Inspire and Commit to Each Other
Our personal integrity, trust of our colleagues, and dedication to our work creates an environment of respect and excellence throughout Ameda®.
This Ameda Core Value leads to a team-oriented culture where all are challenged to think beyond the obvious. If you have a desire to learn, grow and innovate, you can find purpose and satisfaction with us. At Ameda, you can make a contribution to an industry dedicated to improving the lives of mothers and babies.
There is no typical day at Ameda. Our market and our customers are always changing. This results in a highly stimulating atmosphere, where each employee can flourish based on his or her area of expertise.
Ameda is committed to creating opportunities for qualified, enthusiastic employees who want to broaden their skills. Our growth makes it possible to offer a spectrum of development options. We are interested in learning more about you. Resumes can be sent to Recruiting@ameda.com.
Research and Development Engineer
We are seeking a Research and Development Engineer for our in-house Engineering team.
Research and Development Engineer
Ameda is looking for a Research and Development Development Engineer to help with sustaining Engineering as well as act as a go-between with manufacturing and technical support. Responsibilities include creating and updating documentation required for the design history file and device medical record for existing products. The Research and Development Engineer will coordinate with internal and external resources as necessary to successfully keep a medical product on the market.
- In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Ameda Quality Policy and all other documented quality processes and procedures.
- Work closely with and provide engineering support to various cross functional areas such as production, supply chain, and quality.
- Provide engineering support for cost reduction initiatives.
- Support all initiatives related to Research and Development sustaining engineering.
- Support or lead the resolution of product quality or performance issues for internal and external customers.
- Create and/or modify product design, specifications, drawings, procedures, CAD models (Solid works) and Engineering Change Requests in accordance with Ameda Quality system procedures.
- Create and conduct design verification and validation protocols and write reports.
- Validate design modifications in accordance to applicable industry standards and product specification.
- Provide engineering support in creating equipment preventative maintenance procedures and train production personnel on preventative maintenance.
- Acquire product and design knowledge required to sustain and improve design and test processes.
- Create and/or update Design History File documentation.
- Create and/or update Device Medical Record documentation.
- Perform other duties as assigned.
- Bachelor's Degree in Engineering (Mechanical, Electrical prefer)
- Minimum of 4+ years industry experience in Engineering.
Required Technical Competencies:
- Medical Device Experience or Regulated Industry
- Basic knowledge of statistics such as t-test, ANOVA, DOE, control charts, etc. (Minitab)
- Computer Skills (MS Office Suite)
- Demonstrated understanding of DHF and DMR documentation (Quality Management Systems)
- Demonstrated understanding of Corrective and Preventative Actions and Supplier Notices of Changes
- Project Experience - understanding of design and development procedures, milestones, etc...
- Excellent Verbal and Written Communication Skills
Desired Secondary Competencies:
- Six Sigma
- Regulatory Experience (FDA, UL, CE, CPSIA, etc...)
- Basic knowledge of SolidWorks.
- Pneumatics Experience
- Electronics Experience (motors, switches, circuit boards, etc...)
- Plastics Experience (injection molding)
- Consumer products Experience (Biomechanical, Human Factors, etc...)
- Experience with International Suppliers (namely Asia, Mexico)
Required Behavioral Competencies:
- Energy - Consistently maintains high levels of activity or productivity; sustains long working hours when necessary; operates with vigor, effectiveness, and determination over extended periods of time. Maintains positive working attitude.
- Planning and Organizing - Establishes courses of action for self and others to ensure that work is completed efficiently.
- Quality Orientation - Accomplishes tasks by considering all areas involved, no matter how small; shows concern for all aspects of the job; accurately checks processes and tasks; is watchful over a period of time.
- Decision Making - Identifies and understands issues, problems and opportunities; compares data from different sources to draw conclusions; uses effective approaches for choosing a course of action or developing appropriate solutions; takes action that is consistent with available facts, constraints, and probably consequences.
- Initiating Action - Takes prompt action to accomplish objectives; takes action to achieve goals beyond what is required; is proactive.
- Innovation - Generates innovative solutions in work situations; tries different and novel ways to deal with work problems and opportunities