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Company: ProArch Consulting Services
Location: Fremont
Posted on: April 10, 2021

Job Description:

Company Description:We are a leading manufacturer and supplier of flow cytometry products and services. Our compact, affordable instruments and wide-ranging support offerings are used by researchers and clinicians all over the world.Job Location: Fremont, CaliforniaMAJOR DUTIES AND RESPONSIBILITIES:The primary responsibility for the Project Manager is to lead Our Product Development or Product Improvement projects from Concept to Commercialization meeting the Project Scope, Quality, Cost, and Timing Objectives.Lead Project team to define and manage the following* Project and product scope* Project tasks required to complete deliverables* Project resources necessary to complete tasks in the desired time frame* Project schedule necessary for each phase of the project* Project and Product Risks associated with delivery of a quality product on time and on budget* Project budget (i.e. resource, material, external agreements, royalties)* Guiding the Technical team to identify objectives, address technical issues, make decisions, and create technical solutionsThe Project Manager is responsible for actively working cross-functionally to maintain engagement and focus on the project effort. Working with Sales and Marketing to develop the project Business Case and ensuring Customer Requirements and Product Design are in alignment to meet the target market and revenue forecast. Leading and Guiding the R&D development effort to meet defined project deliverables and milestones. Actively assess, anticipate and manage risks and issues with attention to detail. Create and execute strategies to address issues and risks to keep the project on track. Guides the concept to prototype to pilot to production engagement with R&D, NPI, Supply Chain, and Manufacturing to ensure material flow, supplier qualification, material cost, and Design Transfer to Manufacturing is completed. Manages adherence to Design Control processes per company RUO and Medical Device procedures. Organize and lead Design and Phase Reviews. Keep the Portfolio Review Board aware of Project status and any issues or risks that would affect the ability to deliver a quality product on time and on budget.EDUCATION REQUIREMENTS: Bachelor's Degree in Chemistry, Biology, or Biochemistry is required. Professional certification is preferred (i.e, PMP)EXPERIENCE QUALIFICATIONS:* At least 3 years of experience in leading the development, implementation, or commercialization of Flow Cytometry Reagents or other chemical analysis consumables and the associated software platforms supporting Life Science, Pharmaceutical, Diagnostic, or Medical Device industries. * Demonstrated experience creating chemical consumable development process and product workflows and associated software use cases. * Experience with Project budget creation, revenue forecasting, resource allocation, and project scheduling tools is required (i.e. JIRA, Confluence, MSProject, SmartSheet). * Experience using the Windows OS, MSOffice Applications, Engineering Change Order Systems, Design History Files, and the creation of Procedures and Reports.KEY SKILLS AND COMPETENCIES:* Demonstrated strong communication and presentation skills working with teams and with leadership. * Demonstrated ability to motivate and manage exempt and non-exempt cross-functional personnel. * Self-directed and resourceful having a mature ability to deal with conflict and drive resolution. * Demonstrated ability and knowledge to work across organizational functions to influence and drive the project effort with a sense of urgency. * Skill with identifying, clarifying, and reducing ambiguity for projects and products. * Work well under pressure and can maintain flexibility when addressing challenges.* Skilled with analyzing tradeoffs between product features, customer needs, manufacturability, serviceability, and cost. * Awareness of US and International regulations and standards that apply to the in vitro diagnostic and medical device industry, including FDA Quality Systems Regulations, CFR 820, ISO 13485 & 9001 & 14971. * Demonstrated verbal and written communication skills. Problem-solving, analytical, creativity, and critical thinking skills.

Keywords: ProArch Consulting Services, Fremont , PROJECT MANAGER (REAGENTS), Executive , Fremont, California

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