Staff Engineer, Product Development

Enable Injections Inc.•Sharonville, OH

1d•Onsite

About The Position

This role involves leading the design and development of medical device products and components, ensuring adherence to company procedures, industry regulations, and customer standards. The position significantly contributes to the development of new designs and/or processes throughout all stages, from concept creation to launched product. It requires applying mechanical engineering principles to solve challenges in product design, manufacturing, assembly, and testing, as well as converting user needs into design inputs and developing statistically sound design verification and validation strategies. The role also involves developing and reviewing various engineering documentation, promoting information visibility within product development, and providing technical guidance and coaching to other engineers. Additionally, it supports project strategies aligned with company and partner goals, contributes to internal project planning and execution, and assists in establishing detailed project plans with risk assessment. The Staff Engineer will provide project and technical communication to cross-functional teams throughout the device lifecycle, from clinical development to commercialization, while understanding and following the New Product Development process with a focus on quality. Responsibilities include ensuring accurate and controlled documents, assisting in investigations of nonconformances, complaints, and failures, designing test fixturing, and identifying/communicating product development objectives, issues, and risks. Strong collaborative relationships with external partners are also a key aspect of this role.

Requirements

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
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

Nice To Haves

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.)

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