Project Manager - Biomedical

Associates Systems LLC

$90K — $120K *
Pharmaceuticals & Biotech
5 - 7 years of experience
Job Overview by Ladders

Qualifications

  • 5+ years in product development engineering, ideally in medical devices
  • BS in Engineering required; advanced degree preferred
  • PMP certification desired
  • Experience with Scrum and Agile methodologies
  • Knowledge of medical device regulations and design controls

Responsibilities

  • Lead execution of product development programs according to set processes
  • Motivate and manage cross-functional team performance
  • Balance electrical, mechanical, and software engineering challenges
  • Develop project work plans and schedules
  • Manage requirements and ensure traceability
  • Conduct design reviews and risk management activities
  • Coordinate with technical partners and vendors

Benefits

  • Opportunity to work on innovative medical device projects
  • Engagement with a cross-functional team
  • Exposure to a variety of engineering disciplines
  • Chance to develop leadership and project management skills
  • Support for professional development and certifications
Full Job Description
Based on priorities set by Program Directors, the Project Manager is responsible for the successful execution of major product development projects. This position plans, coordinates and leads the execution of activities to ensure that the goals and objectives of the project are accomplished within the prescribed timeframe and funding parameters.
The position is technical in nature and the applicant must have an engineering background in order to manage and contribute to the development of new products. The projects that will be managed include a mix of new product development, product line extensions, and sustaining engineering releases.
Essential Functions:
  • Lead the execution of assigned product development programs in accordance with established processes and procedures.
  • Lead and motivate cross-functional team performance toward the goal of completing projects according to the defined objectives.
  • Ability to balance electrical, mechanical, and software development issues at the system level. Must have the ability to implement projects outside technical area of expertise
  • Develop detailed project work plans and schedules.
  • Manage product requirements and traceability.
  • Lead design review and risk management activities.
  • Manage technical partners/ vendors supporting product development activities.
  • Effectively utilize problem solving skills and techniques to identify potential issues, assess their impact, and develop and implement mitigation and resolution plans and activities.
  • Employ excellent interpersonal, communication and negotiation skills with all levels of personnel and management.
  • Prepare and/or manage the preparation of all required project documentation.
  • Facilitate and coordinate project team meetings and management presentations as required.
Skill Requirements:
  • Experience with Scrum and Agile processes
  • Knowledge of global standards and regulations for Design Controls, Risk Management, and Electrical Safety for Medical Devices.
  • Demonstrated aptitude for successfully managing multiple projects, of varying complexity, within the specified guidelines, timeframes and budgets.
  • Demonstrated understanding of electrical, mechanical, and software engineering practices at the system level.
  • Experience working within a phase-gate development process
Required/ Preferred Education and Experience:
  • 5+ years of experience as an engineer developing products, preferably in the medical device industry.
  • BS degree in Engineering (Advanced degree preferred)
  • PMP certification desired
Other Duties:
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job.Duties, responsibilities, and activities will be reviewed periodically as duties and responsibilities change with business necessity.Essential and marginal job functions are subject to modification

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