Position Title
Product Development Engineer
SBU
OEM
Department
Engineering
Relocation Covered
YES
Educational Requirements
Bachelor's degree
Experience Requirements
Education: Minimum BS in Engineering , Plastics, Mechanical and/or Biomedical Engineering. Work experience: Minimum 3-5 years of medical device product-process and related technology development experience
Qualification Requirements
The ability to work within an organization and across functional boundaries to get programs accomplished within the quality and manufacturing guidelines at each facility. The ability to manage development programs across multiple locations and project teams is required. Working knowledge of polymer and polymer processing. Experience with Medical Device Regulatory pathways and new product submission pathways are highly preferred. The ability to travel to customer accounts, suppliers and alternate manufacturing locations as needed is required. (Estimated Travel is 5%-10%). Knowledge of the QSR requirements for medical devices is required. This includes design control for contract manufactured and new product development efforts. Development skills are required for this position. This individual must have a track record of project management, problem solving, solid decision-making and project completions skills.
Preferred Qualifications
Working knowledge of sutures and suture related devices is a plus, M.S. Engineering, 6+ years experience
Responsibilities
Responsible for the design and development of new products and line extensions. Design, develop and validate new products as part of a multi-functional development team. Optimize designs for manufacturing and assist in physical and in vivo testing. Assist in the establishment of specifications & procedures. Performs design control activities such as aiding in the identification of the Design Inputs, participating in Design Reviews, and generates records for the Design History File. Assists in the creation of Design and Process FMEA's and Risk Analysis. Works closely with external OEM customers to identify product needs and report on-going progress. Participates in the overall product development process including developing project schedules, scheduling regular meetings and discussions around project priorities, status updates. Ability to plan, manage and communicate multiple projects effectively and independently at all level of product-process development stages.
Home
