Steve Donnigan, Pe, Cpm, Msme Biomedical Engineering Email and Phone Number
Steve Donnigan, Pe, Cpm, Msme Biomedical Engineering work email
- Valid
- Valid
Steve Donnigan, Pe, Cpm, Msme Biomedical Engineering personal email
Steve Donnigan, Pe, Cpm, Msme Biomedical Engineering phone numbers
The path to medical device innovation is filled with obstacles - ▪️ Technical Challenges▪️ Focused Resources▪️ The Relentless Pressure To Get To Market QuicklyThese obstacles can easily overshadow promising ideas, turning potential innovations into unrealized or delayed dreams. It's crucial to find the right expertise to bring your visionary ideas to fruition. But that can introduce even more uncertainty to an already challenging process.The solution? A skilled partner who can navigate this complex terrain. A65 Consulting offers that expertise, bridging the gap between your innovative concept and a market-ready medical device. We transform complex challenges into successful, cutting-edge solutions, ensuring your innovative idea transcends from concept to a viable product, while effectively navigating the industry's hurdles. You can rest assured that no matter how big or small your challenges are, A65 is more than equipped to handle them.Our services include: ▪️ Mechanical Engineering▪️ System Engineering▪️ Manufacturing Engineering▪️ Project Management▪️ Interim Engineering Management▪️ Intellectual Property Review
A65 Consulting, Llc
View-
Founder And Principal ConsultantA65 Consulting, Llc Jan 2018 - PresentCastle Rock, UsFounder of small boutique medical device consulting firm specializing in providing full-service engineering on unique, innovative, and challenging products. Engineering leadership and services provided to clients contributed to over $200M of projected new product revenue, multiple FDA 510k submissions, numerous new patent applications, reduced complaint rates, and on-time completion of mission critical projects.Areas of design include:- Precision mechanisms - High volume disposables- Electromechanical systems- Complex robotic/automated systems Services include:- Mechanical engineering o Concept brainstorming through detailed engineering and product launch o FEA and classical engineering analysis o Tolerance analysis o SolidWorks CAD modeling and drawing creation- Systems engineering o Requirements definition o Risk management o Voice of customer (VOC) surveys/interviews o Human factors engineering- Project/program management o Schedule development and tracking o Expense and resource estimation and tracking o Cross functional leadership and management- Manufacturing engineering o Design for Manufacturing/Assembly (DFM/DFA) o Supplier selection/management and COGS estimation o Fixture and tooling development (manual and automated) o Root cause analysis and investigation of production problems- Intellectual property review o Patent reviews o Patent disclosures o Infringement reviews
-
R&D Engineering Manager, Advanced SurgicalConmed Corporation Apr 2015 - Mar 2018Largo (Tampa Bay), Fl, Us- Responsible for overseeing team of six mechanical engineers and one technician- Provided guidance on technical direction for high volume disposable surgical devices as well as mid volume capital equipment system development- Provided feedback on injection molded, sheet metal, and stamped part designs - Key contributor to design reviews and intellectual property reviews - Reviewed analysis (FEA, tolerance, CFD, etc.) conducted by team members- Led industrial design effort with outside contractor for next generation advanced energy hardware system- Led concept development of new surgical cart by outside contractor- Estimated product COGS and responsible for ensuring designs meet COGS targets- Drove SolidWorks CAD modeling and PDM best practices - Led development of product requirement generation, and product risk assessment - Program manager responsible for $11M, multi-year development of next generation advanced energy hardware and disposable products for surgical use- Led 20+ member cross functional team of R&D, marketing, quality, regulatory, manufacturing, and service members located in geographically diverse locations- Responsible for leading phase gate reviews, leadership team updates, and weekly CEO updates -
Project Manager, Sr. Principal Engineer & Principal EngineerBaxter Healthcare Jun 2008 - Apr 2015Deerfield, Illinois, Us- Managed and responsible for contract engineering company in multi-year new electro-mechanical product design effort (team of eight engineers including ME, EE, SW, and ID)- Managed resources and projects to achieve milestones on time with allocated resources and budget- Led team of three engineers to design and develop manufacturing processes for future closed system hazardous drug handling device to meet broader market needs while achieving cost goal and schedule- Worked with direct reports on development and performance improvement plans- Responsible for leading multi-discipline teams of engineers through the product development life cycle of pharmacy drug devices while working with marketing, customers, and other stake holders- Worked with multi-discipline teams to create product architecture, develop product requirements, and evaluate product risk - Led customer studies of new and existing products for feature exploration and continuous improvement- Responsible for solving system problems and directing engineers or technicians in root cause investigations along with corrective and preventative actions (includes both design and manufacturing)- Conducted and presented technical analysis and peer review of other’s analysis -
Sr. Mechanical EngineerConmed Corporation Feb 2005 - Jun 2008Largo (Tampa Bay), Fl, Us- Led contract design company in development of new electromechanical surgical product design - Responsible for Altrus Thermal Tissue Fusion hand piece engineering to meet product requirements- Directed engineers & technicians to maximize engineering output and accelerate time to market- Designed patented high force, close tolerance surgical systems for high volume manufacturing- Created innovative argon beam/electrosurgical dual mode disposable to reduce procedure cost and time- Tested and evaluated new products in pre-clinical tissue laboratories for performance and clinical effect- Collaborated with marketing, surgeons, nurses and other users to get product feedback - Mentored junior engineers and led/supervised CU senior design projects for multiple years
-
Sr. Mechanical EngineerCps Innovations (Acquired By Siemens Healthcare) Dec 2002 - Feb 2005Lead engineer that developed next generation Positron Emission Tomography (PET) scanner platform - Designed and released PET scanner which met FDA design control requirements- Conducted FEA and analytical studies to verify safety and other design standards are met- Designed scanner to be fabricated and assembled with low cost processes in ISO environment- Utilized other engineers to leverage myself and maximize company contribution- Generated potential PET scanner concepts with defined functionality and options- Developed project schedule for multi-phase product introduction- Communicated with cross functional groups to develop and write product specifications- Presented concepts and designs to upper level leadership team to gain consensusConceptualized design of dedicated neurological PET scanner (for Alzheimer’s and brain studies)- Complete system design concept developed for low cost doctor’s office use- Developed patentable germanium transmission source using radiation transparent materialsWorked on final development of previous whole body PET imaging scanner system- Improved manufacturability and reduced cost of radiation transmission source by 50%- Redesigned EMI compliant electronics enclosures for 20% cost reduction - Responsible for design, manufacturing, documentation, and V&V of mechanical systems -
Owner And Principal ConsultantAcumen Design Engineering, Llc Jan 1999 - Dec 2002- Engineered innovative product development solutions in biomedical, computer and consumer markets- Developed part and machine designs for various companies including Hewlett Packard Co., Agilent Technologies, Cytomation Inc, Ultimate Support and others- Designed automated system to increase sample analysis throughput and be used in the pharmaceutical drug discovery process (fluidics and electromechanical system development) - Developed sample input system from initial concept through manufacturing phase - Wrote software to control sample input system and improve performance- Designed, prototyped, and tested sheet metal parts for new robotic mass storage and backup system - Designed and conducted thermal experiments to determine optimal drive cooling design - Developed mechanical design to optimize electronics cabling, RFI, ESD and more- Worked with cross functional teams to develop new products (ME, EE, SW, and marketing)- Solved manufacturing problems through design and/or process changes- Directed contract engineers and technicians working on company projects
-
Development EngineerHewlett Packard Aug 1993 - Jan 1999• Designed automated scanner alignment system including hardware, electronics, and SW user interface• Developed motion control software and alignment algorithms for automated scanner aligner systems• Designed mechanical aspects of infrared sensors (plastic parts and electrical components) and implemented manufacturing processes• Interacted with electrical, firmware, and software teams to ensure overall sensor system functionality• Responsible for solving production problems and developing product cost reduction efforts• Installed, programmed, and improved yield of screw insertion robots by 50%
Steve Donnigan, Pe, Cpm, Msme Biomedical Engineering Skills
Steve Donnigan, Pe, Cpm, Msme Biomedical Engineering Education Details
-
Colorado State UniversityMechanical Engineering -
Colorado State UniversityMechanical / Biomedical Engineering
Frequently Asked Questions about Steve Donnigan, Pe, Cpm, Msme Biomedical Engineering
What company does Steve Donnigan, Pe, Cpm, Msme Biomedical Engineering work for?
Steve Donnigan, Pe, Cpm, Msme Biomedical Engineering works for A65 Consulting, Llc
What is Steve Donnigan, Pe, Cpm, Msme Biomedical Engineering's role at the current company?
Steve Donnigan, Pe, Cpm, Msme Biomedical Engineering's current role is I help medical device innovators bring their ideas to life by leveraging my engineering expertise and commitment to excellence, ensuring every project meets performance targets and satisfies customer needs..
What is Steve Donnigan, Pe, Cpm, Msme Biomedical Engineering's email address?
Steve Donnigan, Pe, Cpm, Msme Biomedical Engineering's email address is st****@****ter.com
What is Steve Donnigan, Pe, Cpm, Msme Biomedical Engineering's direct phone number?
Steve Donnigan, Pe, Cpm, Msme Biomedical Engineering's direct phone number is +130361*****
What schools did Steve Donnigan, Pe, Cpm, Msme Biomedical Engineering attend?
Steve Donnigan, Pe, Cpm, Msme Biomedical Engineering attended Colorado State University, Colorado State University.
What skills is Steve Donnigan, Pe, Cpm, Msme Biomedical Engineering known for?
Steve Donnigan, Pe, Cpm, Msme Biomedical Engineering has skills like Medical Devices, Design Control, Product Development, Design For Manufacturing, Cross Functional Team Leadership, Solidworks, Manufacturing, R&d, Validation, Engineering, Pro Engineer, Testing.
Free Chrome Extension
Find emails, phones & company data instantly
Aero Online
Your AI prospecting assistant
Select data to include:
0 records × $0.02 per record
Download 750 million emails and 100 million phone numbers
Access emails and phone numbers of over 750 million business users. Instantly download verified profiles using 20+ filters, including location, job title, company, function, and industry.
Start your free trial