Product Development Engineer

This is an excellent full-time opportunity for a Product Development Engineer to join a growing medical device company to help develop new products.  Job Description:  The Product Development Engineer will perform implant and instrument design work as well as actively participate on and/or lead multifunctional teams to advance projects through the design /development process and ultimately through market launch. Essential Functions:  Actively participate on, and at times lead, cross-functional teams to develop new medical devices as well as address design issues / maintenance of existing products Lead product development projects from concept evaluation to product launch Model and create detailed drawings of implant and instrumentation designs utilizing Solidworks CAD software Develop prototypes for concept evaluation, design verification and validation Interface with Marketing and clinical professionals to gather input for design and evaluation of new products Utilize / manage Design Controls Write technical protocols and reports, and perform / oversee testing Utilize knowledge of all aspects of the surgical procedure in order to develop innovative solutions to solve / satisfy customer needs Develop and manage project plans and timelines within the scope of the new product development guidelines Aid in the development process by ensuring designs are cost efficient, manufacturable and reliable Support Quality and Manufacturing departments as needed Qualifications/Work Experience:   Bachelor’s degree in Mechanical or Biomedical Engineering, or related discipline 1-5 years of product development experience in the medical device industry Orthopaedic device experience preferred, including development of titanium, stainless steel, and polymer implants and/or instruments Thorough understanding of FDA design controls and requirements for Class II devices Knowledge of GD&T preferred  Experience with 3D CAD software (Solidworks preferred) Effective interpersonal communication skills and attention to detailAbout Us:  Omni One has 20 yrs local experience, established as a permanent placement and contract services provider. We take pride in finding career opportunities for people and people for career opportunities. Our services are 100% Employer paid.   We specialize in Engineering, and Information Technology. Let our team of experienced Personnel Consultants help you in your next transition.   For additional information and job postings, please visit our web site at: www.omnione.com   You may also email us directly at: Irvine@omnione.com Or call us at: 949.753.0300 Or fax us at: 949.753.0707