Principal Engineer - Sustaining

Job Description

The Principal Engineer is responsible for performing and/or leading all aspects of Sustaining including technical planning, feasibility studies, device development, investigations and corrective actions, cost reductions, verification, and validation activities. The primary responsibility of the position is the technical maintenance of the Design History File and Technical Files post launch.  He or she must fully understand medical device design control requirements and be able to effectively manage a project and work effectively in a cross functional team. May serve as a core or extended team member on projects. Maintains detailed documentation throughout all phases of research and development.

May provide leadership and direction to Engineering Technicians and mentor less experienced engineers within and across OSTA sites in best practices for the use of engineering tools and methods.

Job Duties

• Provides technical leadership on Sustaining / Systems projects and/or development efforts.
• Accountable for all aspects of product development activities and product Design History File, such as; requirements creation/documentation, ideation / prototyping, design / development, technical risk mitigation, verification testing and reports, design validation studies, risk management documentation, design reviews, and supports the compilation of documents to enable regulatory submissions.
• Develops engineering solutions, investigates competing technologies, and collaborates with Olympus Patent Attorneys to secure a strong IP portfolio
• Directs or performs design analysis, such as tolerance stack-ups, strength of materials, risk analysis, and statistical evaluations.
• Ensures product designs are cost effective, manufacturable, and products are tested through well thought out verification plans to ensure a high degree of product quality and reliability.
• Consults with the Sales, Marketing, and clinicians to define and specify product user requirements.
• Manages, directs and supports suppliers involved in product development and ongoing production.  This includes outside design and/or development/manufacturing partners.
• Helps prepare and acts as a consultant to marketing on technical brochures, training programs, and technical presentations to customers and the sales force
• Drives Design History File remediation efforts and CAPA projects as needed.
• Supports engineering leadership as required.

Job Qualifications

Required:

• Bachelor’s degree in Biomedical, Mechanical Engineering, Electrical Engineering or similar.
• Minimum years of related experience: 9+ years or 8+ years with MS or 5+ with PhD.
• Other Considerations (travel/hours availability, etc.): Travel up to 15%

Preferred:

• Ability to effectively work within a requirements management system.
• Previous experience in design, development, and sustaining of Medical Devices.
• 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.
• Solidworks working knowledge. Proficient in the creation and critical review of engineering drawings including geometric dimensioning and tolerancing and tolerance analysis. 
• 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 (Stat Ease, Minitab are 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 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.