Stan Needle Email & Phone Number

Boulder, Colorado, United States

Designing & commercializing next-generation pulse-oximetry equipment.

Greater Denver Area

Provides 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.

Boulder, Colorado, United States

Transforming complex ideas and needs into commercial products through ideation, defining requirements, multidisciplinary team coordination, IP development, supplier management, project management, and transfer to production.

Greater Denver Area

New 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.

Boulder, CO

Developed 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.

Boulder, CO

Moved 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.

Louisville, CO

Assisted clients with design and manufacturing projects.

• 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.
• 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.

Greater 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.
• 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.
• 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.

• 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.
• 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.
• For another client, designed and performed a 5-level, half-factorial experiment to optimize the manufacturing process for a complex nitinol implantable medical device.

• 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.
• 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.
• 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.

• 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.
• 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.
• 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.

• 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.
• Awards: Winner of 1996 Bicycle of the Year, Mountain Bike Action Magazine.

Created 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.

Msme, Mechanical Engineering

Bsme, Mechanical Engineering