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Project Manager (Device)

Compass Consulting

San Ramon, CA

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JOB DETAILS
SKILLS
Best Practices, Budgeting, Competitive Analysis/Strategy, Conference Management, Contract Manufacturing, Customer Acquisition, Data Analysis, FDA (Food and Drug Administration), Hardware Development, Hospital, ISO (International Organization for Standardization), Inventory Control System, Investor Relations, Lean Manufacturing, Maintain Compliance, Manufacturing, Marketing Plan, Marketing Strategy, Marketing/Promotional Messaging, Product Development, Product Lifecycle, Product Marketing, Product Positioning, Product Strategy, Product/Service Launch, Production Control, Project Design, Project/Program Management, Public/Media/Press/Analyst Relations, Regulations, Regulatory Compliance, Regulatory Requirements, Relocation Services, Risk, Risk Analysis, Risk Management, Sales, Software Development Lifecycle (SDLC), Standard Operating Procedures (SOP), Trend Analysis, Usability Engineering
LOCATION
San Ramon, CA
POSTED
30+ days ago

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 FDA’s 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 Company’s 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.

About the Company

C

Compass Consulting

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