QUALIFICATIONS
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Required:
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- 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
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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
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Skills & Competencies:
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- 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.
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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
- 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
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