Medical Device Product Development Expert Consultant

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Summary

This Medical Device Product Development Expert is an experienced executive leader with a demonstrated history of working in the medical device industry leading Innovation, Operations and Business Unit General Management. This expert consultant is skilled in Medical Devices, Supply Chain, Manufacturing, Product Marketing, Business Unit Management, P&L, Product Innovation, Engineering, and New Product Development. His enterprise size ranges from early stage thru Fortune 500. He is a strong engineering professional with a BS focused in Electrical Engineering Technology from University of Pittsburgh.

Highlights

  •  In a turnaround assignment, successfully managed and grew a wearable product BU with ~$250M with P&L responsibility.
  • Had accountability for Product and Portfolio Growth Strategy, Voice of Customer, Business Modelling and Lean Start-up, Road mapping and Cost Down/Procurement strategy. Trained as Innovation facilitator through IDNA.
  • Over 14 years’ operational experience with high revenue growth – including leading supply chain, multi-plant manufacturing and service operations across multiple sites and geographies.  
  • Over 20 years of experience in leading research, new product development, PMO and sustainment programs and teams for medical device Hardware, Wearable, and Software products.  
  • Led several programs, starting from strategy development through transformation. Developed plans for business growth/turnaround, portfolio refresh, org. restructuring and core capability assessment.  
  • Highly experienced in performance management and business process improvement. Trained as Lean Executive Leader with a track record of improving delivery, quality and productivity.  
  • Large (+2000 employee), global, multi-site leadership experience. Proven track record as coach, mentor and change agent for cultural excellence and employee engagement.  
  • Led one acquisition from start thru closure. Participated in many acquisitions from due diligence thru post-merger integration.  
  • Extensive background in Quality Audit and Reliability Engineering. Led several compliance initiatives including co-leader for EUMDR and FDA compliance remediation.  
  • Over 30 years in Medical Device development and manufacturing, mostly in Sleep and Respiratory products

Relevant Accomplishments

  • Led ~200+ Engineers across global geographies in New Product Development for Sleep and Respiratory hardware, software and wearable products  
  • Led program to restructure global Research & Development organization, driving ~$6M productivity savings  
  • Launched Emergency Use Ventilator during COVID crisis, earning CEO award  
  • Co-chaired EUMDR program and led sustainable design  
  • Restructured, created and led central engineering (~180 FTE) and innovation function to support multiple R&D teams  
  • Created Innovation Start Up program called QUEST to enable intrapreneurs to bring ideas forward inside the business  
  • Deployed global R&D best practice processes using Philips Excellence Framework, achieving ~18M productivity savings over 3 years 
  • Led device and wearable NPD for Sleep category. Several products earned prestigious Red  Dot design award as well as a CEO Innovation and Quality Award.  
  • Led formation and scaling of business unit for development of CPAP Masks, consisting of ~100 employees for Product Management, Research & Development, PMO, Operations  
  • Business Unit size was ~$250M with P&L responsibility  
  • Results included significant share gains, launch of 7 new masks, defect reduction of 400% and design awards  
  • Created and led Strategy and Transformation program to turn around business, refresh product portfolio, and build innovation core competency for category  
  • Made culture and employee engagement a priority, deploying specific strategy called “3E,” transforming to high performing culture and team. 
  • Led acquisition of MedSage Technologies to extend category into service solutions.  

Roles

  • Senior Director, Product Development (2019-2022) 
  • Senior Director, Innovation & Engineering (2014-2019)  
  • Gus Gear (Oct 2022-Present) – Part time  
  • Senior Director, NPD Sleep Apnea (2012-2014)  
  • Vice President and General Manager Patient Interface Business Unit (2007-2012) 
  • ERP SAP Consultant (1998-2000)  
  • Technical Service Manager (1994-1998)  
  • Quality Engineer – (1993-1994)  
  • Electrical Project Engineer (1984-1990)  

Request Expert / Similar Expert

Click “request expert” for a free initial screening call with this expert or a similar expert regarding your expert consulting needs

To apply for this job email your details to haleymmagnani@gmail.com