Sr. Project Manger, Sr. Program Manager, Medical Device

MICHELLE LYMAN,

Framingham, MA ad7gkn@r.postjobfree.com 508-***-**** https://www.linkedin.com/in/michelle-dawn-lyman/ Senior Project Manager Senior Program Manager Medical Device Accomplished project management professional with a strong background in engineering research and development. Passionate about driving impactful healthcare innovations, evidenced by successfully managing diverse medical device multidisciplinary project teams from product concept through transfer. Experience spans a wide range of projects including sterile & non-sterile single-use products, complex imaging equipment, implantable devices, distribution/resale products, inhalation toxicology studies, nitric oxide systems, and biopharmaceuticals. Proven ability to facilitate effective cross-functional communication across stakeholders. Committed to continuous learning and integrating new skills, technologies, and methodologies. Clifton Strengths: Harmony Responsibility Consistency Analytical Input EXPERTISE

● Collaborative Problem-Solving

● Project Planning and Execution

● Critical Chain Project Management

Methodologies and Best Practices

● Risk Mitigation

● Medical Device Product Development

● Project Budgeting

● Team Leadership/Team Building

● Critical Thinking

● Stakeholder Management

● Vendor Selection and Management

● Change Management

● Written and Oral Communication

● Design Control

● Good Manufacturing Practices

● Electronic Document Management Systems

TECHNICAL EXPERTISE

● MS Project Smartsheet Jira Visio

● Microsoft Office 365 Word Excel Acrobat Sharepoint Teams

● Product Lifecycle Management Software (PLM): Arena Netsuite

● Quality Management System Software (QMS): Agile Windchill Orcanos

● Medical Device international standards and regulations (ISO-13485 for quality management, ISO-62366 for usability, ISO-60601 for safety, ISO-10993 for biological evaluation, ISO-62304 for software)

● 21 CFR Part 801 for medical device labeling

EXPERIENCE

Third Pole, Inc Waltham, MA

Startup developing Inhaled Nitric Oxide therapies for cardiopulmonary applications, in hospital and home use. Sr. Project Manager Apr 2020- Apr 2024

Led multidisciplinary project teams, comprised of systems engineering, mechanical, electrical, software, quality, regulatory, clinical, process development, manufacturing, operations, human factor engineering, and labeling, developing novel Class III medical devices resulting in treating 4 patients with advanced lung disease in an early feasibility IDE clinical study and completion of 2 inhalation toxicology animal studies that supported regulatory filings.

● Formulated and implemented detailed project schedules with multidisciplinary project teams, strategically assigned tasks and navigated unexpected technical challenges resulting in project completion to meet business goals.

● Identified and tracked project risk; incorporated mitigation strategies into project plans.

● Communicated project status and impacts to senior leadership on a regular basis.

● Compiled and communicated robust project lessons learned to apply best practices to future projects.

● Gained approval from project leadership for all phase gates including clinical study readiness review.

● Established long-term project strategy steering committee, influenced removal of an indication from the project scope to focus on the indication that better aligned with the overall regulatory strategy.

● Participated in a successful FDA ISO-13485 recertification audit.

● Selected and hired subject matter expert to lead technical implementation of Arena PLM software tool after playing a key role in defining PLM vendor requirements.

● Planned and coordinated 2 complex inhalation animal toxicology studies (4-week and 6-month) at a Canadian contract lab, coordinated proposals, agreements, purchase orders, and material logistics for a unique research device.

Hologic, Breast and Skeletal Health Division Marlborough, MA Global champion of women’s health through early detection and treatment. Sr. Project Manager Jul 2016-Apr 2020

Managed the launch of innovative Class I and II medical device products to the market, overseeing the entire product development lifecycle from concept to market introduction while ensuring compliance with design controls and regulatory standards.

● Directed a high-performance team to launch a Single-Use Breast Biopsy Site Marker in just 4.5 months expanding the interventional product portfolio.

● Stepped into a pivotal role mid-project and led a multidisciplinary project team through project scope changes that launched product enhancements to a Mini C-Arm extremities imaging system.

● Initiated and directed the early phases of a software feature enhancement and bug fixes project, laying the foundation for future development and setting strategic direction.

● Delivered a comprehensive analysis of the Dual Energy X-ray Densitometry project to the governance board, resulting in the strategic cancellation and reallocation of resources towards higher-margin initiatives.

● Developed and implemented a standardized project kick-off presentation template for project management office consistency.

Boston Scientific, Endoscopy Division Marlborough, MA Worldwide developer, manufacturer and marketer of less invasive medical devices Project Manager Oct 2006- Jul 2016

Managed multiple mid-to-large scale projects for Class I and II medical devices through the development process. encompassing internally and externally manufactured new products, distribution-only initiatives, sustaining efforts, and expanded indications for use.

● Devised an innovative and unique testing approach for MRI compatibility of the commercially available hemostatic clip, in collaboration with the project team, which circumvented a product redesign resulting in

$1.62M project spend savings and led to earning several internal company awards.

Knowledge Driven Product Development Leadership award

Gold level VIP award

Annual Recognize Excellence award

Quarterly Key Contributor Team award

● Assumed project leadership in the late stages of product development and spearheaded the execution of 3 critical product launches of the next generation biopsy forceps (Cautery, Pediatric and Pulmonary) for tissue collection within an ambitious 8-month timeline.

● Directed a global team of 50 in developing an esophageal stent line for palliative treatment of esophageal cancer, achieving over $12M in revenue in the first year, exceeding targets.

● Expanded the Endoscopy Division’s product portfolio by delivering a project involving distribution of a sourced finished medical device, endoscopic retrieval device for polyp and foreign body retrieval.

● Co-led Women’s Network mentoring program, fostering professional growth and development.

● 4-time winner of the annual Engineering Excellence award presented to employees who exceed performance expectations.

Additional experience:

● GE Healthcare Westborough, MA Sr. Project Engineer/Project Manager Division developing membrane separation products in lifesciences applications

● Confluent Surgical, Inc. (Tyco) Waltham, MA Sr. Project Engineer Startup company that developed in- situ polymerization of biomaterials for Adhesion Prevention & Surgical Sealants

● Focal, Inc. (Genzyme) Lexington, MA Project Engineer Startup company that developed synthetic surgical sealants

● Biopure Corp Cambridge, MA Engineer

Biopharmaceutical company that specialized in oxygen therapeutics (blood substitutes) for both human and veterinary use

● Massachusetts Institute of Technology Cambridge, MA Lab Technician Supported post-doctoral tissue engineering research in the chemical engineering department EDUCATION:

BS, Chemical Engineering, University of Massachusetts at Amherst CERTIFICATION:

Project Management Professional (ID #1519537)

AFFILIATION:

Project Management Institute, Central Mass Chapter member

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