Josh Stegmeyer, PMP

*** * ***** ******

Marquette, MI 49855

(H) 847-***-****

adck9s@r.postjobfree.com

Career Summary

Seasoned veteran in the Medical Device and Pharmaceutical industries, currently applying skills and talents in the Financial Sector. Leads cradle-to-grave new product development projects in Research and Development and led short-term client-facing projects involving nearly every facet and department of the hospital. Experience in medium size firms through Fortune 500. Successful in the global arena, having managed multi-national virtual teams and launched products around the world.

Education

Michigan Technological University Graduated 2005

BSE, Biomedical Engineering

Professional Certifications

PMI® PMP, 2009 – Present

NMLS, 2019 – Present

Professional Skills

Cross-functional team leadership – 8 yrs

Teams of 8 or more, PhD/MD/MBA experience level

Communication – 13 yrs

Executive level through individual contributor, written/oral/presentation

Project Management – 13 yrs

Client-facing and internal

Client Management – 5 yrs

As high as $44M per client

Coaching/professional development – 6 yrs

Goal setting, training, performance review

Product Launch – 6 yrs

US, Canada, EU, Asia, Africa, Latin America

Budget Management – 6 yrs

FY/FQ Forecasting, tracking, Internal and External, 3% accuracy, up to $24M per year

Clinical Trials – 5 yrs

Protocol Development, budgeting, execution, reporting, EU/US/AUS

Project Planning – 13 Yrs

Requirements gathering, integrated planning, resource allocation, budgeting

Technical Skills

Risk Management – 6 yrs

xFMEA, ISO 14971, 21 cfr 820

Design and Product Requirements – 6 yrs

Requirements refinement, Quality by Design, 21 cfr. 820, ISO 13485

Verification and Validation – 6yrs

Writing/executing protocols, review/approve reports, design of experiments

Design/Technology Transfer – 6 yrs

Injection Moldable, Chemical Products, Supply Chain Development

Process Improvement – 8 yrs

Value improvement, waste reduction, capacity improvement

MS Project – 13 Yrs

Project planning and budgeting, tracking

Medical Devices – 13 yrs

Class I through Class III, electromechanical, disposable, implantable

Pharmaceuticals – 6yrs

NDA Injectable, ANDA Oral, OTC Oral

Biologics – 4 yrs

Blood Products, Human Tissue, Xenograph

Financial Software – 6 yrs

Cognos, DNA, Excel

CRM Software – 5 yrs

Salesforce, Access

MS Office – 20 yrs

Word, Excel, Outlook, OneNote, SharePoint

Experience

Flagstar Bank, Marquette, MI June 2019 – March 2020 Relationship Banker

Business development with perspective businesses and consumers. Escalation resource for tellers and financial service representatives. Provide basic financial advice to current customers.

Boreal Aviation, Gwinn, MI December 2018 – June 2019 Metrology and Quality Assurance

Performed calibration testing and repairs on a large range of mechanical and electrical equipment. Provided QA approval on testing performed, confirmed compliance with relevant ISO and NIST standards. Assisted in the redevelopment of the Quality Management System to align with ISO requirements.

RTI Surgical, Marquette MI March 2018 – October 2018 Senior Project Manager, R&D

Represented the PMO on the International Franchise leadership team. Oversaw over a dozen development and new product introduction projects spanning 6 continents, including Class I through III Medical Devices, Xenographic, and Human Tissue products.

●Wrote new policy and improvements to RTI’s Market Expansion process; commissioned and oversaw new operational team.

●Personally led two high-priority, high-risk remediation and NPI projects related to the MDR transition in Europe.

●Wrote and provided training to rest of PMO.

●Served as coaching and escalation resourced to less experienced PMs.

Baxter Healthcare, Round Lake IL 2014 – 2018 Project Manager, R&D

Managed New Product Development projects for Baxter’s Pharmaceutical and Biologics portfolios, as well as oversaw Phase III clinical trials. Products ranged from New Drug Application infusion to Class III implantables to Biologic License Applications. Projects were cradle-to-grave, spanning from ideation through launch. Specialized in projects that are high-risk and high visibility, requiring regular reporting to Sr. Director and VP level.

●Launched new class II medical device in US, Europe, Latin America, and Australia.

●Project spend consistently +/- 3% of established budget.

●Over 95% of milestones met on or before their date.

●The average annual budget was $10MM apiece, with over $70MM Net Present Value in either loss avoidance or new profit.

●Provided assistance in generation of new documentation and policies for group, including a new project risk management policy and accompanying tools.

Sunstar Americas, Chicago IL 2012 – 2014 Project Engineer / Project Manager

Managed projects pertaining to research, design, and commercialization of new products, as well as provided key engineering support for those projects. Specialized in the most complex products within the company including: implantable bioresorbable materials, prescription drugs, OTC drugs, and chemical devices. Directly managed many aspects of development projects including requirements generation and analysis, verification testing, design controls, and design transfer.

●Within one year of employment, launched a successful international OTC drug product. This product sold over $2 million within the first year, making it the company’s highest grossing product.

●Projects were responsible for over $7 million dollars a year in new revenue or costs saved.

●Assisted in the development of documentation for a newly adopted phase-gate system.

CareFusion - Alaris Products, Chicago IL (Remote) 2007 – 2012

Sr. Project Manager 2010 - 2012

Ensured the faithful and timely execution of contracts pertaining to the implementation of the Alaris® Infusion System in hospital settings. Successful implementation required effective leadership of widely cross-functional teams including nurses, pharmacists, engineers, and executives. Functional project teams consisted of both company and customer personnel.

Field Support Engineer (Technical Project Manager) 2007 - 2010

Managed the planning and implementation of technical projects concerning the installation and upgrade of Alaris® Infusion Pumps. Technical projects included FDA audited check-in of systems, testing of hospital networks, and primary training of hospital personnel. Projects lasted an average of 1-2 weeks on-site at each hospital, and required the training and management of as many as 10 employees at each site.

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