Senior Sustaining R&D Engineer
Website Olympus Corporation of the Americas
In order to be considered, applicants must apply through our website: https://careers.olympusamerica.com/job/Westborough-Senior-Sustaining-R&D-Engineer-MA-01581/793251500/?locale=en_US
The Sr. 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.
* Provides leadership to sustaining/product development projects and/or technology development efforts.
* Contributes to 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 as needed.
* Supports or leads efforts to evaluate and identify design solutions which meet product/performance requirements, cost targets, and manufacturability requirements.
* Develops product verification 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 internal and external suppliers and manufacturers as needed. Including external design and/or development partners.
* Supports Design History File remediation efforts and CAPA projects as needed.
* Supports engineering leadership as required.
* Bachelor’s degree in Biomedical, Mechanical Engineering or similar.
* Minimum of 5 years of related experience; or 4 years with Master’s degree, or 0-2 years with PhD.
* 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..
* 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.
* Experience in the practical application of statistics and working knowledge of a statistical analysis package (Minitab).
* Must be capable to effectively executing on multiple work streams in parallel.
* Must be able to communicate effectively, both verbally and in writing. Comfortable presenting information to team members and stakeholders.
* Must be able to work in a professional open-space environment without distracting others.
To apply for this job email your details to firstname.lastname@example.org