Our client is a mobility solutions provider with a solution that integrates evidence-based best practices in high-risk Hospital Acquired Pressure Injury (HAPI), patient falls and Safe Patient Handling and Mobility (SPHM) activities.
About the Role:
This position will drive the product life cycle with quality and regulatory compliance needs across
the enterprise.
Duties and Responsibilities:
Lead lean manufacturing project for production and inventory control system implementation.
Risk assessment of production and development projects (Design and Process FMEAS, Product Risk Assessments, Quality Plans, Risk Management Plans/Reports) v2.
Act as Management Representative ensuring compliance with essential domestic and international regulation requirements and/or programs such as FDAs Quality system Regulation and ISO standards.
Partner closely with technical and regulatory leaders in ensuring that product requirements, usability and other key components of the regulated Design History File (DHF) are appropriately captured and updated per Companys Standard Operating Procedures (SOPs). Represent this expertise to relevant regulatory bodies during any product audits.
Drive development of product positioning, impactful messaging that resonates with both customers and sales teams, field assets to enable conversions, conference presence and planning to maximize exposure, Public Relations and Investor Relations initiatives.
Guide all stages of the Software and hardware development lifecycle by serving as the Product/Portfolio Leader; drive successful trade-offs affecting cost, time to market, user functionality and adoption. Be recognized in the organization as the Subject Matter Expert in their solution space.
Build effective relationships with contract manufacturers to meet delivery and budgetary goals.
Lead service/product line in existing and into new market opportunities.
Write and present marketing plans for product launches.
Understand competitive products, strategies and their marketing, and track sales data and analyze trends for use by sales, marketing manufacturing planning.
Numbers & Facts
Location
San Ramon, CA
Skills
Best Practicesunmatched
Budgetingunmatched
Competitive Analysis/Strategyunmatched
Conference Managementunmatched
Contract Manufacturingunmatched
Customer Acquisitionunmatched
Data Analysisunmatched
FDA (Food and Drug Administration)unmatched
Hardware Developmentunmatched
Hospitalunmatched
ISO (International Organization for Standardization)unmatched
Inventory Control Systemunmatched
Investor Relationsunmatched
Lean Manufacturingunmatched
Maintain Complianceunmatched
Manufacturingunmatched
Marketing Planunmatched
Marketing Strategyunmatched
Marketing/Promotional Messagingunmatched
Product Developmentunmatched
Product Lifecycleunmatched
Product Marketingunmatched
Product Positioningunmatched
Product Strategyunmatched
Product/Service Launchunmatched
Production Controlunmatched
Project Designunmatched
Project/Program Managementunmatched
Public/Media/Press/Analyst Relationsunmatched
Regulationsunmatched
Regulatory Complianceunmatched
Regulatory Requirementsunmatched
Relocation Servicesunmatched
Riskunmatched
Risk Analysisunmatched
Risk Managementunmatched
Salesunmatched
Software Development Lifecycle (SDLC)unmatched
Standard Operating Procedures (SOP)unmatched
Trend Analysisunmatched
Usability Engineeringunmatched
🎯
Be found by employers
5,500+ employers search our resume database daily. Add yours to get found by recruiters looking for candidates like you.
Level up your application
Professional resume templates
Browse dozens of recruiter approved resume templates, layouts and formats. Choose your favorite and make it your own in minutes.