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QUALIFICATIONS
Required:
- Bachelor'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
Preferred:
- Experience in developing and commercializing regulated medical devices
- Project Management Professional (PMP) Certification
Skills & Competencies:
- 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
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.
- Position requires being physically present on the premises during regular company hours or as approved by management
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
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