Stan Needle Email and Phone Number
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Product Development Mechanical Engineer / Project Manager with over 30 years of experience primarily developing life science products used in a wide range of pharmaceutical, electrosurgical, drug delivery, endovascular, and neurovascular applications. As a mechanical engineer with a Swiss Army knife of skills, I transform the voice of the customer into concepts that are advanced through IP development, design, testing, product launch and into production. As a project manager, I can juggle and coordinate all aspects of the project to stay within schedule and budget constraints, while following FDA and ISO requirements. I can assist your project with any or all of the following phases:► Project planning, scheduling, and budgeting► Ideation, concept development and IP creation► Mechanical design (solid models to complete drawings)► Electrical & software integration► Design control documents: user requirements, design specifications, risk analysis, FMEA…► Prototyping (cosmetic and functional)► Test & analysis ► Development of production samples► Design & development of manufacturing systems, fixtures, procedures► Process development & pilot production► V&V protocols: validation master plan, design verification and process validation protocols► Test coordination (through your internal laboratory and/or external testing firms)► Data analysis (with advanced statistics)► V&V reports► User evaluations (design validation)► Design transfer documentation (for production)Specialties: ► Transforming the voice of the customer into user requirements and design specifications.► Knowledge of materials (biocompatible polymers, metals, and composites), their manufacturing methods (injection molding, machining...), and their sterilization methods used in medical applications.► Proficient in SolidWorks design software.► Experienced with Minitab statistical software.►Instrumentation system design and data analysis (digital & analog)►Measurement system analysis► Excellent understanding of NiTi principles.
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Principal Mechanical EngineerZynex Monitoring Solutions Oct 2023 - PresentBoulder, Colorado, United StatesDesigning & commercializing next-generation pulse-oximetry equipment.
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Principal Consultant | Product Development Mechanical EngineerConcept To Production, Llc Nov 2013 - PresentGreater Denver AreaProvides product development - mechanical engineering solutions for a variety of industries, from concept initiation to production. » Sudhin Biopharma: Managed the design, development and initial builds of biopharmaceutical manufacturing equipment. Secured project by establishing a highly detailed multi-phase product development proposal.» CME America: Managed design changes to infusion pump accessories as production was moved from overseas to internal operations. Provided regulatory compliance analysis for multiple projects (infusion pump design changes & software development/implementation). Resolved supplier quality problems through engineering analysis, design guidance and CAPA closure.» Kaleidoscope: Designed a stent delivery system handle for their customer. Both Kaleidoscope and their customer were highly satisfied with the clever mechanisms, attention to detail, manufacturability, and rapid closure of the design phase.» Creation Technologies: Provided conceptual & detailed SolidWorks models (100+ component assembly), plus complex feasibility studies for an automated pill identification system for a startup firm. Developed a compressed, yet full project schedule to bring the system into production.» Bard Medical: In a manufacturing engineering role, supported production relocation to Mexico. This involved equipment upgrades, test method development/validation, supporting automated equipment issues, and resolving supplier quality problems.
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Advanced Lead Mechanical EngineerVeolia Water Technologies & Solutions Jan 2017 - Oct 2023Boulder, Colorado, United StatesTransforming complex ideas and needs into commercial products through ideation, defining requirements, multidisciplinary team coordination, IP development, supplier management, project management, and transfer to production. -
Sr. R&D EngineerSurefire Medical, Inc. Jun 2014 - Sep 2015Greater Denver AreaNew Product Development for early stage company: contributed to the development of a breakthrough infusion catheter, intended for the delivery of embolic beads for the treatment of liver cancer. Through numerous iterations and user studies, designed a new catheter handset/delivery system that enables precisely controlled actuation of the expandable tip of the catheter, while providing reliable high pressure seals at both the infusion and intermediate access ports. This novel high profile device became the best-seller in the company’s portfolio, and has enjoyed the highest yield of any product on the manufacturing floor. -
Principal EngineerEndoshape, Inc. Nov 2011 - Oct 2013Boulder, CoDeveloped endovascular devices utilizing proprietary shape memory polymer. Advanced implant and delivery system from prototype to successful First-In-Man device. Designed, developed, built, and validated a new handset for commercial release of product. Handset performed 8 functions with 11 injection molded components, and 6 process validations.
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Engineering ManagerBoulder Biomed / Sophono Aug 2010 - Oct 2011Boulder, CoMoved production from Germany to Boulder, CO, and ramped up production to a 4X rate with 2X staff. Starting from scratch, implemented operational controls to ISO 13485 standards. Designed, developed, and produced new products and accessories for the bone-anchored hearing aid market.
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Owner / ConsultantConcept To Production Mar 2010 - Oct 2010Louisville, CoAssisted clients with design and manufacturing projects.
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Sr. Project EngineerEncision Oct 2006 - Mar 2010● Propelled the development of the company’s most complex project to date (disposable suction/irrigation electrode, an electrosurgical instrument for laparoscopy) into a family of 3 disposable products with a total of 15 product codes.● Managed a cross functional team, $500K budget, and an aggressive schedule.● Project involved a significant level of interaction with surgeons, and generated strategic IP for the company.● Starting with only concepts, created designs, prototypes, and production models. Created all DHF documentation, plus V&V plans / protocols / reports.● The finished device involved 19 custom injection-molded parts and a total of 53 new components, which required managing six new and 15 existing domestic & overseas suppliers.● Created and coordinated a complex V&V plan with multiple suppliers and contract manufacturers. ● Utilizing MiniTab software, introduced advanced statistical techniques into testing programs throughout the company. -
R&D Manager / Sr. R&D EngineerMckinley Medical Jan 2004 - Sep 2006Greater Denver Area● From concept to production, managed a team of 3 engineers and 1 technician responsible for the development of a disposable PCA (patient controlled analgesia) device, a drug delivery device used to self-administer pain medication following surgery. ● Created a fundamentally new operational concept for a PCA device. Evaluated the patent landscape, and wrote patent application with limited assistance from the patent attorney. (Controlled Volume Infusion Device, patent applied 11/05.)● Utilizing SolidWorks iteratively created a design which involved four complex custom injection-molded components. Also created IFU, part/package labels, and packaging.● Created new manufacturing methods which required custom automated equipment. Developed and documented the complete assembly process, then trained assemblers at a contract manufacturer in Mexico. ● Managed all DHF documents (drawings, specifications, labeling, procedures, protocols, reports…). ● Created and coordinated a complex process validation plan with the contract manufacturer. ● Planned the field evaluation portion of the design validation.
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Owner / ConsultantConcept To Production Jan 2003 - Jan 2004● Managed the development of an implantable nitinol laser cut tube-coil with two contract manufacturers. This involved an iterative process of designing, manufacturing, testing and documenting in preparation for a human trial (IDE).● Designed a blood flow valve with an .028" OD and .040" length. This implantable device, fabricated from laser cut nitinol tubing, was to be attached to the distal end of a coil such that blood flow through the lumen is prevented, yet insertion and retraction of an optical fiber is effortless. Client has since applied for patents: 1. Surgical Fastener. Patent applied 8/05 2. Apparatus and Method for Performing a Surgical Procedure. Patent applied 9/05. 3. Apparatus and Method for the Articulation of a Catheter. Patent applied 9/05.● For another client, designed and performed a 5-level, half-factorial experiment to optimize the manufacturing process for a complex nitinol implantable medical device.
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Project EngineerUti/Star Guide (Currently Lake Region Medical) Jul 2000 - Jan 2003● Charged with advancing company’s competitive edge in the medical device - coil components market:● Developed new production technologies, then designed and built corresponding automated equipment and fixtures. ● Provided product design assistance to customers for a variety of medical devices (e.g., helped one startup company with their product design, and fully developed the manufacturing process of an MP35N endovascular staple for abdominal aortic aneurysm stent grafts). ● Expanded the scope of manufacturing capabilities by developing and improving manufacturing processes for pacing leads, NiTi coils, secondary shaped coils, multi-filar conductor coils, and torque cables, which are all now part of the company’s standard product line.● Created a highly structured spreadsheet for automating the quotation process for coils and complex assemblies. This enabled far more accurate and competitive pricing than previously possible.
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Manufacturing EngineerBoston Scientific 1996 - 2000● Product Development: Responsible for designing and developing new products, testing methods, manufacturing processes, associated tooling, and automated equipment for the development of minimally invasive neurovascular and cardiovascular medical devices. With a key role in multidisciplinary new product introduction teams, took two new flagship products from concept to product launch.● Equipment Development: Designed automated production machinery with Pro-Engineer for both the development and manufacture of electrophysiology catheters and neurovascular coils. Managed the construction and implementation with local job shops, manufacturing engineers, and maintenance staff.● Managed the outsourcing of second and third generation automated coil winders, a $675K capital equipment project. Created operating specifications, coordinated the equipment qualification, implemented machines into production, and provided ongoing production support. -
R&D EngineerGt Bicycles 1994 - 1997● Responsible for the development of GT's line of suspension mountain bikes from concept through product launch. Planned and generated drawings, prototypes, and frame and component specifications under strict time-to-market deadlines. Coordinated the development with GT's manufacturing department, as well as local and Taiwanese manufacturers, as the designs were tested, qualified, and then produced. Patents: 1. Bicycle Flex Joint with Non-torsional Encasement: Issued 2/99. 2. Position Sensitive Friction Damper: Issued 7/97, and 5/96 in Taiwan. 3. Composite Bicycle Frame and Method of Manufacture: CIP issued 3/99, first issued 8/98. 4. Composite Bicycle Frame: Design patent issued 7/96.● Awards: Winner of 1996 Bicycle of the Year, Mountain Bike Action Magazine.
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Design EngineerRocketdyne Division Of Rockwell International (Currently Pratt & Whitney) May 1989 - Aug 1991Created and coordinated design changes to the liquid oxygen turbopumps of the Space Shuttle Main Engine, which included frequent interaction with NASA management. Also specified necessary redesigns and repairs for fluid handling equipment for rocket engine test stands.
Stan Needle Skills
Stan Needle Education Details
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Mechanical Engineering -
Mechanical Engineering
Frequently Asked Questions about Stan Needle
What company does Stan Needle work for?
Stan Needle works for Zynex Monitoring Solutions
What is Stan Needle's role at the current company?
Stan Needle's current role is Principal Mechanical Engineer at Zynex Monitoring Solutions.
What is Stan Needle's email address?
Stan Needle's email address is ne****@****att.net
What is Stan Needle's direct phone number?
Stan Needle's direct phone number is +130344*****
What schools did Stan Needle attend?
Stan Needle attended University Of California, Davis, Washington University In St. Louis.
What are some of Stan Needle's interests?
Stan Needle has interest in Environment.
What skills is Stan Needle known for?
Stan Needle has skills like Machining, Metals, Composites, Solidworks, Manufacturing, Program Management, R&d, Fda, Project Management, Design Control, Medical Devices, Product Development.
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