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