St. Jude Medical Mechanical Engineer II (Medical Device w/ Spinal Anatomy) in Plano, Texas

Mechanical Engineer II (Medical Device w/ Spinal Anatomy)

Plano, Texas, USA at

Engineering at

Global R&D

160001ZRRequisition #

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We are seeking an experienced, high caliber Mechanical Engineer II. The Engineer will participate in the design and development of new products and accessories and upgrades to existing products. This position requires a mechanical engineer ready to support projects from initial concept, through development and verification/validation testing, and into manufacturing. This engineer will use a wide variety of technical skills and reasoning in analyzing mechanical systems (e.g. for stress and strain, wear, or defect), designing mechanical systems, designing and running tests (e.g. mechanical and/or reliability testing), improving or resolving product features, and documenting findings (e.g. protocol test reports, engineering memos). Excellent interpersonal skills are required for satisfying internal customers (e.g. in supporting Manufacturing Engineering, Production, Materials, and Quality Assurance in sustaining engineering projects and meeting corporate goals) and external customers (e.g. in managing vendors and facilitating timely delivery of high-quality services and parts). Expected behavioral qualities include a positive outlook and affinity for teamwork and logic.

Each employee can make a difference at St. Jude Medical and has the power, either individually or as a team, to influence the success of the company. We are team-oriented, fast-paced and progressive. We value people with great ideas who partner with others both internally and externally to take action and accomplish goals.

Impact this role will have on St. Jude Medical:

•Design devices to meet user needs.

•Establish requirements and specifications for these devices (including justification and supportive testing).

•Use experimental, empirical and numerical analysis to evaluate designs. Lead test method and model development.

•Identify and mitigate project risks.

•Work with project management to develop overall schedule. Manage time and tasks within schedule.

•Work with internal departments and external vendors to obtain prototype parts and to expand these groups’ capabilities.

•Lead pre-clinical and support clinical testing of devices.

•Lead design reviews and support physician visits.

•Maintains a detailed understanding of the developing clinical environment (i.e. current treatment methods, evolving clinical needs etc.).

•Maintain a detailed understanding of SJM, FDA and ISO regulation. Provide input into shaping SJM quality and regulatory requirements.

•Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.

•Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.

•Performs other related duties and responsibilities, on occasion, as assigned.

Your experience(s), education and knowledge will further expand St. Jude Medical’s marketplace success:

•Bachelor’s degree in Mechanical Engineering.

•5+ years’ experience.

•Experience designing and testing closely related medical devices required.

•Ability to lead small teams and to work within large multi-discipline teams as an individual contributor in a fast-paced, changing environment.

•Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.

•Multitasks, prioritizes and meets deadlines in timely manner.

•Exposure to latest design tools and techniques (six sigma, DFM, analytical design).

•Ability to work in a highly matrixed and geographically diverse business environment.

•Ability to work within a team and as an individual contributor in a fast-paced, changing environment.

•Ability to leverage and/or engage others to accomplish projects.

•Multitasks, prioritizes and meets deadlines in timely manner.

•Strong organizational and follow-up skills, as well as attention to detail.

•Ability to travel approximately 10%, including internationally.

•Ability to maintain regular and predictable attendance.

Your preferred qualifications and education:

•Master’s degree in Mechanical Engineering.

Experience with Spinal Anatomy.

•Experience in polymer processing (injection molding, extrusion, reflow, bonding).

•Experience in test method development.

•Strong organizational and follow-up skills, as well as attention to detail.

•Analytical design, Design for Six Sigma, or similar tool set preferred.

•Experience working in a broader enterprise/cross-division business unit model preferred.

•Experience with a variety of manufacturing processes and designing for manufacturability preferred.