QUALIFICATIONS

Required:

• Bachelor's degree or higher in Mechanical Engineering, Biomedical Engineering, or related engineering 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 coordinating and driving cross-functional product development teams
• Experience in root cause investigation and failure analysis
• Experience in project planning/scheduling and self-regulated time management
• Experience with plastic injection-molded part design, assembly and fabrication methods, and plastic material properties (resins and silicones)
• Experience with designing for large scale automation
• Knowledge of global industry standards (ex. ISO, AAMI, ANSI, etc.)

Skills & Competencies:

• Proficiency in mechanical design fundamentals, solid modeling, tolerance stack analysis, design for manufacturing and assembly, Geometric Dimensioning and Tolerancing (GD&T), and statistical analysis
• Strong analytical and demonstrated problem-solving skills
• Excellent verbal communication, technical writing, and presentation skills
• Demonstrated ability to prioritize tasks and lead a varied workload to meet departmental and company objectives
• Working knowledge in FDA, CE Regulatory, and/or Design Control processes
• Demonstrated technical coaching and leadership of peers
• Strong cross functional internal leadership, communication, influencing and negotiating skills
• Competent with SolidWorks software
• Proficiency utilizing the MS Office Suite (Project, Word, Excel, PowerPoint, Outlook)

Physical Requirements:

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

RESPONSIBILITIES:

• Lead the design and development of medical device products and components that adhere to company procedures, industry regulations, and customer standards
• Significantly contribute to the development of new designs and/or processes at all stages, from concept creation to launched product
• Apply mechanical engineering principles and techniques to solve challenges related to product design, manufacturing, assembly, and testing
• Convert user needs to design inputs and develop statistically sound design verification and validation strategies
• Develop and review models, drawings, specifications, test protocols, engineering reports, and other associated engineering documentation
• Promote visibility and transparency of information within product development and other forums to accelerate decision making, obtain alignment, and increase foundational knowledge
• Provide technical guidance and coaching of other engineers
• Support project strategies that match Enable product and pharmaceutical partner goals
• Work with functional managers and project management leaders to contribute to internal project planning and execution to ensure company goals are met
• Assist to establish and maintain detailed project plans including defining risks through comprehensive mitigation assessment and planning techniques
• Provide project and technical communication to cross functional teams for devices through clinical development, product registration and commercialization
• Understand and follow the New Product Development process with a focus on quality
• Ensure accurate and controlled documents are generated
• Assist in nonconformance, complaint, and failure investigations
• Design test fixturing and methods to assess design feasibility and performance limits
• Identify and communicate product and Product Development related objectives, issues, and risks and facilitate interdepartmental and cross functional discussion on impacts
• Support strong collaborative relationships with external design and manufacturing partners and service providers