Senior R&D Engineer, Tissue Expander System-7339140617
Description
Mentor is currently searching for a Senior R&D Engineer, Tissue Expander System located in Somerville, NJ.
Mentor Worldwide L.L.C. is a trusted global leader in aesthetic medicine among both consumers and clinicians by providing a broad range of innovative, science and clinical-based solutions to maintain, enhance, and restore self-esteem and quality of life. This position will primarily be focused on products used for breast reconstruction and augmentation.
This position will be focused on new product development, product line extensions or existing product improvements. The Senior Engineer will develop designs and techniques to solve technical challenges or improve existing products or processes. This individual will be expected to complete assignments involving a specific phase of an engineering project which may include design, development, testing, using appropriate statistical techniques. Plan, conduct & direct engineering assignments to completion. Conduct assignments encompassing entire project or a large portion of a major project, setting overall project objectives, planning schedules, defining direction & contributing in other functional areas as needed. Expected to help manage the partners and other external vendors to meet project requirements and deadlines. The Senior Engineer may also lead cross function and global teams in the pursuit of new product development projects or change control project. Apply comprehensive & diverse knowledge of engineering principles to a broad range of assignments. May co-ordinate, direct activities of other technical support staff. This position will require collaboration with external (e.g. clinicians) and internal customers (e.g. Marketing) to refine needs and implement changes. Additionally, the Senior Engineer will cross-functionally collaborate within teams, such as Clinical, Regulatory, Quality, Manufacturing etc. to ensure development of innovative and reliable devices to fulfill clinical needs within regulatory requirements.
Complete training in area of responsibility within allowed time-period. Training is required for changes in existing policies & procedures, for new assignments & for implementation of new policies & procedures. Follow all company safety policies & other safety requirements within work area. Other responsibilities may be assigned & not all responsibilities listed may be assigned.
Other responsibilities include: Applies intensive and diversified knowledge of engineering principles and practices in broad areas of assignments and related fields. Makes decisions independently on engineering problems and methods, and represents the organization in conferences to resolve important questions and to plan and coordinate work. Requires the use of advanced techniques and the modification and extension of theories, precepts and practices of his/her field and related sciences and disciplines. Supervision and guidance related largely to overall requirements, critical issues, new concepts, and policy matters. Consults with supervisor concerning unusual problems and developments. Responsible for or more of the following: In a supervisory capacity, plans, develops, coordinates, and directs a large important engineering project or a number of small projects with many complex features. As an individual researcher, carries out complex or novel assignments requiring the development of new or improved techniques or procedures. Work is expected to result in the development of new or improved techniques or procedures. Work is expected to result in the development of new or refined equipment, materials, processes, products, and/or methods. As a senior specialist, develops and evaluates plans and criteria for a variety of projects and activities to be carried out by others. Assesses the feasibility and soundness of proposed engineering evaluation tests, products or equipment when necessary data are insufficient or confirmation by testing is advisable. Performs as a senior consultant on a technical specialty, a type of facility or equipment, or a program function. May technically supervise, coordinate and review the work of a small staff of engineers and technicians, estimates manpower needs and schedules and assigns work to meet completion date, or, as individual researcher or senior specialist may be assisted on projects by other engineers or technicians. Practices company safety and quality policies and procedures. Actively requires conformance. Responsible for ensuring personal and company compliance with all Federal, State, local and company regulations, policies and procedures for Health, Safety and Environmental compliance. Responsible for the purchase or design of equipment that meets health, safety and environmental standards set by the company. Responsible for performing design reviews and pre-validation assessments to ensure the safe and environmentally sound start-up of new processes.
Qualifications
A Bachelors of Science Degree in Engineering (Mechanical Engineering is preferred) or similar technology with a minimum of 5-7 years of experience working in industry OR a Master’s Degree with a minimum of 3-5 years of experience working in industry OR a Ph.D. with 0-2 years of experience working in industry is required for this position. Previous experience in medical device or a similar healthcare discipline is strongly preferred. Strong quality engineering skills with a proven track record in design verification/validation, process verification/validation, and design/process failure modes and effects analyses is strongly preferred. Demonstrated understanding of various types of manufacturing, mechanisms, materials, proper tolerancing, drafting standards, and an understanding of GD&T is required. Experience in project management is required, a PMP certification is preferred. Strong experience in product development or design control experience is required. A person in this position should have demonstrated ability to coordinate multiple team activities independently. It is required that the person in this position will have demonstrated experience in leading multiple complex projects. This role requires a creative, hands-on engineer to design and develop new medical devices from concept through product launch. Knowledge and experience in implementing projects in accordance with Design Control requirements is highly desirable. Specific experience in system integrations and electromechanical design is an asset. Metals & Plastics component process development is an asset. Experience with the use of silicone polymers in device design and assembly techniques preferred but not required. Assembly Process Development, Design for Manufacturing/ Design for Assembly. Experience with managing outside vendors and suppliers are also an asset. Ability to create tooling and fixturing designs for testing and production. Knowledge of CAD software (Pro Engineering, Pro-E, Solid Works, AutoCAD, etc.) is required Must possess a clear mastery of theoretical and practical fundamentals and experimental engineering techniques. Must have ability to manage several projects. Must possess clearly recognizable outstanding technical qualifications and leadership. Must demonstrate a strong initiative and follow through in executing project responsibilities, overcoming obstacles and balancing multiple priorities effectively through strong technical and/or project leadership experience. Prior experience coaching, mentoring, train and developing staff are strongly preferred. Candidate should possess excellent problem solving, decision-making, and root cause analysis skills in addition to interpersonal skills that foster conflict resolution as it relates to technical situations. A successful track record of leading and influencing others without authority, participating on cross-functional teams and solid negotiating skills to bring products from concept to launch is required. Must have the ability to effectively communicate concepts, ideas and knowledge to upper management, other individuals, customers and/ or teams across the organization is required. Willing to work with cadavers and within an Operating Room setting is required. This position will be based in Somerville, NJ and requires up to 25% travel, with the potential for international travel.
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Primary Location:North America-United States-New Jersey-Somerville
Organization: Mentor Worldwide LLC (6177)
Job Function: R&D Engineering (R&D)
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