manufacture of existing products and new product introductions into production. • Identify, plan and lead Value Improvement Projects (VIP), CAPA and new product manufacturing development projects. • Manage cross-functional teams; lead teams effectively; provide input to functional managers on team and team member performance.• Work cross functionally to establish, prioritize and ensure accountability to projects in improving department or plant performance.• Work with business partners to drive financial analyses of candidate projects. • Ensure compliance to quality systems and partner with Quality function in setting direction for projects. • Initiate cross functional partnerships to identify and resolve production/engineering issues. • Mentoring and training of the Manufacturing Engineering team in project management related topics and best practices. • Setting priorities, scheduling and assigning tasks. • Manages the technical challenges of technology application and new product development; identifies, communicates, and manages levels of technical risk.

Fridley, Minnesota, Us

• Organized/Lead multifunctional medical device project team consisted of R&D Engineers, Regulatory, Quality, Project Coordinator, Advance Manufacturing Engineer and Global Marketing Manager. Lead all tactical activities from VOC/Concept phase to product launch phase.• Developed comprehensive strategic project business plans and PDP contracts for multiple projects - including project internal and external spend, capitol spend and project plan. The PDP contract identified project goals, milestones and monthly key performance indicators. This contract is updated during various stages of the contract and tracked during monthly updates to the executive team.• Lead project team to launch 2 new single use product lines. These devices required project management to ensure product and packaging design, qualification of new OEM manufacturing supplier, validation of new sterilization supplier, design and validation of 9 different steel tools, transferred to two international manufacturing facilities and worldwide logistics established. The project came in on time and under budget.• Managing joint project, with Siemens Medical, to launch CAN Class 4 software platforms. This project included a joint effort to launch a product simultaneously with a large scanner. This project required internal and external project management skills. Project included updated software and operators manuals. • Responsible for all tactical product development activities - project design history files, developing customer requirements, product requirements, software requirements, FMEA, Risk Analysis, software development plan, and software verification.• Responsible for all sustaining engineering activities in two different international and one domestic plant. Support includes (32) high volume disposable product codes.• Perform all HR duties fro 8 direct employees including quarterly reviews, coaching, motivation and team building.

Deerfield, Illinois, Us

• Managed an engineering team tasked to design, build and validate an automated syringe medical device assembly line. Established a pilot assembly process, validated process and vision system then transferred to manufacturing for successful product qualification. This assembly line produces 120 syringes per minute that are capped, banded and packaged. The line collected all key characteristics of the assembly and captured each syringe using a vision inspection system.• Lead team to re-designed package to house 200 or 400 per box. This effort required packaging, sterility and stability testing and new 510K submitted.• Lead team to redesigned two major sub-assembly systems to address top field complaints on an automated syringe delivery system. Redesign reduced the cost by over 1,000 per device and solved the top 2 field complaints.• Managed all manufacturing engineers, technicians, and assemblers to build and install a pharmaceutical delivery system. Each device was custom manufactured for a specific hospital system.

Deerfield, Illinois, Us

• Created Central Engineering Department to supply project management, tooling, industrial and automated testing for new products within Baxter.• Organized Alyx aphaeresis system core team. Team consisted of (6) Mechanical/Electrical/Software Engineers, (1) Planner, (1) Quality Engineer, (1) Project Coordinator, (1) Purchasing Engineer, (1) Tooling Engineer, (1) Industrial Engineer and (2) Software Test Engineers. Team formed during VOC phase and ended when product launched. Project was on schedule and within budget for entire project.• Coached Project Manager to launch Triton Medication Delivery System. Team consisted of (4) Mechanical/Electrical/Software Engineers, (1) Software Test Engineers, (1) Quality, (1) Project Coordinator, and CAD technician. The first year of production was performed in USA then transferred to Singapore for long term production. All product transfer activities managed by project manager.• Project Manager to transfer manufacturing of Dialysis device from a purchased medical device company. Team consisted of (4) Manufacturing Engineers, (1) Software Test Engineers, (2) Supplier Quality Engineers, (1) Project Coordinator, and (2) CAD technician. Transfer required vendor consolidation, 50 tools transferred, BOM and manufacturing procedures and drawings.• Automated all test fixtures to allow for final assembly automation resulting in head count reduction of 15.• Lead team to incorporate an automated vision system used to verify all disposable products are assembled correctly, placed in the correct place and not visual defects in an automated assembly line in Puerto Rico.• Published article for Assembly Magazine and speaker at the assembly design show in Chicago.

Munich, De

• R&D Team Lead - Lead a small tactical engineering team through feasibility, concept, development and qualification phases for a fluidic subassembly used in a chemistry diagnostics device. The system consisted of 65 valves, 3 acrylic manifolds, heated reagent bath and reagent probes. The team designed manufactured prototypes, maintained documentation design control, and reliability responsibility. This project required part design, tool design, prototype build used for feasibility testing and final steel tool design. • Manufacturing Manager - Managed staff of 5 supervisors, 75 assemblers, technicians and engineers. Responsible for each department budget, day to day operation and reviews. We manufactured power chemistry reagents, in clean room environment, and assembled research spectrophotometers, chemistry analyzers, spectrophotometers and Ion specific analyzers.• Advanced Engineering Manager – Managed team of 10 Engineers and responsible for all sustaining engineering activities. Automated entire floor to paperless process supported engineering headcount cost through yearly cost reductions, mechanical supplier selection and support. Lead team to install new surface mount line and de-install through hole line used in manufacturing. Project responsibility included capitol selection, procurement, IQ/OQ/PQ qualification, training and BOM updates.• Service Project Engineering Manager – Responsible for the transfer of new products to the service group. This included service training, establishing service kits and served as core team member for new products.

Master Of Business Administration (Mba), Mba

Bs, Electrical Engineering Technology, Business

As, Biomedical Electronic Technology

Master Of Business Administration (Mba), Business Administration And Management, General