Senior Principal Engineer

Job Description

The Senior Principal Engineer is responsible for all Research and Development responsibilities associated with the development of disposable and electromechanical systems from concept development through commercial launch. Technically, this includes conducting and/or collaborating on development strategies, definition and refinement of design inputs, concept development, establishing design merit (i.e., feasibility testing), establishing design verification readiness and planning for production equivalent units, as well as oversight and execution of verification and validation testing, etc. In addition to technical responsibilities, the Senior Principal Engineer will be a technical core team member / technical leader and must provide technical leadership to teams, clearly ideate product solutions and development strategies/plans, and clearly/concisely communicate to functional and executive management. The Senior Principal Engineer must be expert in Design Control, application of applicable standards / regulations, as well as understand the importance of business drivers (cost, schedule, resources).

Job Duties

• Provides clear and decisive technical leadership on complex product development projects and/or technology development efforts.
• Capable of quickly developing high-level product development strategies for complex programs, which present various critical interfaces and contingencies, with clear logic, thoroughness, and attention to detail.
• Collaborates effectively cross-functionally on all product development activities and deliverables, and can negotiate with respect and report.
• Clearly and concisely updates functional and senior leadership to project advancements and/or issues with appropriate consideration of the audience to instill trust and confidence.
• Conscientious to the impact of decisions, issues, etc. to the wider Olympus organization and acts accordingly to ensure shared knowledge and seeks input when appropriate.
• Proactively generates or seeks appropriate data and/or information to quickly make project / design decisions.
• Ensure product designs are cost effective, designed for manufacturability, and exhibit a high degree of quality and reliability via well thought out [and executed] feasibility and verification test plans
• Develops presentations and/or communication tools to effectively communicate complex topics to technical and non-technical team members and leaders.
• Foresees technical hurdles and risks and implements contingency plans or actions well in advance of realizing project / product delays or issues.
• Drives all efforts forward quickly and efficiently.
• Seeks continuous improvement of our systems and processes.
• Exhibits a high degree of technical expertise in product design & development.
• All Other Essential Duties as directed

Job Qualifications

Required:

• Bachelor’s degree in Engineering or the equivalent in years of industry experience.
• Minimum years of related experience preferred: 14 years with BS or 10 with MS or 8 with PhD.
• Experience working with external development partners while maintaining DHF ownership.
• Experience leading technical efforts as Technical Core Team Member (i.e., Core Team Model experience).
• Must have extensive working knowledge of, and experience in applying / developing products in compliance with FDA and international requirements, including 820-CFR, ISO14971, IEC60601, GMP and other standards as they relate to the design and manufacture of medical devices.
• Proficient in Microsoft Windows Office applications including MS Outlook, MS Powerpoint, MS Project, Visio, etc.
• Knowledge of common manufacturing methodologies, technologies, and materials, such as; injection molded part design, common materials employed in medical devices, and other manufacturing processes.
• Must be able to solve complex and/or ambiguous problems using good judgement as well as logical and systematic thinking. Capable of providing problem solving guidance to other engineers.
• Must be able to use good judgement in making timely decisions. Able to balance risk vs. benefits in a variety of situations.
• Experience in the practical application of statistics and working knowledge of a statistical analysis package (Minitab preferred).

Preferred:

• Experience / Knowledge of disposable scope systems and technologies highly preferred.
• Must be able to collaborate effectively with others, work well within cross-functional teams and across multiple sites, as applicable.
• Must be able to manage resources and drive for results.
• Must be able to communicate effectively at all levels, both verbally and in writing. Strong presentation skills and the ability influence. Inspires and motivates others and provides work direction.

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