Todd Molander Email & Phone Number

Andover, Massachusetts, United States

- Products: Sports Medicine implants / Surgical instruments / Regeneten Shoulder repair surgery kits: Implants, Tendon anchors, & Bone anchors with delivery instruments - Provided R&D and packaging operational support for manufacturing & distribution facilities located in Memphis, TN / San Jose, Costa Rica / Belgium / Switzerland / China- Directed project management of packaging design for medical devices from prototype & new product development, to end design of packaging, through… Show more - Products: Sports Medicine implants / Surgical instruments / Regeneten Shoulder repair surgery kits: Implants, Tendon anchors, & Bone anchors with delivery instruments - Provided R&D and packaging operational support for manufacturing & distribution facilities located in Memphis, TN / San Jose, Costa Rica / Belgium / Switzerland / China- Directed project management of packaging design for medical devices from prototype & new product development, to end design of packaging, through final process validation and manufacturing implementation. Show less

Memphis, Tennessee

- Products: Spinal implants / Surgical instruments / Spinal Kyphoplasty bone filler kits / Bone cement / Procedure sterilization loaner set trays- Provided R&D and packaging operational support for manufacturing & distribution facilities located in Warsaw, IN / Memphis, TN / Humacao, Puerto Rico / Kerkrade, Netherlands / Neuchatel, Switzerland / China- Directed project management of packaging design for spinal medical devices from prototype & new product development, to end design of… Show more - Products: Spinal implants / Surgical instruments / Spinal Kyphoplasty bone filler kits / Bone cement / Procedure sterilization loaner set trays- Provided R&D and packaging operational support for manufacturing & distribution facilities located in Warsaw, IN / Memphis, TN / Humacao, Puerto Rico / Kerkrade, Netherlands / Neuchatel, Switzerland / China- Directed project management of packaging design for spinal medical devices from prototype & new product development, to end design of packaging, through final process validation and manufacturing implementation.- Streamlined manufacturing processes with outside supplier sterile pouch and thermoformed tray packaging lines for bone filler products and combined similar kit packing lines, lowering the quantity of required on-site stock leading to $150K cost savings per year.- Provided packaging support for EU MDR corporate project team working to define impacts to all related product packaging artwork, labeling, and IFUs.- Coordinated with cross-functional project team to move packing lines for Kyphoplasty cement delivery system kits and bone cement mixer kits from different outside suppliers to Medtronic in-house manufacturing site, gaining annual cost savings exceeding $550K.- Assisted corporate planning team with movement of sterile packaging manufacturing lines from various outside suppliers to existing Medtronic mfg site, directing packaging efforts to revalidate all sealing machines, update risk levels on DFMEAs, and performing new pkg Distribution testing, annual cost savings of $900K.- Completed Lean Sigma green belt training for Six Sigma. Show less

Memphis, Tennessee

- Products: Spinal implants / Surgical instruments / Bone cement- Provided support for Manufacturing & distribution facilities located in Warsaw, IN / Memphis, TN / Humacao, Puerto Rico / Neuchatel, Switzerland / China- Directed project management of packaging design and development for spinal medical device implants.- Completed packaging process validation improvements for outside suppliers of sterile bone cement products and teamed with supplier QA to use statistical process… Show more - Products: Spinal implants / Surgical instruments / Bone cement- Provided support for Manufacturing & distribution facilities located in Warsaw, IN / Memphis, TN / Humacao, Puerto Rico / Neuchatel, Switzerland / China- Directed project management of packaging design and development for spinal medical device implants.- Completed packaging process validation improvements for outside suppliers of sterile bone cement products and teamed with supplier QA to use statistical process controls to record on-going mfg process, decreasing quality holds & back-orders to save more than $100K per year. Show less

Marlborough, Massachusetts

- Products: Women’s health devices & surgical procedure kits / Endoscopic medical devices- Supported Manufacturing sites in Indiana / Massachusetts / Cork & Galway, Ireland / Coyol & Heredia, Costa Rica / Kerkrade, Netherlands / Tokyo, Japan- Furnished packaging design responsibility to project teams during manufacturing lines moving from US to new Costa Rica site.- Implemented project team leadership for labeling/graphics update to new corporate master brand format impacting all… Show more - Products: Women’s health devices & surgical procedure kits / Endoscopic medical devices- Supported Manufacturing sites in Indiana / Massachusetts / Cork & Galway, Ireland / Coyol & Heredia, Costa Rica / Kerkrade, Netherlands / Tokyo, Japan- Furnished packaging design responsibility to project teams during manufacturing lines moving from US to new Costa Rica site.- Implemented project team leadership for labeling/graphics update to new corporate master brand format impacting all packaging component levels (inner sterile to outer cartons) including IFUs and documented design change analysis for Regulatory filings. - Facilitated operational value improvement team management with MFG engineering groups from production sites in both Indiana and Costa Rica for pkg sustaining enhancements and equipment upgrades, saving over $150,000 for each of last three years. - Identified process validation areas for improvement with QA relating to outside suppliers of sterile packaging materials, worked to better define statistical process controls, and developed procedures to connect pkg part minimums to all new design validations.- Experienced in affects of ethylene oxide/gamma radiation/gas plasma/steam/H2O2 sterilization on medical packaging materials. Show less

Warsaw, Indiana

- Products: Orthopaedic Hip / Knee / Ankle / Shoulder / Trauma implants- Supported Manufacturing sites in Warsaw, IN / Raynham, MA / Miami, FL / Cork, Ireland / Le Locle, Switzerland / Suzhou, China- Provided project management of sterile medical device packaging for Hip and Trauma/Extremity implants from prototype and new product development, to end design of packaging, through final process validation and manufacturing implementation.- Launched new global label formats with 1D… Show more - Products: Orthopaedic Hip / Knee / Ankle / Shoulder / Trauma implants- Supported Manufacturing sites in Warsaw, IN / Raynham, MA / Miami, FL / Cork, Ireland / Le Locle, Switzerland / Suzhou, China- Provided project management of sterile medical device packaging for Hip and Trauma/Extremity implants from prototype and new product development, to end design of packaging, through final process validation and manufacturing implementation.- Launched new global label formats with 1D barcodes/2D Data Matrix Auto-ID symbols for all product lines in coordination with Logistics & Sales use of handheld PDA label scanners for new “Instant Update” worldwide inventory reorder program.- Developed and implemented new sterile hybrid package (Inner-flexible pouch/Outer-rigid blister tray) design for Hip implants consolidating 7 older pkg designs in worldwide US, UK, & China plants.- Trained new packaging engineers for MFG facility in China, wrote all pkg process validation protocols, and headed operational team tasked with setting up new & moving existing pkg production lines from UK to China within required project timelines.- Coordinated integration of pkg BOMs & material specifications for 500+ product codes after purchase of Hand Innovations Inc.- Teamed with Regulatory Affairs to provide packaging validation & shelf life documentation to upgrade Hip implants to Class III. Show less

Memphis, Tennessee

- Products: Orthopaedic Hip / Knee / Trauma implants / Hyaluronic Acid injectables- Supported Manufacturing sites in Memphis, TN / Leeds, United Kingdom / Tuttlingen, Germany- Project team leader during development & integration of automated pouch (clean room) / carton (outside) packaging line in Knee MFG enabling plastic implant products to be changed from rigid blister trays to pouches.- Set-up new on-site Packaging Test Lab consisting of Lansmont Drop Tester and Vibration Table… Show more - Products: Orthopaedic Hip / Knee / Trauma implants / Hyaluronic Acid injectables- Supported Manufacturing sites in Memphis, TN / Leeds, United Kingdom / Tuttlingen, Germany- Project team leader during development & integration of automated pouch (clean room) / carton (outside) packaging line in Knee MFG enabling plastic implant products to be changed from rigid blister trays to pouches.- Set-up new on-site Packaging Test Lab consisting of Lansmont Drop Tester and Vibration Table for distribution simulation by defining required equipment and setting up lab space in new facility.- Assisted MFG & QA with launch of on-site vaporized hydrogen peroxide (H2O2) sterilization process eliminating 14 days of UHMWPE plastic product in-process delay from post-sterilization testing resulting in annualized cost savings of $550,000.- Managed 2 technicians and 1 intern who supported Manufacturing, new product development testing, & label format/graphics.- Directed packaging project support for all new product development for global sales of Reconstruction (total hip, knee & shoulder joint replacement implants) & Trauma external/internal fixation (bone fracture nails, plates & screws) parts.- Implemented supplemental labeling system for European distribution center in France adding 4 new languages to current capability of 5 primary and increased size of translation database to 1200 English keywords translated now into 9 languages.- Established system to allocate and schedule-by-priority departmental engineer resources for new product development projects to maintain closer alignment with strategic company goals, better define Packaging Development milestones, and provide enhanced monthly reporting communication to upper management concerning timelines for all new product launches. Show less

Wayne, New Jersey

- Products: Vascular grafts and Endovascular stents- Supported Manufacturing sites in Wayne, NJ / Maple Grove, MN / Galway, Ireland- Directed project management of new product development for sterile packaging of vascular grafts and endovascular stents.- Instituted new Labeling Print-On-Demand system using thermal transfer printers initiating use of labor-saving multiple label sets with 11 language text translations & international symbols resulting in 50% faster shop order release… Show more - Products: Vascular grafts and Endovascular stents- Supported Manufacturing sites in Wayne, NJ / Maple Grove, MN / Galway, Ireland- Directed project management of new product development for sterile packaging of vascular grafts and endovascular stents.- Instituted new Labeling Print-On-Demand system using thermal transfer printers initiating use of labor-saving multiple label sets with 11 language text translations & international symbols resulting in 50% faster shop order release time and better lot control.- Conducted Process Validation (DQ, IQ, OQ, PQ) for all packaging lines during move to new facility within required timelines.- Evaluated and implemented “Clear-Foil” SiOx multi-layer plastic overwrap to limit moisture absorption by new impregnated vascular graft product line, extending shelf life by 5 years and reducing product scrap rate for annual cost savings of $325,000.- Managed team (2 technicians & 1 label graphics administrator) that supported MFG and new product development projects. Show less

Franklin Lakes, New Jersey

- Products: Sutures & Needles / Pre-filled Syringes / Surgical Scrub brushes- Supported Manufacturing sites in Sandy, UT / Canaan, CT / Hancock, NY / Dublin, Ireland- Directed technical research plan to trial and develop “high moisture retention” poly-foil material to be used on form/fill/seal MFG system to fulfill FDA New Drug Application, PMA, & 510(k) requirements for impregnated surgical scrub brush products.- Led cost reduction program as project team leader for surgical scrub… Show more - Products: Sutures & Needles / Pre-filled Syringes / Surgical Scrub brushes- Supported Manufacturing sites in Sandy, UT / Canaan, CT / Hancock, NY / Dublin, Ireland- Directed technical research plan to trial and develop “high moisture retention” poly-foil material to be used on form/fill/seal MFG system to fulfill FDA New Drug Application, PMA, & 510(k) requirements for impregnated surgical scrub brush products.- Led cost reduction program as project team leader for surgical scrub product lines, developed test protocols for foil & poly film material comparison screening, completed process validation and MFG start-up resulting in annualized saving of $450,000.- Supplied technical expertise as team leader to projects for semi-automated high-speed Form/Fill/Seal packaging production lines, manual package sealing (heat & induction) operations for pouches/blister trays, and all other related packaging materials. Show less

Cranston, Rhode Island

- Products: Blood Bags/Filters for Reinfusion / Blood Filtration Sets / Suction-Irrigation Kits / Suction-Irrigation Instruments- Supported Manufacturing sites in Cranston, RI / Lawrence, KS / Juarez, Mexico- Provided packaging support for plant manufacturing & QA in Kansas and Mexico sites during transfer of packaging production lines (Form/Fill/Seal, semi-automated pkg lines, and blister tray sealing shuttle) and established improved MFG procedures.- Implemented new Labeling… Show more - Products: Blood Bags/Filters for Reinfusion / Blood Filtration Sets / Suction-Irrigation Kits / Suction-Irrigation Instruments- Supported Manufacturing sites in Cranston, RI / Lawrence, KS / Juarez, Mexico- Provided packaging support for plant manufacturing & QA in Kansas and Mexico sites during transfer of packaging production lines (Form/Fill/Seal, semi-automated pkg lines, and blister tray sealing shuttle) and established improved MFG procedures.- Implemented new Labeling Print-On-Demand system with primary HIBC (Health Industry Barcodes) barcodes in multiple MFG areas eliminating existing hard to access label storage room by using generic blank labelstock instead of preprinted labels on majority of products, decreasing individual shop order time by 20% resulting in cost savings of $275,000.- Spearheaded concurrent engineering activity between R&D, Engineering, QA, and MFG through Product Development teams resulting in 25% faster implementation during new product launches and integration of acquired company’s existing products.- Exceeded corporate annual cost saving goal of $200,000 for individual engineers for three straight years.- Merged 2 person graphic design team into Packaging Department through development of new computer-generated artwork system decreasing artwork completion lead-time from 14+ days to 3 days. Show less