Summary
Overview
Work History
Education
Skills
Additional Information
Work Availability
Timeline

Pamela M. Kabbes

San Jose,CA

Summary

Seasoned Engineering Manager offering 20+years of leading products from initial concept through full market launch; proven track record of on-time and on-budget project delivery; over 30 years of experience in medical device design, development, and manufacturing; diverse experience in a variety of devices from implantable devices to large capital equipment.


Product Development strategist that has managed multimillion dollar projects with teams as large as 50 engineers and managers; Leader of project teams with significant cross-functional and international coordination; Managed technical discussions to achieve collaborative solutions with all key stakeholders.


Seasoned Engineering Manager adept at seamlessly integrating project technical aspects and making information relatable to non-technical personnel. Clear communicator, decision maker and problem solver.


Organized and dependable candidate successful at managing multiple priorities with a positive attitude. Willingness to take on added responsibilities to meet team goals.

Overview

12
12
years of professional experience

Work History

Staff Engineering Program Manager

PROCEPT BioRobotics
11.2022 - Current


  • Led project teams across all phases of scoping, planning, executing and production for complex medical device projects
  • Prepared project dashboards and presented project status and updates to Senior Management
  • Focused teams on deliverables and ensured projects remained on schedule, adapting schedules as conditions or data dictates
  • Establishing pilot lines at a new location for the next generation product for both capital and disposable production

Engineering Program Manager

Oxford Resources International
10.2021 - 10.2022
  • Contract employee for Auris, Johnson and Johnson
  • Led team of engineers to purchase equipment to establish two additional production lines.

Senior Engineering Project Manager

RQM, EU MDR Remediation
04.2020 - 09.2021
  • Contract employee for Stryker Sports Medicine
  • Developed project plan to remediate 16 Technical Documents for EU MDR two years before due date
  • Coordinated work across all workstreams to create or gather the needed documentation
  • Reported the project’s plan and status to senior management at Stryker.

Senior Engineering Project Manager

Oxford Resources International
08.2019 - 03.2020
  • Contract employee for Zoetis
  • Tracked capital spending for 15+ projects totalling over $5MM
  • Worked with engineers on 4 major capital projects to implement new robotic processing equipment
  • Created status on capital projects to senior leadership.

Senior Engineering Project Manager

Maetrics
03.2018 - 08.2019
  • MDR Implementation at Abbott
  • Contract employee for Abbott Medical Device Division
  • Implemented procedure changes for EU MDR compliance at 3 Business units within Abbott
  • Conducted weekly core team meetings to ensure all teams are meeting established milestone
  • Reported project status weekly to senior leadership.

Clinical Operations Manager

Zoll Medical
01.2017 - 02.2018
  • Temperature Mng System
  • 250 employees at Santa Clara site
  • Managed a team of 8 associate in clinical operations
  • Implemented processes to track the progress of 3 international clinical trials
  • Presented trial status following a corporate template.

Program Engineering Manager

Senseonics
03.2016 - 01.2017
  • Continuous Glucose Monitor
  • 100 employees
  • Led a project cross functional team and an external design team on the development and launch of a continuous glucose monitor to ensure that they remain on schedule and within budget
  • Presented the project status to the management team and the led the discussion on the strategic implementation of changes to the product.

Sr. Engineering Program Manager

Stryker Spine
06.2015 - 02.2016
  • Led an international team for the revision of labelling on over 10,000 products for addressing a tax requirement
  • Travelled to the manufacturing plant in Switzerland to coordinate with the manufacturing team on the implementation of the revised labelling.

Sr. Engineering Program Manager

Lighthouse Imaging
01.2015 - 06.2015
  • Optical System
  • 20 employees
  • Led a project team of 4 engineers through development of an optics system for a client
  • Communicated with the client on project status and needs
  • Created quotes for an additional 4 projects.

Sr. Engineering Program Manager

MedVenture Technologies
01.2012 - 11.2014
  • Catheter Projects
  • 250 employees
  • Led project teams of 1 - 6 engineers through development for three projects in R&D in parallel
  • Directed teams through root cause analysis and implementation of corrective actions
  • Created proposals for new product development projects
  • Presented project status to senior management and clients during monthly updates.

Education

Black Belt in LEAN - LEAN

LEAN, San Jose, CA
08.2017

Certification for Project Management Professional (PMP Certified) -

Project Management Professionals, San Jose, CA
08.2013

Bachelor of Science - Mechanical Engineering

Purdue University, West Lafayette, IN
12.1986

Skills

  • Lead cross-functional, worldwide teams through projects and product development
  • Extensive experience with budget and scheduling Project Management tools
  • Developed creative solutions to complex problems
  • Black Belt Certification
  • PMP Certification
  • Proficient in MS Office tools, especially MS Project
  • Quality and Risk Reduction focus in leading New Product Development
  • Project Strategy
  • Change Management Process

Additional Information

  • CER 820 & ISO 13485 and EUMDR Knowledge base
  • Awarded two patents for unique designs for disposable laparoscopic access port products develop while working at Ethicon EndoSurgery. Awarded two additional patents for disposable components for an Angiogram injector while working at Liebel-Flarsheim.
  • Authored the technical section of a regulatory filing for a 510k submission.

Work Availability

monday
tuesday
wednesday
thursday
friday
saturday
sunday
morning
afternoon
evening
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Timeline

Staff Engineering Program Manager - PROCEPT BioRobotics
11.2022 - Current
Engineering Program Manager - Oxford Resources International
10.2021 - 10.2022
Senior Engineering Project Manager - RQM, EU MDR Remediation
04.2020 - 09.2021
Senior Engineering Project Manager - Oxford Resources International
08.2019 - 03.2020
Senior Engineering Project Manager - Maetrics
03.2018 - 08.2019
Clinical Operations Manager - Zoll Medical
01.2017 - 02.2018
Program Engineering Manager - Senseonics
03.2016 - 01.2017
Sr. Engineering Program Manager - Stryker Spine
06.2015 - 02.2016
Sr. Engineering Program Manager - Lighthouse Imaging
01.2015 - 06.2015
Sr. Engineering Program Manager - MedVenture Technologies
01.2012 - 11.2014
LEAN - Black Belt in LEAN, LEAN
Project Management Professionals - Certification for Project Management Professional (PMP Certified),
Purdue University - Bachelor of Science, Mechanical Engineering

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Pamela M. Kabbes