Position: R&D Product Development Engineer (Medical device)

Location: Tempe, AZ

Duration: 12+ Months contract

Total Hours/week: 40.00

Client: Medical Device Company

Employment Type: Contract on W2 (Need US Citizens, GC Holders)

Primary focus of this position is to support R&D efforts needed to support new and existing combination medical device products. Candidate will work cross functionally on projects and will be responsible drafting and executing change orders needed to support the projects in a timely manner; prepare work instructions and standard operating procedures; conduct process qualification and validation; support equipment development; support other activities from R&D, Quality, Operations and Regulatory Affairs. Responsibilities: Support engineers on new and existing projects. Develop and validate test methods and procedures. Conduct change request to make updates to processes, prints, labels, artwork, etc. Support new process equipment development, including specification development, vendor selection, and negotiation. Qualifications: Education: B.S. degree in Biomedical Engineering, Mechanical Engineering or other related engineering discipline. Experience: 0-1 years of industrial experience in R&D or process development, preferably in medical device or other regulated FDA/QSR and ISO environment. Preferred Qualifications: Training in Six Sigma or Design for Six Sigma. Ability to analyze data, interpret results and write reports. Proficient in statistic software, such as MiniTab, is a plus. Demonstrated hands-on technical aptitude Excellent oral and written communication skills Knowledge of cGMP and GLP is a plus. Physical Demands: While performing the duties of this job, the employee may be required to stand, walk, sit and use hands to manipulate tools, controls and office equipment. Work may involve continuous computer use with repetitive motion to wrists, hands and fingers. The employee frequently is required to see, talk and hear. The employee is occasionally required to bend, lift, reach or stoop. Inability to meet one or more of these physical demands will not automatically disqualify a candidate or employee from the position

Description:

Provide solid technical skill and engineering support for design and development activities for new and existing products. Support current products in terms of quality, manufacturing, supply continuity and cost improvement. Participate in executing technical and/or cross-functional project work. Contribute to a culture of innovation by proactively generating novel concepts for new products and enhancements to current product performance. Understand customer needs through literature review, customer interviews, direct observation, competitive analysis, prototype evaluation, and clinical/simulated use studies. Translate customer needs into engineering requirements into specific product, packaging and process specifications. Engineer robust and manufactural products through strong understanding and application of engineering fundamentals. Develop and execute test methods which specify measurement equipment, test set-up, measurement systems analysis, and data analysis. Write detailed technical reports based on design verification analysis/testing for design changes and product design activities. Ensure compliance with BD quality policies, procedures and practices as well as with all local, state, federal and BD safety regulations, policies and procedures. BS degree in engineering is required (Mechanical or Biomedical Engineering preferred). 0-2 years of engineering experience is required, preferably in medical devices. Demonstrated ability to utilize statistical tools and computer analysis.