R&D Mechanical Engineer II, IVP at Halyard
Posted in Engineering 30+ days ago.
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Location: Tucson, Arizona
Job Description SummaryWe are currently recruiting for a R&D Mechanical Engineer, Sustaining Engineering & Manufacturing in our Tucson, AZ office.
Halyard Health’s Interventional Pain Management R&D group is seeking an experienced Mechanical Engineer to join our team in Tucson, AZ. This position will report to the R&D Associate Director of Interventional Pain in Alpharetta, GA. The ideal candidate must have a strong track record for developing, sustaining and/or manufacturing of Medical Devices & Accessories. In this role, you will be given the autonomy & flexibility to grow your skills & your career, while effectively delivering world class results. At Halyard Health, we value ownership & a sense of urgency. We continually strive to cultivate & grow our relationships with our cross-functional peers & external partners while meeting or exceeding the needs of our customer base.
The incumbent will lead all R&D efforts related to the Needle, Kits & Tray business. Examples of such devices includes; epidural catheters, spinal needles, and Loss of Resistance Syringes. The incumbent will also lead manufacturing related sustaining R&D efforts for Interventional Pain Devices & Accessories. In this role, you will act as a liaison to travel and communicate between the production facilities located in the US/Mexico and staff engineering located in Alpharetta, GA.
Other responsibilities include the following: Leading projects of small to moderate size and complexity, perform as an indispensable team member on a project of moderate complexity, lead technical interactions with customers regarding product requirements and therapy methods, effectively plan and complete project responsibilities on time, ensure communication of project plans and results to customers and other team members and provide protection of technologies and products through appropriate use of patents and trade secrets.
- Provide leadership and collaboration within a cross functional team during the execution of product sustainability projects. Work closely as a liaison with staff and production facilities to ensure complete and accurate integration of Pain Management products and any product improvements.
- Manage self in accordance with the expected behaviors of the Safety and Leadership Qualities. Effectively achieve results that meet business and individual objectives.
- Provide technical expertise in the design, development, and manufacture of Pain Management products and accessories including spinal access, injection devices, epidural catheters, spinal needles, syringes & radiofrequency (RF) Devices.
- Implement engineering standards and scientific analysis principles to initiate and develop product improvements.
- Define testing and equipment needs to support all device requirements including bench testing equipment installations and validations.
- Identify, troubleshoot, and resolve issues related to manufacture of Pain Management products.
- Prepare and manage budgets and schedules related to Pain Management projects.
- Investigate and qualify material changes to replace obsolete materials for current products as needed to assure production continuity.
- Troubleshoot and improve production processes, investigate and implement alternate processes to improve yield, reduce scrap, etc. Provide technical expertise and leadership in the planning and implementation of projects to improve and/or revalidate existing manufacturing processes.
- Bachelor’s Degree in Mechanical Engineering.
- A minimum of 3-5 years of work experience in design & development and/or sustaining engineering for interventional medical devices.
- Excellent verbal and written communication skills.
- Mechanical Design experience.
- Knowledge of statistics and use in medical device V&V.
- Knowledge of SolidWorks or other solid modeling software.
- Up to 25% travel will be required in this role including frequent travel to Mexico.
- Fluent in Spanish.
- Previous experience in a manufacturing environment.
- Experience with process, sustaining (Life Cycle Management), or development engineering of electromechanical medical device disposables.
- Knowledge and experience in epidural and/or spinal access for injectable drugs.
- Experience with injection molding and low to medium volume manufacturing tooling development.
- Experience with design and development of RF energy delivering disposables and packaging (probes, needles, catheters, etc.).
- Experience developing peripheral and disposable devices that work in conjunction with (electro-mechanical software system) medical devices.
- Design and execution of product testing, creation of technical files for regulatory submission.
- Knowledge of Quality Systems requirements for medical devices, with strong skills in Requirements Management and Risk Management.
Halyard Health is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, sexual orientation, gender identity or any other characteristic protected by law.
If you are a current employee of Halyard Health or Owens and Minor, please apply here.