Product Development Engineer
Hoover, AL - Onsite
ITAC Solutions is seeking an experienced Product Development Engineer for a Birmingham, Alabama, company. The ideal candidate will have a minimum 3 years’ experience with medical device product design and development.
What you’ll be doing (duties of this position):
- Develop concept designs based on design inputs.
- Develop product specifications, support prototype development, create and execute testing methodologies, and maintain detailed documentation to evaluate design feasibility.
- Investigate and report on industry and non-industry technologies.
- Submit ideas for patent filings.
- Evaluate/investigate design changes, product complaints, and non-conformances; effectively report findings and recommendations as per corporate procedures.
- Support project scope development.
- Generate design inputs and outputs to support the development process.
- Develop Design History Files and support subsequent Regulatory submissions.
- Create design verification and validation test plans and reports.
- Execute design verification and validation testing.
- Generate risk analysis documentation such as Failure Mode and Effects Analysis (FMEA) for new products.
- Design and implement new methodologies, materials, and/or processes to bring concepts to market.
- Participate in in-vitro and in-vivo studies, including animal and human evaluations as part of the development process.
- Interface and collaborate with Manufacturing, Quality, Regulatory, Quality, Research and Development, Sales, Marketing, Accounting, Customer Care, and outside vendors to accomplish assigned tasks.
- Present to colleagues and customers on products, device design, and applied engineering principles.
- Occasional travel may be necessary
What you’ll need to be considered (requirements):
- Minimum of 3 years of medical device product design and development experience.
- Proficient in MSWindows and MSOffice applications (Word, Excel, PowerPoint).
- Proficient in CAD design software (SolidWorks) preferred.
- Ability to interact with colleagues and customers in a professional manner.