This position requires an individual who has demonstrated a unique combination of skills and temperament – able to rapidly iterate and realize clever design concepts to solve challenging and nuanced problems while producing these results in a disciplined, well-documented manner. This position requires the skill to interact with a variety of internal and external parties including engineers, research scientists, quality assurance, machining vendors and contract manufacturers.
• Provides substantial individual technical contribution to the development of new medical device product(s) for drug delivery from initial design to market release
• Investigates/evaluates existing technologies and drives consensus for implementation among engineering staff to ensure effective product development
• Designs and implements new methodologies, materials, devices or processes
• Designs and/or conducts feasibility studies of the design to assess ability to function as intended
• Maintains detailed documentation throughout all phases of research and development
• Coordinates activities with outside suppliers and consultants to ensure the delivery of supplies or services needed to meet scheduled timelines
• Able to use sound judgment to prioritize tasks and can be relied upon to make tradeoffs to ensure that project objectives are met, while balancing personal tasks and deliverables.
• Comfortable managing and negotiating for resources within line function and/or offering assistance to peers and junior staff.
Essential Duties and Responsibilities:
• Resolves a wide range of design issues in imaginative as well as practical ways
• Works on complex technical issues where analysis of situations or data requires an in-depth evaluation of identifiable and/or variable factors.
• Communicates past and projected progress towards milestones and cost targets to assist in the management of device projects
• Demonstrates good judgment in selecting methods and techniques for obtaining solutions.
• Uses skills as a design engineering professional to propose design ideas for the introduction of new measurement, device and process technologies.
• Interacts with senior internal and external personnel.
• Interacts with other engineers and scientists in the development of novel instrumentation, devices and equipment.
• Provides problem definition by performing technical analysis and presenting solutions for review.
• Proposes design ideas for the introduction of new measurement, device and process technologies.
• Conceives primarily mechanically-oriented design solutions, but may possibly also involve electro-mechanical, electronic, optical and computer-controlled capabilities.
• Drafts and prototypes design concepts, implements in manufacturable form.
• Selects and specifies parts based on engineering analysis.
• Builds, tests and modifies device prototypes in a laboratory setting.
• Programs computers with data acquisition and instrument control capabilities.
• Documents work with clearly written reports and well organized design files.
• Communicates results in verbal presentations.
• Fully documents product improvements within ISO and cGMP guidelines.
• Works closely with manufacturing, tooling engineers, and contract manufacturers to transfer designs to manufacturing.
• Performs tolerance analysis and uses GD&T as needed to properly control design and manufacturability.
• Provides technical support for device commercial production.
• Works with product teams and customers to refine designs for specific applications.
• Develops relationships with key vendors and production shops.
• Develops concepts, and implements in manufacturable form.
• Creates innovative and economic design solutions utilizing Design for Manufacturability/Assembly targets.
• May assist in project management tasks.
• May direct the work of technicians or junior engineering staff.
• May lead limited-scope teams to solve well-defined problems and execute assigned tasks.
• May serve on line function workstreams defining work processes.
• A minimum of a Bachelors degree in an Engineering discipline is required. Equivalent experience may be accepted.
• A minimum of 5 years industry work experience is required.
• A minimum of 2 years experience in a medical device design environment or other regulated environment is preferred.
• Familiarity with the basic principles of FDA Design Control (21 CFR 820.30) is required.
• Demonstrated competence using a solid modeling computer aided design software such as Pro/Engineer or SolidWorks is required.
• Good computer skills are required. Labview, and other engineering software is a plus.
• Relevant experience with Finite Element Analysis (FEA), Computational Fluid Dynamics (CFD) and other simulation analysis software is a plus.
• Must possess mechanical aptitude, sound technical judgment and use structured decision-making techniques.
• Must be a mechanical 'hands-on' person with the ability to operate in R&D laboratory environment in support of research experiments.
• Must have an ability to provide technical engineering support and influence the work of others in a collaborative, team-oriented project environment.
• Knowledge of high volume and prototype materials, processes, and other manufacturing techniques is required.
• Good oral and written communication skills are a must.
Novartis - 20 months ago
Novartis AG, incorporated on February 29, 1996, is a Switzerland-based holding that, through its subsidiaries, is engaged in the research,...