Title: Staff Project Engineer, Product Development
Description
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 leading cross-functional development teams
Project Management Professional (PMP) Certification
Skills & Competencies
Highly skilled in project management fundamentals and best practices, Gannt 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)
Strong analytical and demonstrated problem-solving 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 leadership of peers
Knowledge of global industry standards (ex. ISO, AAMI, ANSI, etc.)
Strong internal leadership, influencing and negotiating skills
Demonstrated ability to lead and drive 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.
Essential Functions
Ability to independently adapt behaviors and strategies to deal with emergent, non-routine and dynamic components of the job. Anticipates the need to shift priorities to provide the best possible response to cross functional teams
Strong ability to understand complexity and navigate ambiguity to influence at the cross functional level
Plan and carry out multiple projects concurrently
Ability to analyze problems and troubleshoot solutions
Apply strong cognitive ability to collecting, processing, and disseminating information
Understand current state and dynamics of the business. Ability to anticipate future changes and developments
Strong ability to foster teamwork, collaboration, negotiation, coaching, and influencing others
Consistently sought out to resolve highly sensitive and complex issues within the department
Engages colleagues and partners with the Enable Values in mind
Ability to maintain a positive attitude, show empathy for others, and always do the right thing
Ability to understand your own emotions and their effects on your performance
Ability to express your emotions appropriately and understand how others feel
Make a positive impact on others in support of company goals and a healthy work environment
Excellent time management skills
Position requires being physically present on the premises during regular company hours or as approved by management
Responsibilities
Lead the design control deliverables of medical device products and components that adhere to company procedures, industry regulations and customer standards
Lead 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
Directly communicate with partners to communicate strategy of the programs
Convert user needs to input, develop statistically sound design verification and validation strategies, and conduct risk management activities
Manage and strategize 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
Lead 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
Identify and communicate product and project related objectives, issues, risks, and where applicable, facilitate cross-functional discussion on impacts
Generate project strategies that match Enable product and pharma partner goals
Understand and follow the New Product Development process with a focus on quality
Provide coaching of other engineers
Assist in project planning and assures alignment with leadership objectives and priorities
Support strong collaborative relationships with external design/development, manufacturing partners and service providers
Nearest Major Market: Cincinnati
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