Job Description

The Sr. R&D Engineer is responsible for assisting and/or leading the development of medical devices employed in various types of endoscopic surgeries. The primary responsibilities of this role include supporting all phases of device development, in particular the identification and evaluation of design options, the definition of product / performance specifications, and design verification and validation activities. Within a collaborative team environment, it will be expected that he or she will be a proactive communicator, collaborate well with others, manage their work efficiently, produce high quality work and consistently seek additional knowledge and skills.
Creation of technical data, data analysis, and subsequent reporting will be an important aspect of this role, as well as helping to generate all documents / deliverables that will comprise the Design History File; therefore a working knowledge of FDA Design Controls is required.

Job Duties

• Provides technical leadership, and/or significant contributions, to product development projects and/or technology development efforts.
• Contributes to all aspects of product development activities and product Design History Files, 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 as needed.
• Supports or leads efforts to evaluate and identify design solutions which will meet product/performance requirements, cost targets, and manufacturability requirements.
• Performs design analysis, such as power budgets, safety margin, memory allocation and MTBF
• Works directly with safety certification organizations to ensure compliance with applicable safety standards.
• Partners with the software developers to ensure electrical design works seamlessly within the software architecture, identifies potential issues, and negotiates trade-offs as required.
• Develops product verification and validation testing strategies, testing protocols and reports, and ensures products meet/exceed established specifications.
• Employs statistical techniques to establish exceptional product quality, reliability, and robustness.
• Supports in ensuring product and performance specifications are appropriate and accurate.
• Supports marketing in the planning and creation of technical brochures, training programs, and technical presentations to customers and the sales force.
• Supports engineering leadership as required.

Job Qualification

Required:

• Bachelor’s degree in electrical engineering.
• Minimum year of related experience: 5+ years or 4+ years with MS or 0-2 years with PhD.

Preferred:

• Experience in Medical Device development and/or sustaining engineering efforts utilizing a stage-gate process. Experience in hand held electro-mechanical devices is preferred.
• Working knowledge of, and experience in applying, FDA Design Controls and international standards (e.g., Design Controls, 820-CFR, ISO14971, ISO10993, IEC60601, GMP, etc.).
• Capable of developing many of the 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.
• Working knowledge of printed circuit board design tools, such as Altium or OrCAD with ability to create and scrutinize Gerber data.
• Knowledge of printed circuit board design and manufacturing processes. Must have expertise in development of schematics, selection of components and have up to date knowledge of developments in the electronics industry.
• Experience planning and mitigating for electromagnetic compatibility.
• Knowledge of common manufacturing methodologies, technologies, and materials employed in medical devices.
• Ability to effectively work within a requirements management system and perform hardware risk analyses and hardware DFMEAs.
• Experience in the practical application of statistics and working knowledge of a statistical analysis package (Minitab).
• Must be able to collaborate effectively with others, works well within cross-functional teams and across multiple sites, as applicable.