Position: Project Manager

Reports to: Director of Project Management

Position Location: Company HQ in Suburban Philadelphia, PA

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 to post-launch support.

Responsibilities:

  • Responsible for developing project plans for each project. Assist with developing and maintaining Product Development Procedures
  • Responsible for following and executing projects as per the guidelines provided by PMO
  • Actively contribute towards improving Project Management methodologies and processes
  • 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.
  • Assist with conducting post-mortem with team members and appropriate senior management on each phase during the project
  • Serve as a primary point of contact for all project stakeholders. Responsible to create and communicate on a weekly basis, the project status (project status report, risks, issues, on-going actions 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
  • Ability to navigate within complex topics – understand the big picture while also being able to dive into the details

Required Skills & 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.
  • Ability to work within the United States
  • Willing to relocate to the Chadds Ford, PA region
  • 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, resolve conflicts, 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”

Preferred Skills & 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.

Cultural, Behavioral and General Characteristics

  • Outstanding people skills; confident, great communicator, honest, and sincere
  • Must be a dynamic personality and willing to work within a collaborative team environment
  • Energetic, proactive self-starter who enjoys challenges and variety
  • Integrity
  • Independent and self-starter
  • Work standards/high work ethic – initiative and drive
  • Innovativeness & creativity
  • Self-sufficient, self-driven, self-motivated (work with minimal supervision): figure it out
  • Adaptability
  • Ability to think through complex issues and solve problems
  • Desire to share information and support a transparent culture
  • Technical translation