John Luscinski

** ***** **. *********, ** ***** 781-***-**** Cell phone 617-***-****

Seeking a Fulltime Position Email: adfb1d@r.postjobfree.com

SUMMARY

Senior Mechanical Design Engineer with extensive design experience in product development in mechanical/electrical design across multiple industries both in full-time and contract positions.

Skill Sets:

Electro/Mechanical Machine Package Design, Motion Controlled Apparatuses, Semiconductor experience, Air Cooling breathing equipment, Capital Equipment Design for Semiconductor and X-ray, Instrument Systems Design E/M, Process Fixture design, Optical Fixture Design, Optical Calibration Equipment Design, Castings, Sheet metal and stamping design, Plastic Part design, mold design and validation for disposables/consumables, H/LV, Fluidic dispensing, Diabetic/drug injection devices, Human Factors Design, Tool Design, Heat Sealer Design, Reference plates, trouble diagnostics, Minitab for FAI statistical analysis, R&R Gage and tolerance stack.

SolidWorks/PDM, 2018, Creo, AutoCAD 2000, Drafting Certificate, Electrical Schematic interpretation, ECAD, Windchill PDM, Vault PDM, JIRA, SMARTEAM, DHF, FEA, CFD Flowtherm, COSMOS, MOLDFLOW, Surface design.

High applicable knowledge and application of GD&T, ANSI Y14.5, TOL STACK, UL,EUL, IEC 60601-1, ISO13485, FDA CFR 21, ISO 6,7,8, GMP, 510k submittal process, SAP Supply Chain management, Project implementation and management, IQ,OQ, PQ, Validation and Verification plans.

Organized, Prioritize, Analytical, Creative thinking, Effective listening, Accuracy, Attention to detail, Problem Solver, Goal oriented.

PROFESSIONAL EXPERIENCE

Senior Mechanical Hardware and Remediation Designer, Seimans Healthineers Inc Norwood MA August 2019 May 2020 Contract with Infortree Serv.

Product development of early stage and late stage design of optical blood gas analyzers. Redesign of current device for electromechanical issues for phase development to FAT for manufacturing.

Remediation and design transfer for the review of all documents and all necessary records to ensure that all CAD/Drawings documentation is complete and well supported by required verification and validation records. Worked within teams to properly identify procedural changes via redlines or a deviation process. Categorize components based upon a risk-based assessment into purchasing categories. Reviewed vendor selection criteria and component inspection requirements and make appropriate changes.

Define current issues with current designed device and make improvements to them. Collaborated with manufacturing on current issues and incorporate new manufacturing assembly procedures.

Prototype design using 3D printers and machine shops for both product design and fixture development.

Design of test fixtures to evaluate current products for validation and verification of assemblies. This included evaluation of aid units for bench top units including software integration for electromechanical integration. Collaborated with software development to make changes to running electromechanical programs.

Review of CAD models and current documentation, make changes and improvements to CAD models and drawings. Redline current discrepancies for current CAD models and drawings and send to local and offshore manufactures.

Defined quality issues with products from documentation to provide clear and concise manufacturing capabilities with current products for DFMA.

Collaborated with outside vendors to receive new designed products by me to be incorporated into new designs.

Hands on trouble shooting of electromechanical on bench shop devices. Highly skilled hands on shop practices without supervision. Worked within a cross functional group of people.

Senior Mechanical Design Engineer ClearMotion Inc. Billerica MA August 2018 Dec2018 Contract basis with TriMech

Mechanical Design and drafting of suspension systems such as shock mounts for various high end automobiles.

Design of mechanical fluid systems with the application of o-rings and various tube type products.

Design of mechanical testing fixture apparatuses for testing of durability shock mounts design.

Created detailed, high quality technical documentation to capture and communicate designs

Collaborated technical knowledge with others in the team and other existing projects.

Experience with revision control and Jira systems

Design of suspension systems using Solidworks 2019 and PDM vault database.

Application of tolerances, GDT, drafting standards.

Sr. Mechanical Design Engineer Ledvance LLC. Wilmington, MA August 2016 to May 2018 full time. Company Wide Lay off

Engineering design of consumables LED bulbs and electrical drivers using Solidworks 2017

Created led bulb documentation to meet ANSI standards and apply GD&T standards for product information management.

Initiated mechanical inspection report system of incoming vendor supplied product.

Operated and maintained operation of 3D printer for continues use for product development design.

Design transfer from PRO-E to Solidworks via IGES formats and or redesign to Solidworks

Experience with mechanisms and precision mechanical designs of LED bulb design and opto-mechanical engineering.

Application of sheet metal fabrication, castings, plastic injection molding, and machining processes.

Strong oral and written communication skills, including strong presentation skills.

Senior Mechanical Engineer R&D, Insulet Corp. Billerica, MA May 2016 to August 2016 Contract.

Short term project to help in the R&D aspect of designing fixtures and drug delivery ideas for a concept evaluation. Stated to be a Short Term Contract Only.

Engineering design for mechanical drug delivery devices to be used for Humira, Medimmune drug delivery in diabetic POD device.

Create ideas of pod designs to be used as examples for product architecture.

Define and develop over all usability for human factors for design. Create and or change new methods for drug delivery based on form fit and function criteria such as ergonomics and physiological use.

Mechanical design, prototyping, and proof-of-concept analysis of complex mechanical drug delivery for 5 10 and 15 ml dose drug.

Develop test procedures and protocols for proof of concept. Define FEMA in designs with inside with other collaborators.

Knowledge of different types of drug delivery methods for injection.

Design tooling iterations of the insulin based product and set up feasibility tests.

Design of needle forming fixtures for product R&D designs.

Design of needle bending forming fixtures.

Conduct tolerance stack up analysis on existing and new designs.

Engineering design of test fixtures for micro fluidics and the application of springs design for product qualification.

Design of prototype concepts for product evaluation and qualification in Solidworks and Creo.

Assist in the procurement of device components that meet specifications.

Participate in product design reviews.

Developed tooling for construction of components and assembly of current future products.

Create and manipulate assemblies within CAD packages in Solidworks 2016 and Creo 3.0 and EPDM

Senior Mechanical Design Engineer, L3 Security and Detection Systems Inc. Woburn, MA Contract Aug15 to Jan16

Client requested to hire a contract employee only as this position was stated for 5month project based on of project need and based funding.

Redesigned a highly complex X-ray sensor array sled for cost reduction efforts. Reduced cost of design from $8,500 to for a price goal of $1800 or less, achieved goal was arrived at $1500 each for manufacturing.

Establish unknown engineering design requirements based off of current design and interpret key mechanical criteria to be successful in maintaining a goal oriented product for cost savings.

Coordinated with the supervisor for design and exact specification requirements advising on production requirements and documentation.

Implemented design using Solidworks 2015 wire routing and Vault to maintain a PDM control of all cad files and mechanical FEA analysis.

Mechanical cad models where documented using Solidworks drawings. Mechanisms such as linear rails,pillow blocks,ball end screws and electro mechanical actuators. Design of sheet metal and electro mechanical parts and assemblies. Established GDT directives to all mechanical models and drawings and checked into vault PDM.

Communicated with superiors on time goal and project status updates.

Present final assembly of sensor array sled to team members for final review and manufacturing.

Product Mechanical Design Engineer, Gotinterface Inc./Printec Inc. Waltham, MA Contract Sept 14 to Feb 15.

Hired to design and develop a device only for manufacturing. Project was cancelled due to internal financial funding

Design composed of complete plastics design introducing the integration of FPC, LCD, Flex Circuit design, Surfacing,knitting, manufacturing drawings, label application, bosses, IMD application, fastening and interlock design. Component introduction of design of barrel jack circuitry and micro usb.

Human factors considerations form fit and function for ergonomic use, Size of demo actual I-pad size.

Sole designer of company demo project to complete product launch.

Worked with timelines, milestones and budget requirements for demo device production.

Managed resources, assuring that timelines and budget were met at all times.

Coordinated with the project manager for design and exact specification requirements advising on production requirements and documenting changes and issues.

Identified key requirements for product review and plans, working with documentation and teams cross functionally.

Assured that product specifications, timelines and budgets were properly documented and tracked.

Provided routine communication via email, and in person meetings to set up milestones and track product progress.

Managed detailed documents, tasks and daily collaborations to assure product specifications were met in a timely manner.

Demonstrated the ability to design an effective product with management and to create new ideas in surfacing design.

Product design of company display demo using Solidworks 2014.

Proof of concept design using high end 3D print equipment to show form, fit and function.

Designed 3D material fixtures for LCD displays.

Design of IR switch application circuitry used in display demo.

Other projects consisted of IR touch for window interaction including sound, speaker application, testing and verification and manufacturing.

Senior Product Mechanical Design Engineer, Lantos Technologies. Inc. Wakefield, MA Contract Aug 13 April 14

Client’s objective was to hire a short term contractor to design new consumables for their device only based off of timelines and budget constraints.

Worked with global requirements including CE standards for medical product specifications.

Communicated cross functionally with project team to assure timeline, budget and resources were being managed in accordance with product requirements.

Assured that all detailed documentation was managed and tracked for product specifications, changes and production on time.

Tracked the progress of the product on the timeline and budget basis as well as tracked resources were on time and production was running smoothly.

Design product for ear canal scanning for devices used in earphones, hearing aids, safety devices.

Team member development engineer focused on delivering mechanical designs for product development for high volume consumables.

Focused on mechanical design for proof of concept medical device consumables, design of opto-mechanical motion control calibration equipment, plastic/silicon, fluid containment bags, and mechanical migration of fluid, products and design of electro-mechanical assemblies.

Product design and delivery of high volume products for pilot builds of over 10,000 in consumable pieces. Solved various engineering problems with associated form fit and function of medical device design for manufacturing. FMEA application to consumables and other products from designs

Design of fixtures related to IR assembly testing and verification equipment.

Solved molding issues related to mold design for quality product delivery.

Solidworks 2013 CAD design of surfaces, lofts, for newly design parts for application to current design

Devised protocols for shipping, packaging and impact testing for consumables. Convey validation, testing procedures for various devices designed.

Redesigned motion control fixtures for improved repeatability in the calibration of optical scanning devices.

Design of servo lift elevator for the movement of fluid to consumable.

Senior Mechanical Engineer Teradyne, Inc. North Reading, MA Contract Jan13 - August 13

Hired to perform investigational engineering work for only 3 months then got transferred to NPI, Teradyne closed all contractor help do to a high contract bid loss so had to lay off its contract employees.

Performed investigational internal resolutions to quality production requirements and with internal customer issues with released products for manufacturing. Integrated with various sustaining engineering departments to provide real engineering solving problems to meet DFM value and cost down streaming initiatives.

Collaborated with operational managers to resolve manufacturing issues with foreign products manufactured to be delivered for sale in the USA in conjunction with supply chain initiatives.

Provided product development consulting on new released capital testing equipment from foreign manufactures. Resolved technical design issues pertaining to EM packaging, sheet metal design, mechanical integration of parts and mechanisms that move axes used linear rails actuators, etc. large complex mechanical assemblies.

Devised best course of action to remediate current issues with electro/mechanical and electrical problems and its requirements.

Recommended changes in design for manufacturing based on DFM/DFA design principles. Investigated fabrication and remediate large and small casting DFM problems with supply chain team for technical fit and tolerance analysis and solved these issues with foreign manufactures.

Individual role was transferred internally to NPI for new development of semiconductor testing. Responsibility to solve current issues and bugs found in manufacturing of newly designed engineering high level assemblies.

Application of FEA to determine stresses and strains on various parts for design change when ECO's where established.

Project design of PCB on cold plates to determine best population on current platforms. Heat transfer and thermal analysis on platform design validation.

Semiconductor systems experience in instrumentation design for chassis design for hardware interfacing.

Analyzed current machined design drawing documentation to meet ANSI Y14.5 GD&T adherence. Solidworks 2012, Smarteam and PRO-E Creo 2.0 Windchill.

Opto-Mechanical Design Engineer Dimensional Photonics International,Inc. Wilmington, MA Contract Jan12-Aug12

Contract was completed do to its design and budget, for a 6-8 month contract based off budget criteria, company was bought out and company is now closed and no longer in business but has moved out of state.

Re-engineered existing electro mechanical complex equipment using Solidworks 2013 CAD machine design models and performed risk assessment to opto-electro/mechanical calibration components for a three-dimensional (3D) motion controlled measurement system for a hand held IR intra oral dental scanning device.

Reduced existing mechanical machined errors to kinematic mounts and improved IR triangulation integration of motion control hardware for calibration and verification of optical mechanical alignment testing within the calibration station. Provided internal FEA/DFMEA criteria to the redesign for manufactured components for production.

Plastic part design of various electromechanical enclosures, parts connectors, ribs bosses, containment fixtures.

Designed sheet metal supports/chassis parts etc for PCB boards to provide efficient air cooling flow through the entire thermal management redesign electromechanical package. Emphasis on IEC 60601-2-2 for medical device Class III. Re-evaluated existing documentation and corrected current mechanical drawings from any inefficiencies for transitioning work to internal/external vendors and for production manufacturing. Collaborate with machinist for component fabricating for mechanical optical fixtures and sheet metal parts.

Mechanical Design Engineer Conformis Inc. Burlington, MA Contract Nov11-Dec 11

Hired to help in CAD design and drafting while a current employee was out on leave. No opportunity for fulltime employment

Directed goal was to design and document various combinations of orthopedic knee joint implants such as cast tibial interlock shelfs and high density polyurethane plastic knee inserts for iTotal® knee implants for product release and manufacturing within a R&D department. Created multiple Solidworks 2011 CAD configurations of models and drawings for the support of DHF/PDM quality systems and marketing.

Mechanical/Manufacturing Design Engineer Arsenal Medical Inc. Watertown, MA Contract May11-Nov11

Hired to help and aid in CAD design and development of their stent based product for manufacturing and support ongoing issues with manufacturing. This was only a contract based project to help meet the needs of personnel only.

Developed mechanical fixtures for the aid in manufacturing, test and inspection for a polymer based FIMA stent for clinical trials.

Design for the application of 80/20 parts to modify existing equipment for automation

Specification, sourcing, and application of machine designed specialized parts and sensors for automation application for stent coating.

Reengineered electro mechanical coating automation equipment to aid in the install of stents for polymer coating in customized process PLC mechanical automation equipment. Guide and support pilot manufacturing builds including actual building and performed internal QC inspection criteria. Test devices and analyze results using various electromechanical radial force equipment to gather statistical data analysis. Wrote and created work instructions for various manufacturing hands on assembly as well as for the use of sterility operations and procedures.

Took lead responsibility in providing validation of clean room manufacturing and it sustainment of meeting standards for ISO 7 8 9.

Mechanical Design Engineer Valeritas Inc. Shrewsbury, MA Long Term Contract Sept 09 - Feb 11

Project cancelled for continuing further manufacturing due to financial backing from supporting drug company who was supporting the program.

Lead product development design lifecycle and creation of a disposable micro-needle medical device used for hormone treatment for clinical trials.

Designed various multi-forming tools for needles and provided proof and verification to the design and risk analysis.

Designed plastic pod case packaging for the containment of holding a micro-needle array and other medical components included researching medical grade plastics and textile materials for product development and manufacturing. Design of optical measurement and locations of drug on needle array using cameras and vision locations systems on robotic XY platform table.

Designed hand actuating mechanism for the application of a mircro needle to the epidermis layer of skin. Experience working in and creating documentation for medical device design control systems.

Design of equipment for EDM and chemical etched products.

DFMEA to DHF and product development.

Created DHF for QC initiatives in the document control of products designed for clinical trials. Developed ECO’s/DCN for the creation of drawings for initial release for development and manufacturing of medical goods quality systems. Designed newly created clean room and assembly fixtures for manufacturing production initiatives. Experienced with designing micro fluidic instrumentation devices actuating mechanisms for drug dispensing. Extensive Solidworks use with version 2010-11 and GD&T adherence.

Designer/Private Consultant Logan Instruments,Inc., Everett, MA Contract Feb09 to April 09

Short term project to design some new devices to help them get up to speed. No opportunity for fulltime as was noted in the beginning.

Using Solidworks 2009, Custom designed hand surgical devices specializing in neurosurgical and orthopedic applications such as Curettes, Tapered Suction Tubes, Elevators Dissectors, Retractors, Nerve Hooks, Nerve Root Retractors, Arthroplasty Gouges and specialized instruments. Performed verified GD&T tolerances to new and old drawings and provided the update to device history files. Performed internal investigations on current designs for manufacturing validation procedures for continues onsite improvement to promote FDA compliancy and ISO 9001:2000 compliancy.

Senior Mechanical Designer American Science and Engineering, Billerica, MA Contract October08 to Dec08

Short term position to help in sustaining the project needs. No opportunity for fulltime position as stated in the beginning due to hiring constraints.

Using Soldiworks 2007 performed mechanical designs of machined parts, sheet metal parts, aluminum castings, weldments and fasteners incorporated into large and small mechanical capital equipment assemblies. Performed ECO revisions with the aid of SmarTeam PDM software. Manipulated sketches to reflect changes within parts and assemblies. GD&T application of new and revised drawings.

Supply Development Engineer Nuvera Fuel Cells, Billerica, MA Contract Feb08 to June08

Short term only to help supply chain efforts in there logistics platform to help them through launch.

Responsible to ensure materials are available on a timely basis to fully support all manufacturing, product development and R&D activities. Prepared request for proposals, bids and other similar and necessary documents related to the purchasing of product to support manufacturing, product development and R&D.

Analyze quotations for new components from current or new suppliers in a manner that is consistent with the sourcing strategy. Worked with Solidworks 2008 to implement drawing packages from PDM packages. Submitted drawings to suppliers for quotes using PDX package processing. Worked with various customers to manufacture mechanical products, electrical board fabrication, software and cable routing harnesses. Assisted suppliers to ensure that selection, development, and validation of manufacturing processes, equipment and tooling are performed to the meet engineering requirements. Initiated SCAR to customers that need to change or improve on their manufacturing process or procedures.

Mechanical/Manufacturing Design Engineer Bausch & Lomb, Wilmington, MA Contract Oct07 to Feb 08

Hired to develop cleaning process equipment. Company had layoffs to reduce size and did not need to hire full time employees.

Designed and created soft lens cleaning manufacturing process equipment to be used in lens manufacturing facilities.

Hands on design for fluid distribution for various mechanical components application of pumps, piping, fittings and control valves

Collaborate with outside machine shops to manufacture multiple parts and devices. Engineering and project management skills in the scale-up of new products, the improvement and refinement of existing processes and equipment and the support of existing manufacturing operations.

Performed in-house R&D development of such fixtures and the application of electro/mechanical components such as pumps, adapters and specialized fittings and sheet metal parts using Solidworks 2008.

Mechanical Engineer Wyeth Pharmaceuticals Co., Andover, MA Contract November 06 to April 07

Program was to identify devices throughout the company as long as it took. This was strictly a short term contract only.

Under very limited supervision of the Directing Manager of Utilities and Production Services, I successfully and individually performed intense onsite investigations of mechanical water and Low and High steam process equipment needed for VPP safety evaluation. Logistically located and identified all the safety devices on P&ID’s using current company maintenance and other software for investigational and validation purposes. Communicated with all working EVM and MEM departments to investigate, identify and compile all safety devices for corporate review and evaluation. This included collaboration with building facilities, planning and engineering services.

Mechanical Design Engineer Osmetech MDD Inc., Rockland, MA ContractMay 06 to Oct 06

Contract to help support the development of their equipment. Completed the task.

Mid and late-stage development and technology transfer activities for an in process FDA approved genetic medical temperature test instrumentation(FlowCytoMetry) and plastic (vials) consumables for laboratory and in-vitro diagnostic applications. Worked with various manufactures to implement product take off and market.

Established FAI for tooling for product consumables and acceptance for tooling. Approved or disapproved the acceptance of tooling production. Provide the technical support and input to purchasing and material/component part suppliers. Obtained and prepared materials needed to carry out consumable parts and medical genetic test laboratory using equipment evaluations.

Analysis of thermal and air flow characteristics around vial for validation and verification. Vial design to compete with Roch Diagnostic devices.

Carried out specified prototyping, formulated product testing, tooling/ fixturing design, generated test protocols/reports, data analysis and provided assistance in process validations. Drafted instructions for equipment use and standard procedures, material specifications and equipment specifications as needed. Provided cGMP validation of procedures and incorporated documentation of various SOP for maintenance of environmental clean rooms. Provided technical and logistical support as required in all phases of product development life cycle.

Engineered Products:

Mechanical engineering designs beginning with new and late stage product development, new product design lifecycle and introduction of new products, procurement, supply chain directives, mechanical design and integrated processes.

Designs models and evaluation for verification include: capital equipment, electromechanical parts/assemblies, optical alignment test design for calibration, process cleaning equipment, medical devices, plastic medical consumable goods, dental scanning equipment, blood analyzers, micro molding, micro-needle design and micro-fluidic instruments, diagnostic equipment, piping/electrical, schematics, respiratory equipment, safety equipment, actuating mechanisms and, moving parts, robotic equipment, machines parts, fixtures, large sheet metal parts for assemblies to hold electromechanical components on chassis, weldments, plastics and surgical instruments.

EDUCATION AND MILITARY

Wentworth Institute of Technology, Boston, MA Bachelor of Science Degree in Mechanical and Minor in Manufacturing Engineering

Military Duty, Honorable Discharge Air Force Air National Guard 7 years

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