Project Manager

MOBILion Systems

Philadelphia, PA, US
  • Job Type: Full-Time
  • Function: Engineering Prod Mgmt/Dev
  • Post Date: 04/09/2021
  • Website: mobilionsystems.com
  • Company Address: 4 Hillman Drive, Suite 130, Chadds Ford, PA, 19317

About MOBILion Systems

MOBILion’s technology makes it easy to separate, identify and analyze the most challenging molecules that other instruments fail to detect. Our higher resolution, faster analysis and simpler workflows reveal molecules that are most important in characterizing biologic therapeutics, discovering biomarkers, and improving the accuracy of diagnostic tests. We make today’s treatment’s safer and more effective, empower tomorrow’s disease prediction and diagnosis, and accelerate the development of new therapies.

Job Description

Project Managers are responsible for leading a cross functional team of internal and external resources from R&D, Marketing, Quality, and Order Fulfillment through the product development lifecycle from idea to commercial launch.

Responsibilities

  • Actively manage product development schedules’ weekly deliverables. Ensuring that the project team members adequately breakdown the project schedules high level deliverables into manageable work packages or engineering plans and track progress using project management techniques.
  • Create and manage project risk registers, ensuring that the team creates either contingency or mitigation plans that proactively allow the project to keep moving forward if a risk is realized.
  • Assist Software Development construct timelines that trace from customer requirements, through the entire development cycle build, and ensure that their major deliverables trace to the overall projects’ schedule.
  • Lead small multifunctional teams, many of which may be external resources, in the development of new scientific instrumentation products as well as in successful product extensions and improvements.
  • Assist in leading product development projects through a product development lifecycle and lead project checkpoint reviews.
  • Assist with maintaining the appropriate resource loading that is needed to maintain project deliverables, including budget and schedule.
  • Work closely with internal and external staff, customers, and resources to ensure that product requirements are clearly understood, defined and met, and that design control is documented in accordance with Company and regulatory requirements.
  • Assist with developing and maintaining Product Development Procedures, as well as project management plans for each project.
  • Assisting conducting post-mortem with team members and appropriate senior management on each phase during the program
  • Assist with creating and submitting weekly project status dashboards (project status, issues, potential issues, etc.) to internal management (and clients if applicable)
  • Ability to communicate and coordinate all aspects of project activities, between mechanical engineering, electrical engineering, application scientist, business, 3rd party vendors, quality, regulatory, testing, documentation, etc. to ensure all products are developed within cost targets and delivered on schedule

Required Qualifications

  • A Bachelor of Science Degree and a minimum of 5 years of experience in product development, diagnostics, and/or medical instrumentation and device development or its equivalent experience.
  • Solid project management experience to drive completion of projects and practical application of a design-controlled product development process.
  • Demonstrated ability to direct and manage resources, make decisions, solve problem, exercise good judgment & flexibility and maintain budgets and schedule.
  • Experience with resource and budget forecasting and resource gap analysis
  • Flexibility to perform and manage a wide range of activities and willingness to “wear many hats”
  • Ability to work within the United States
  • Willing to relocate to the Chadds Ford, PA region

Preferred Qualifications

  • PMP Certification
  • Familiarity in the design of complex medical/pharma capital or scientific equipment (i.e. Mass Spectrometers, Imaging Systems, Monitoring systems, etc.)
  • Familiarity with appropriate FDA, QSR, and ISO regulations: design controls, document controls, design verification and validation, hazard analysis techniques, regulatory approval methods, and overall medical device/pharma industry knowledge
  • Manage the design and development of complex electro-mechanical pharma, medical devices and equipment.
  • Experience with a variety of manufacturing processes, including injection molding of plastics, machining methods, electrical layouts, rapid prototyping techniques, sheet metal fabrication, etc.
  • Understanding of Human Centered Industrial Design & Usability research activities and their interface with engineering
  • Understanding of Mechanical engineering development process utilizing 3D CAD or related engineering software techniques
  • Understanding of electronics and software development
  • Understanding of Voice of the Customer and User Needs research activities and process
  • Experience with Six Sigma tools and techniques, i.e., DMAIC, 5s, VSM, QFD, etc.
If interested, please send a cover letter and resume

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Disclaimer: Local Candidates Only
This company does NOT accept candidates from outside recruiting firms. Agency contacts are not welcome.