Job Description

The Principal Engineer is responsible for performing and/or leading all aspects of product development, including technical planning and development strategy development, development of design inputs, and directing/supporting verification and validation efforts. In particular, it will be the responsibility of the Principal Engineer to ensure well defined product and performance specifications for the system are defined and tested to ensure all efforts are completed on schedule, while proactively mitigating potential issues, to enable the timely launch of high quality / reliable products. He or she must fully understand medical device design control requirements and be able to provide effective technical leadership to product development efforts and team members, negotiate strategies with cross-functional leaders, and work collaboratively across the organization. The Principal Engineer will serve as a core or extended team member on development projects. As the Principal Engineer will heavily contribute to Design History Files, maintaining detailed documentation throughout all phases of research and development is essential.

The Principal Engineer will 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 as needed.

Job Duties

• Provides technical leadership on product development projects and/or technology 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
• Ideates, evaluates, and directs team towards design solutions which will meet product/performance requirements, cost targets, and manufacturability requirements.
• Accountable for the development of effective/efficient product verification and validation testing strategies, testing protocols and reports, and ensures products meets/exceed established specifications.
• Employs statistical techniques to establish exceptional product quality, reliability, and robustness.
• Consults with the Sales, Marketing, and clinicians to define and specify product user requirements and ensures product and performance specifications are appropriate and accurate.
• Manages, directs and supports internal and external suppliers and manufacturers as needed. Including external design and/or development partners.
• Helps prepare and supports marketing on, technical brochures, training programs, and technical presentations to customers and the sales force.
• Supports engineering leadership as required.
• All additional duties as directed.

Job Qualification

Required:

• Bachelor’s degree in engineering required.
• Minimum years of related experience: 9+ years or 8+ years with MS or 5+ with PhD

Preferred:

• Established track record of leading Medical Device development and/or sustaining engineering efforts utilizing a stage-gate process.
• Experience / Knowledge of single use scope systems and technologies highly preferred.
• 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 development and manufacture of medical devices.
• Capable of developing all deliverables required to document the product design with appropriate specificity to enable high volume manufacturing with high quality.
• Proficient in Microsoft Windows Office applications including MS Outlook, MS PowerPoint, MS Project, Visio, etc..
• Solidworks working knowledge. Proficient in the creation and critical review of engineering drawings, tolerancing and tolerance analysis.
• Knowledge of common manufacturing methodologies, technologies, and materials employed in medical devices.
• Ability to communicate complex technical concepts clearly and concisely is required.
• Ability to effectively work within a requirements management system (e.g., JAMA, Doors) preferred.
• Experience in the practical application of statistics and working knowledge of a statistical analysis package (Minitab).
• Must be able to collaborate effectively with others, work well within cross-functional teams and across multiple sites, as applicable.