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Location: Onsite
Status Type: Full Time
QUALIFICATIONS
Required:
- Bachelor's degree or higher in Mechanical Engineering, Biomedical Engineering, or related engineering 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 coordinating and driving cross-functional product development teams
- Experience in root cause investigation and failure analysis
- Experience in project planning/scheduling and self-regulated time management
- Experience with plastic injection-molded part design, assembly and fabrication methods, and plastic material properties (resins and silicones)
- Experience with designing for large scale automation
- Knowledge of global industry standards (ex. ISO, AAMI, ANSI, etc.)
Skills & Competencies:
- Proficiency in mechanical design fundamentals, solid modeling, tolerance stack analysis, design for manufacturing and assembly, Geometric Dimensioning and Tolerancing (GD&T), and statistical analysis
- Strong analytical and demonstrated problem-solving skills
- Excellent verbal communication, technical writing, and presentation skills
- Demonstrated ability to prioritize tasks and lead a varied workload to meet departmental and company objectives
- Working knowledge in FDA, CE Regulatory, and/or Design Control processes
- Demonstrated technical coaching and leadership of peers
- Strong cross functional internal leadership, communication, influencing and negotiating skills
- Competent with SolidWorks software
- Proficiency utilizing the MS Office Suite (Project, Word, Excel, PowerPoint, Outlook)
- 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
Physical Requirements:
- Must be able to remain in a stationary position for extended periods of time
- Ability to 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:
- Lead the design and development of medical device products and components that adhere to company procedures, industry regulations, and customer standards
- Significantly contribute to the development of new designs and/or processes at all stages, from concept creation to launched product
- Apply mechanical engineering principles and techniques to solve challenges related to product design, manufacturing, assembly, and testing
- Convert user needs to design inputs and develop statistically sound design verification and validation strategies
- Develop and review models, drawings, specifications, test protocols, engineering reports, and other associated engineering documentation
- Promote visibility and transparency of information within product development and other forums to accelerate decision making, obtain alignment, and increase foundational knowledge
- Provide technical guidance and coaching of other engineers
- Support project strategies that match Enable product and pharmaceutical partner goals
- Work with functional managers and project management leaders to contribute to internal project planning and execution to ensure company goals are met
- Assist to establish and maintain detailed project plans including defining risks through comprehensive mitigation assessment and planning techniques
- Provide project and technical communication to cross functional teams for devices through clinical development, product registration and commercialization
- Understand and follow the New Product Development process with a focus on quality
- Ensure accurate and controlled documents are generated
- Assist in nonconformance, complaint, and failure investigations
- Design test fixturing and methods to assess design feasibility and performance limits
- Identify and communicate product and Product Development related objectives, issues, and risks and facilitate interdepartmental and cross functional discussion on impacts
- Support strong collaborative relationships with external design and manufacturing partners and service providers
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