Looking for a R&D Engineer in the North Dallas area!Description:The overall goal of the R&D Engineer is to work on Research and Development projects including new product development and sustaining, design changes, product improvements, production support, and technical documentation creation and maintenance. This position interacts with all other departments and supports multiple projects at once. The R&D Engineer reports to the Principal R&D Engineer and needs to understand the corporate goals and objectives.Principal duties and Responsibilities:
Collaborate with R&D, Regulatory, Quality, and Marketing during new product development and sustaining projects to document product specifications, create and update design history files, update risk management files, technical files and lead changes through change control. Examples include:
Document user needs, marketing requirements, and design inputs and outputs,
Develop verification and validation test plans, and methods with external testing facilities,
Draft design verification and validation protocols and reports, and justifications,
Participate in the production and validation prototypes for consulting surgeons in simulated use settings
Collaborate with suppliers and Quality to transfer designs into production.
Update files as needed for design changes and process changes through change control
Provide technical support to regulatory for regulatory submissions.
Knowledge of sample size determination and statistical techniques a plus.
Knowledge of ISO 13485 and ISO 14971.
Propose product and process improvements. Implement improvements based on feedback from customers and suppliers.
Validate the technical aspects in all documentation including changes resulting from product complaints, non-conformances, audit findings, and CAPA’s.
Other responsibilities as assigned.
Up to 10% travel may be required.
Skills:
Medical device
New product development
Solidworks
Design
Mechanical engineering
Design control
Validation
Design History Record
Additional Skills & Qualifications:Qualifications and Requirements: Bachelor's degree in engineering (biomedical, mechanical, or similar). 2-3 years of experience in the medical device industry – orthopedic devices preferred. Experience with both new product development and product maintenance. Experience with design documentation including Design History Files and Design Controls. Experience working in and managing cross-functional project teams. Experience working with clinical or surgical consultants. Proficiency with Microsoft Office (Word, Excel, Powerpoint, Outlook). Proficiency with Computer-Aided Design, preferably SolidWorks).Experience Level:Intermediate LevelAbout Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.Diversity, Equity & Inclusion At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:
Hiring diverse talent
Maintaining an inclusive environment through persistent self-reflection
Building a culture of care, engagement, and recognition with clear outcomes
Ensuring growth opportunities for our people
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.
