As a Quality Engineer, you will play critical role in ensuring our multi-disciplinary teams abide by our quality standards as we create meaningful solutions to product design challenges. An ideal candidate is comfortable with both the big picture and the details, and excited about the opportunity to help Delve continue to grow. This is a hybrid position, with a preference for a candidate in commuting distance to our Madison office.
Primary Responsibilities :
- Shepherd the development teams through creation of Design History File documentation, ensuring best practices for both templating and content development.
- Facilitate design reviews and other collaborative sessions such as design Failure Modes and Effects Analysis (dFMEA) sessions and Hazard Analysis (HA) sessions.
- Mentor and guide the technical teams through best practices for crafting user needs and design inputs in such a way that appropriately streamlines the downstream verification and validation activities.
- Manage requirements traceability ensuring proper documentation of user needs, design inputs, design outputs, verification and validation per ISO 13485 and FDA 21 CFR 820.30 standards.
- Manage risk documentation to ensure proper documentation and mitigation of risks per ISO 14871.
- Review product and software specifications to ensure they are verifiable and properly translated to testing protocols
- Support the ongoing development of Delves Quality Management System (QMS), including written procedures, work instructions and templates to meet ISO 13485 standards.
- Represent quality considerations within multi-disciplinary development teams and providing situational leadership to help drive projects to success
- Interact with our valued clients through meetings, presentations, design reviews and informal interactions - building trust and respect through a highly collaborative development process
- Have fun, doing cool work with good people and helping us support and grow our culture
- Bachelors degree in related engineering or technical field
- 5 years' intermediate level experience in medical device development
- Experience executing projects under ISO 14971, FDA 21 CFR 820.30, ISO 13485, IEC 62366, etc.
- Experience with IEC 62304 and the creation and execution of software verification and validation protocols and reports.
- You have a customer-centric attitude and personality
- You have exceptional oral and written communication skills with the ability to thoughtfully articulate and present technical ideas in formal and informal settings.
- You are able to work under general direction to independently determine and execute on best approach to fulfilling daily responsibilities.
- You are highly motivated, self-starter, able to manage multiple priorities.
- You act with an inclusive mindset and model these behaviors for the organization.
- You are motivated by change, and see the pandemic, social injustice, and our younger generations as meaningful opportunities to adapt how we design and collaborate, and what we deliver. Because equity, inclusion, and diversity are important to you, you have a point of view, personal or professional experience, or interest in helping make a difference.
Be inspired. Be inspiring. Be yourself.
Delve embraces difference because creativity, curiosity, and diversity drive innovation. We nurture a supportive and inclusive environment. Be yourself and create a future that improves lives. We encourage applicants of color and those with diverse lived experiences to apply.