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Staff Project Engineer, Product Development

Enable Injections

Enable Injections

Product
Posted on Monday, January 29, 2024

QUALIFICATIONS

Required:

  • Bachelor's degree or higher in Mechanical Engineering, Biomedical Engineering, or related field from an accredited university
  • A minimum of 8 years of product development experience; OR master’s degree plus 6 years’ experience

Preferred:

  • Advanced Engineering Degree
  • Experience in developing and commercializing regulated medical devices
  • Experience leading cross-functional development teams
  • Project Management Professional (PMP) Certification

Skills & Competencies:

  • Highly skilled in project management fundamentals and best practices, Gantt charts, and associate programs (e.g., Microsoft Project).
  • Excellent verbal communication, technical writing, and presentation skills
  • Knowledge of mechanical design fundamentals, solid modeling, tolerance stack analysis, design for manufacturing, Geometric Dimensioning and Tolerancing (GD&T), and statistical analysis
  • Proficiency utilizing the MS Office Suite (Word, Excel, PowerPoint, Visio, Outlook)
  • Strong analytical and demonstrated problem-solving skills
  • Demonstrated ability to prioritize tasks and lead a varied workload to meet team and departmental objectives
  • Possesses working knowledge in FDA, CE Regulatory, or New Product Design processes
  • Demonstrates leadership of peers
  • Knowledge of global industry standards (ex. ISO, AAMI, ANSI, etc.)
  • Strong internal leadership, influencing and negotiating skills
  • Demonstrated ability to lead and drive cross-functional communication

Physical Requirements:

  • Must be able to remain in a stationary position for extended periods of time
  • Ability to constantly operate a computer and other office equipment, such as printer, telephone, etc.

RESPONSIBILITIES:

  • Lead the design control deliverables of medical device products and components that adhere to company procedures, industry regulations and customer standards
  • Lead cross-functional teams to complete projects based on platform and customer needs
  • Provide project and technical communication to cross functional teams for devices through clinical development, product registration, commercialization and sustaining
  • Directly communicate with partners to communicate strategy of the programs
  • Convert user needs to input, develop statistically sound design verification and validation strategies, and conduct risk management activities
  • Manage and strategize change implementation for the device and projects they own
  • Develop product specifications, test plans and reports
  • Generate design history files following FDA and international standards
  • Work with functional managers and partners to ensure project goals are met
  • Support internal project planning and execution to meet schedule and budget requirements
  • Establish and maintain detailed project plans, define risks and recommend contingency plans as required
  • Ensure accurate and controlled documents are generated
  • Assist in deviation, complaint and failure investigations
  • Lead operational planning activities ensuring alignment to program strategy
  • Promote visibility and transparency of information within product development and other forums to accelerate decision making, obtain alignment, and increase foundational knowledge
  • Identify and communicate product and project related objectives, issues, risks, and where applicable, facilitate cross-functional discussion on impacts
  • Generate project strategies that match Enable product and pharma partner goals
  • Understand and follow the New Product Development process with a focus on quality
  • Provide coaching of other engineers
  • Assist in project planning and assures alignment with leadership objectives and priorities
  • Support strong collaborative relationships with external design/development, manufacturing partners and service providers