What are the responsibilities and job description for the Staff Project Engineer, Product Development position at Enable Injections, Inc.?
Title: Staff Project Engineer, Product Development
Description
QUALIFICATIONS
Required
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
- Advanced Engineering Degree
- Experience in developing and commercializing regulated medical devices
- Experience leading cross-functional development teams
- Project Management Professional (PMP) Certification
- 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
- 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.
- 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
- 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