Project Engineer III, Product Development

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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