Summary
Overview
Work History
Education
Skills
Certification
Timeline
Generic

Darcy Sheerin

Bridgewater,MA

Summary

Lifesciences seasoned professional with experience in hospital clinical care(cath lab and vascular lab) and medical device start ups. Over 25 years’ experience in the medical device industry specializing in enhancing products, conceptualization of new products, prototyping and testing, and evaluations of revisions before commercializing and delivering a breakthrough finished product. Focusing on assuring regulatory compliance to domestic and international regulations, standards and guidelines for the medical device industry. Adept in collaborative problem solving, risk management and creative solutions. Passionate about bringing changes in businesses. Successful in meeting new challenges and finding effective solutions.

Overview

28
28
years of professional experience
1
1
Certification

Work History

Sr Consultant for Regulatory and Quality Solutions

Dassault Systèmes
10.2013 - Current
  • Increased client satisfaction by providing tailored consulting services and effective problem-solving strategies.
  • Delivered high-quality solutions for clients through comprehensive research and analysis of industry trends.
  • Assisted in business development efforts, securing new contracts and expanding the company''s client base.
  • Developed innovative strategies to address complex business challenges, resulting in increased profitability for clients.
  • Provided expert guidance on change management initiatives, leading to successful organizational transformations.
  • Managed cross-functional teams to ensure timely delivery of high-quality solutions for various projects.
  • Collaborated with internal teams to develop customized solutions that addressed unique client needs.
  • Facilitated workshops with clients to identify pain points, establish goals, and define actionable steps towards achieving desired outcomes.
  • Leveraged extensive industry knowledge to provide valuable insights into emerging trends impacting client businesses.
  • Exceeded customer requirements with accurate and deliverable solutions.
  • Prepared presentations to explain revisions, enhancements and process improvements of organization's systems and programs.
  • Enhanced team performance by implementing training programs and fostering a collaborative work environment.
  • Medical Device Industry R&D Evangelist

Product Clinical and Training Manager

Corindus Inc.
10.2012 - 09.2013
  • Enhanced employee and customers performance by designing and implementing comprehensive training programs.
  • Increased overall productivity by conducting regular skills gap analyses and addressing identified needs with targeted training interventions.
  • Reduced study deviations by closely adhering to clinical trial protocols and communicating effectively with the research team.
  • Collaborated with multidisciplinary teams for optimal patient care and accurate data collection in clinical trials.
  • Streamlined data collection processes by maintaining organized records of patient information, ensuring accuracy and efficiency in reporting.
  • Ensured proper handling and storage of investigational products, maintaining compliance with regulatory standards.
  • Supported ongoing training initiatives by conducting continuing education seminars
  • Increased participant retention rates through proactive communication, creating a positive experience for patients throughout the trial process.
  • Promoted patient safety by promptly identifying, reporting, and managing any adverse events or side effects experienced during clinical trials.
  • Mitigated risks associated with clinical trials by continually assessing patients for eligibility criteria changes or contraindications to participation.
  • Maximized protocol adherence by collaborating with clinical trial coordinators on schedule adjustments, avoiding conflicts that could affect participation or data quality.
  • Expedited IRB approval process through careful preparation and submission of required documentation in a timely manner.
  • Played a key role in troubleshooting any issues arising during clinical trials, collaborating with the research team to develop appropriate solutions.
  • Participated in quality improvement
  • Demonstrated knowledge of technical procedures and proper equipment use.
  • Maintained patient confidentiality by protecting unauthorized access to personal information.
  • Created educational materials for staff and patients.
  • Develop & manage the global preceptor and animal lab training program
  • Establish criteria, in collaboration with sales, clinical/medical affairs, marketing and legal/corporate compliance for new product/product improvements or clinical uses.
  • Responsible for keeping abreast of industry standards and trends as related to responsibilities, and communicates information to the organization.
  • Work with Regulatory to design and develop protocols for new indications
  • Work with sites on Phase 1 and Phase 2 protocols

Product Manager/ Global Marketing Manager (dual responsibility)(09/10-10/12)

  • Responsible for taking CorPath 200 from concept to clinical to market
  • Coordinate marketing materials, booth, housing, and speakers for all trade shows
  • Design and conduct training programs and best practice tools for physicians, employees, and hospitals.
  • Participate in design and implementing clinical trials.
  • Worked on FDA and regulatory submissions
  • Worked with IRBs and clinical coordinators at clinical sites
  • Conducted market research and product opportunity assessment, strategy formulation and valuation for new product developed in-house and potential acquisitions.
  • Regularly measure market perception of our total value offering to identify strengths and gaps, and provide actionable recommendations into the division’s strategic business plans
  • Provide guidance on the development and maintenance of packaging and labeling.
  • Created and printed all instructions for use manuals
  • Participated in developing reliability testing
  • Developed and implemented Biohazards room and training
  • Set pricing of products according to cost and market.
  • Develop and maintain strong relationships with key customers, both internal and external.

Global Product Marketing Manager

NMT Medical, Inc.
09.2006 - 09.2010
  • Increased global product visibility by developing and implementing strategic marketing plans.
  • Enhanced product awareness through the creation of compelling promotional materials and campaigns.
  • Managed cross-functional teams to ensure successful product launches, achieving company objectives.
  • Collaborated with sales teams to create effective sales tools, driving revenue growth in key markets.
  • Developed comprehensive go-to-market strategies for new product releases, ensuring timely execution and positive results.
  • Established strong relationships with industry influencers to enhance brand credibility and amplify messaging.
  • Coordinated international trade shows and events, showcasing products and generating leads for business development purposes.
  • Leveraged digital marketing channels to increase online presence, driving website traffic and lead generation efforts.
  • Implemented data-driven decisions to fine-tune marketing strategies, resulting in improved campaign performance metrics.
  • Conducted regular reviews of marketing spend, optimizing budgets for maximum return on investment across multiple channels.
  • Streamlined communication between departments through the implementation of efficient systems for information sharing.
  • Spearheaded thought leadership initiatives, positioning the company as an expert resource within its industry.
  • Developed training materials to educate both internal teams and partners on product offerings, features, benefits.
  • And positioning.
  • Collaborated with marketing department to define positioning and messaging and plan market launch, public relations and lead generation campaigns.
  • Drove marketing initiatives to increase product visibility and market performance.
  • Conceptualized and designed abstract ideas, built plans and delivered details to CMO.
  • Led staff and external agencies to develop products and promotions, analyze sales, manage trade shows, purchase media, provide creative services and conduct PR.
  • Contributed to planning and production of industry events, advertising, direct mail, telemarketing and sales collaterals.
  • Possessed expert knowledge of competitive and third party products and translated knowledge into business strategy.
  • Created product positioning and messaging to differentiate products in market and expand visibility.
  • Served as focal point for all customer input and market intelligence for product improvements.
  • Offered pricing and feature recommendations to management and cross-functional teams.
  • Boosted sales performance by conducting thorough market research and competitor analysis.
  • Optimized product positioning with targeted messaging for various customer segments.
  • Reported directly to President/CEO with main responsibility of the day to day core product management strategy and driving implementation of key marketing plans and initiatives for the company's growing domestic and international market segments
  • Key decision maker in new business development opportunities as well as key member of new product design teams. Worked directly with CEO on competitive analysis and assessment of new business opportunities
  • Managed complete product development cycles from initial market research, market opportunity recommendations and product development to commercialization of new products and market exit plans for old products

Territory Manager - Sales

Edwards Lifesciences
07.2004 - 12.2005
  • Expanded territory coverage by strategically identifying and targeting high-potential accounts.
  • Improved customer satisfaction and retention through frequent visits, timely response to inquiries, and effective problem resolution.
  • Developed strong relationships with key decision-makers, fostering trust and loyalty in the assigned territory.
  • Implemented successful sales strategies to drive revenue growth and exceed quarterly quotas consistently.
  • Top in sales training class - finished Q1 and Q2 at 100% to plan
  • Assisted with clinical trial enrollment and follow up

Territory Sales Manager, New England

Vasomedical, Inc
12.2003 - 07.2004
  • Increased sales revenue by developing and implementing strategic territory plans.
  • Established strong relationships with key clients, boosting customer retention rates.
  • Collaborated with marketing department to create promotional materials that drove brand awareness in the territory.
  • Maintained a deep understanding of industry trends, enabling informed decisions on sales strategies and product offerings.
  • Conducted regular product training sessions
  • Developed customized solutions based on client needs, resulting in increased customer satisfaction and loyalty.

Territory Manager, New England

Abbott Vascular Devices
10.1998 - 11.2003
  • Expanded territory coverage by strategically identifying and targeting high-potential accounts.
  • Improved customer satisfaction and retention through frequent visits, timely response to inquiries, and effective problem resolution.
  • Developed strong relationships with key decision-makers, fostering trust and loyalty in the assigned territory.
  • Implemented successful sales strategies to drive revenue growth and exceed quarterly quotas consistently.
  • Successfully launched several new products including four generations of Perclose devices, three families of the Biodivysio stent and a Chito-seal Hemostatic Patch
  • Ranked #1 in sales stent growth in the country between Jan and July 2002

Cardiac Catheterization Technologist Technical Dir

New England Medical Hospital
01.1996 - 10.1998
  • Cardiac Cath procedures
  • Pt care

Education

Bachelor of Science - Physical Education, Exercise Physiology

Bridgewater State University
Bridgewater, MA
05.1992

Skills

  • Consulting
  • Software Management
  • Teamwork Mindset
  • Lean Six Sigma
  • Cross-functional Collaboration
  • Marketing Strategy
  • Market Research
  • Digital Transformation
  • Regulatory Compliance
  • Product Development
  • Training and Development
  • Change Management
  • Agile Methodologies
  • Product Life Cycle Management
  • Go-to-Market Strategies
  • Configuration Management
  • Best Practices Implementation
  • Requirements Gathering
  • Continuous Improvement
  • Market Penetration
  • Processes and Procedures
  • Product Roadmapping

Certification

· Product Manager Course (Steven Haines)

· Dale Carnegie courses

· Adobe Creative Suite courses

· SPIN Selling

· Consultative Selling Training

Clinical

· ACLS Certification

· Advanced Lifesaving Certification

· First Aid / CPR Certification

· Basic Lifesaving certification

· Mass. Assoc. of Cardiovascular and Pulmonary Rehabilitation

Timeline

Sr Consultant for Regulatory and Quality Solutions

Dassault Systèmes
10.2013 - Current

Product Clinical and Training Manager

Corindus Inc.
10.2012 - 09.2013

Global Product Marketing Manager

NMT Medical, Inc.
09.2006 - 09.2010

Territory Manager - Sales

Edwards Lifesciences
07.2004 - 12.2005

Territory Sales Manager, New England

Vasomedical, Inc
12.2003 - 07.2004

Territory Manager, New England

Abbott Vascular Devices
10.1998 - 11.2003

Cardiac Catheterization Technologist Technical Dir

New England Medical Hospital
01.1996 - 10.1998

Bachelor of Science - Physical Education, Exercise Physiology

Bridgewater State University
Darcy Sheerin