Staff Engineer, Product Development

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 stra