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 with cross-functional product development teams
• FEA/CFD modeling experience
• Experience with plastic injection-molded part design
• Experience with designing for large scale automation

Skills & Competencies:

• Proficiency in 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 (Project, Word, Excel, PowerPoint, Visio, Outlook)
• 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 team and departmental objectives
• Possesses working knowledge in FDA, CE Regulatory, or New Product Design processes
• Demonstrates technical coaching and leadership of peers
• Knowledge of global industry standards (ex. ISO, AAMI, ANSI, etc.)
• Strong internal leadership, influencing and negotiating skills
• Competent with SolidWorks software
• Demonstrated ability to provide 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 and development of medical device products and components that adhere to company procedures, industry regulations and customer standards
• Apply mechanical engineering principles and techniques to solve challenges related to product design, manufacturing, assembly, and testing
• Convert user needs to input, develop statistically sound design verification and validation strategies, and conduct risk management activities
• Develop product specifications, drawings, test protocols and reports
• Generates design history files following FDA and international standards
• Work with functional managers and partners to ensure project goals are met
• Contributes to internal project planning and execution to meet schedule and budget requirements
• Provide project and technical communication to cross functional teams for devices through clinical development, product registration and commercialization
• Significant contributions to the development of new designs and/or processes at all stages, from concept creation to launched product
• Produces design models, drawing details, assembly drawings, and associated engineering documentation with 3-D parametric modeling software, MS Word, MS Excel and MS Power Point
• Assist to 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
• Support 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
• Assist with identifying and communicating product and Product Development related objectives, issues, risks, and where applicable, facilitate cross-PD discussion on impact
• Support project strategies that match Enable product and pharma partner goals
• Understand and follow the New Product Development process with a focus on quality
• Assist with identifying project risks through comprehensive mitigation assessment and planning techniques and work with partners to develop project plans and project risk analyses for all assigned projects.
• Provide technical guidance and coaching of other engineers
• Assists in project planning and assures alignment with leadership objectives and priorities
• Supports strong collaborative relationships with external design/development, manufacturing partners and service providers