Project Engineer III, Product DevelopmentEnable Injections, Inc. • Cincinnati, OH, US
Project Engineer III, Product Development
Enable Injections, Inc. • Cincinnati, OH, US
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job_description.job_card.job_descriptionBachelor's degree or higher in Mechanical Engineering, Biomedical Engineering, or related field from an accredited university A minimum of 4 years of product development experience; OR master's degree plus 2 years' experience Experience in developing and commercializing regulated medical devices Project Management Professional (PMP) Certification 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) Analytical and demonstrated problem-solving skills 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 Knowledge of global industry standards (ex. ISO, AAMI, ANSI, etc.) Internal leadership, influencing and negotiating skills Ability to independently adapt behaviors and strategies to deal with emergent, non-routine and dynamic components of the job Quickly adapts to a diverse array of changing needs, conditions, priorities, or opportunities Ability to understand complexity and navigate ambiguity to influence at the department level Apply strong cognitive ability to collecting, processing, and disseminating information Ability to foster teamwork, collaboration, negotiation, and influencing others Ability to express your emotions appropriately and have a positive impact on others in support of company goals and a healthy work environment 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. Position requires being physically present on the premises during regular company hours or as approved by management Full-time Mid-Senior level Engineering and Information Technology Medical Equipment Manufacturing
Overview
Join to apply for the Project Engineer III, Product Development role at Enable Injections, Inc.
Location : Cincinnati, OH (nearest major market)
Responsibilities
- Support design control deliverables of medical device products and components that adhere to company procedures, industry regulations and customer standards
- Support 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
- Convert user needs to input, develop statistically sound design verification and validation strategies, and conduct risk management activities
- Support 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
- 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
- Understand and follow the New Product Development process with a focus on quality
- Assist in project planning and assure alignment with leadership objectives and priorities
- Support strong collaborative relationships with external design / development, manufacturing partners and service providers
Qualifications
Required
Preferred
Skills & Competencies
Physical Requirements
Employee Type
Seniority Level
Job Function
Industries
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