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QUALIFICATIONS
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Required:
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- 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
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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.)
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Skills & Competencies:
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- 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.
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RESPONSIBILITIES:
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- 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
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