Project Manager, Medical Device / Consumer Health Industry

  • Full-time

Company Description

Simbex is an experienced medical device and consumer health product design and development partner that excels in transforming complex ideas into game-changing commercial solutions.

Job Description

The Project Manager is responsible for the coordination, implementation, and execution of medical device/consumer health projects in order to deliver high quality results while managing cross-disciplinary resources, schedule and budget.  At Simbex, Project Managers may be responsible for many smaller projects that are part of a larger set of deliverables or may be responsible for individual projects with their own schedules and deliverables.  The Project Manager will be responsible for the overall direction, coordination, implementation, execution, control and completion of specific projects ensuring consistency with company strategy, commitments, and goals.

Essential Functions

  • Manage a portfolio of clients and facilitate execution of their projects from initiation to closure;
  • Provide project management domain expertise, mentorship, leadership, and positive motivation to  cross-functional teams;
  • Work directly with clients to develop and update project plans, including outlining goals, budget, timing, and required resources;
  • Establish clear expectations and deliverables that align with client needs and ensure that the team is working towards these goals;
  • Prepare and present project updates using Microsoft PowerPoint and similar tools to project stakeholders and executive management;
  • Work with clients and staff to document, manage and mitigate project risks throughout the project cycle;
  • Work with cross-functional team leaders to identify and allocate resources;
  • Take initiative and proactively communicate with and amongst the team to facilitate collaboration and transparency;
  • Lead and integrate cross-functional teams and manage deliverables in a matrix organization;
  • Review deliverables prepared by team before passing to client;
  • Ensures internal project documents are complete, current, and stored according to Simbex’ Quality Management System;
  • Contribute on technical approach, design and process by helping to reveal trade-offs to help make rational decisions;
  • Minimal amount of travel (on an as needed basis) to participate in off-site meetings (project / training / scientific).

Qualifications

  • Bachelor’s degree (BS) in an engineering field;
  • Master’s degree in Engineering (prefered);
  • 5+ years of product development experience in the medical device, consultant, and/or consumer health industries managing projects throughout the product life cycle;
  • PMP Certification (prefered);
  • Demonstrated ability to effectively communicate with external partners, clients, team members, vendors, and management;
  • Demonstrated ability to lead and manage a diverse cross-disciplinary team of developers across a variety of engineering domains including electrical, software, firmware, mechanical, verification, validation testing, and system integration and commercialization;
  • Ability to perform risk analyses including hazard, design, and process failure analysis;
  • Demonstrable experience in defining market and product requirements and use of tools such as focus groups to help define/verify requirements;
  • Technically savvy; must be able to discuss and understand decisions regarding a wide array of engineering disciplines and complex technical/logistical issues;
  • Knowledge of project management techniques and tools including Microsoft Project, JIRA, AGILE, resource tracking tools, and budgets;
  • Demonstrable experience and familiarity with GMP and design control processes as defined by ISO and FDA guidelines;
  • A commitment to our core values of innovation, passion, agility, openness, integrity, and social responsibility;
  • Excellent communication and interpersonal skills, negotiating; planning and organizing teamwork; ability to address difficult situations; conflict resolution; resource constraint and problem solving.

Additional Information

Please note:

  • At this time, Simbex is unable to sponsor employment Visas and will only consider applicants who are authorized to work in the United States.
  • Due to the nature of our work, Simbex requires regular onsite work for all employees. Therefore, 100% remote work is not an option.