Do you want to be part of a small, talented, and energetic team in a startup environment, with exposure to a Who’s Who of the world’s medical and medical device professionals? Look no further than the Jacobs Institute. Apply via LinkedIn to discover new opportunities as they arise.
The Quality Engineer ensures that our processes, services, and product designs meet client, industry, and regulatory requirements per ISO 13485:2016 and 21 CFR 820. These certifications provide quality assurance to our clients, while fostering medical device innovation.
Why the Jacobs Institute?
The Jacobs Institute (JI) is a non-profit 501(c)(3) organization whose mission is to drive next generation technologies in vascular medicine through the collisions of clinicians, researchers, industry, and entrepreneurs. Our vision is that the Jacobs Institute’s medical innovation improves healthcare outcomes and result in economic development in Western New York.
Working at the Jacobs Institute means you will be able to work with passionate and creative people across a variety of clinical and engineering disciplines. On any given day you will be exposed to opportunities to identify unmet clinical needs and fast track those through the product lifecycle. You will engage with industry, academia, and clinicians as an engineer translating user feedback into ideas and products via our i2R (Idea to Reality) Center prototyping space. You will get to work in an engaging culture creating inspiring, user-centered designs.
Why this role is important at the Jacobs Institute?
As a Quality Engineer here, you ensure that our systems and products meet client and regulatory requirements, providing clients with peace of mind when working with us. This allows us to create product designs and experiences that genuinely impact people’s lives. You’ll be part of strengthening the medical device innovation backbone.
Once you are here you might:
- Apply quality and project management principles throughout design controls and manufacturing processes.
- Lead Quality activities in product and process design, including risk management such as hazard analyses, design and usability FMEAs, and reports.
- Lead Quality activities in product manufacturing, including root cause analysis of identified issues, corrective and preventative actions, non-conformances, and process monitoring and improvement.
- Ensure compliance of all practices to the JI quality system, ISO 13485:2016 and 21 CFR 820 requirements.
- Identify and communicate opportunities for and execute the training of others within the organization and manage associated records.
- Prepare annual quality system management review materials.
- Prepare for and perform annual internal audit activities.
- Manage, communicate, and solicit customer feedback according to requirements within the quality system.
- Manage the organization’s document and change control systems.
- Manage the organization’s equipment listing, coordinate preventative maintenance and calibration activities.
- Prepare and communicate monthly monitoring of quality objectives.
- Manage external suppliers, including supplier qualification, performance monitoring, evaluation, and auditing.
- Use appropriate statistical tools, such as collecting and summarizing data, drawing conclusions with confidence, determining sample sizes, applying data distributions, identifying relationships between variables, design and analyses of experiments with statistical decision making.
- Support regulatory submission and reporting activities.
- Prepare communications in weekly reports, status updates, detailing progress and costs for management.
- Apply critical thinking skills to all tasks and offer solutions to improve processes.
- Collaborate with engineers, physicians, scientists, and researchers.
- Bachelor’s degree in an engineering or science field, MS or PhD preferred.
- 3-5 years of practical experience in the neurovascular, cardiovascular, or related medical device industry or 3+ years’ experience in industry, plus advanced degree.
- Advanced understanding of FDA requirements associated with the development of medical devices (e.g. ISO 13485:2016, 21 CFR 820, Design History Files, Regulatory Strategy – formal training preferred).
- Advanced understanding of Statistical Methods and Project Management Principles (formal training preferred).
- Must perform well individually and in cross-functional, highly dynamic development teams.
- Ability to work in fast paced organization, meeting multiple deadlines, and succeeding under pressure is a must.
To apply, please submit your resume & cover letter to email@example.com. Your portfolio should include at least 2 examples of work-related projects. In particular, we want to hear about the process involved in developing a project. Bonus points if you include 2-3 projects you have worked on for fun.