Responsible for providing engineering support in the creation and the development of new medical device products (invasive and non-invasive).
Researches, develops, designs, and evaluates mechanical and electro-mechanical materials, components, assemblies, processes and/or equipment. Conducts feasibility studies to verify capability and functionality. Develops new concepts from initial design to market release. Directs support personnel and coordinates project activities.
Write and submit intellectual property (patents). Maintains detailed documentation throughout all phases of research and development. Investigates and evaluates existing technologies. Reviews or coordinates vendor activities to support development.
(Influence/Leadership) Establishes and cultivates an extensive network of support to facilitate completion of assignments. Participates in the development of less experienced staff by setting an example, providing guidance and work direction, and offering counsel. May lead a project team. Participates in determining goals and objectives for projects. Influences middle management on technical or business solutions. May interact with vendors.
(Planning/Organization) Plans and organizes non-routine tasks. Initiates or maintains work schedule. Establishes priorities of work assignments.
(Decision Making/Impact) Exercises judgment in selecting innovative, practical methods to achieve problem resolution. Failure to obtain results or erroneous decisions or recommendations would typically result in serious program delays and considerable expenditure of resources.
Bachelor's degree - Engineering (Mechanical or BioMedical preferred) plus 6+ years of related work experience with a strong understanding of specified functional area, or an equivalent combination of education and work experience. Advanced degreepreferred.
(Technical/Business Knowledge (Job Skills)) Wide application of technical principles, practices, and procedures. Strong understanding of business unit function and cross group dependencies/relationships. Will perform this job in a quality system environment. Failure to adequately perform tasks can result in noncompliance with governmental regulations.
(Cognitive Skills) Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors. Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. Has a sound knowledge of various technical alternatives and their impact.
• Experience with 3D modeling (SolidWorks, ProEngineer)
• Experience developing process and test methods.
• Experience through all phases (from product conception through commercialization) as a member of medical device product development team
• Familiarity with statistical analysis concepts and tools, such as Design of Experiments, Six Sigma
• Experience with medical device standards (QSR, ISO)
• Proven ability to work independently to research and resolve technically issues