Delve

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   Requirements:  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.   Preferred Qualifications  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.

As a Hardware Manager, you will be a functional and strategic leader, managing a team of experienced and self-motivated electrical engineers. You will provide a balance between empowerment and direction, guiding the teams career development while also guiding them as they solve complex technical challenges. You will work alongside our electrical engineering management team to contribute to and lead the department. You're excited about the opportunity to motivate and energize electrical engineers, and to enable the creation of quality deliverables for our clients. We are looking to fill 2 positions, 1 in Madison and 1 in Philadelphia.    Primary Responsibilities  If the responsibilities below are a good match with your skills and career path, we'd love to talk with you! Inspire and mentor the Electrical Engineering team. Establish goals and provide feedback to engineers so they can grow professionally and guide them in plotting career growth. Leverage your electrical engineering skill and passion on projects, supporting Electrical Engineering project work as technical lead, project manager, and individual contributor. Champion engineering best practices and training, working with the electrical engineering leadership on creation, documentation, and implementation. Supports creating project plans and writing sales proposals while building a client relationships and networks in support of business development. Support the interview process as we recruit and pursue world-class electrical engineering talent Actively participate in planning meetings to maintain team member utilization and try to level work over time Requirements  Bachelor's degree in Electrical Engineering or similar (advanced degrees are a plus). 8+ years of electrical engineering experience, primarily in product development. 2+ years of experience leading electrical engineers in project work or otherwise managing teams of engineers. You have worked in consultancies and are familiar with how they operate. Preferred Qualifications  You have a true passion for electrical engineering and product development, as evidenced by your career and education choices, and enjoy applying your skills and creativity to challenging design problems. You are familiar with every stage of the product development process, are a strong electrical engineer and designer, and have demonstrated experience and expertise with a variety of manufacturing processes, regulatory certification, and PCB development. You have a track record of successfully managing some portion of complex product development projects. You demonstrate high standards of artisanship and attention to detail and can help define/improve department processes and best practices. You are curious, enjoy growing your skills, and are eager to learn new techniques and technologies. You have a deep understanding of electrical engineering methods, processes, and tools, and you are ready to take the initiative to improve them. You have demonstrated a strong track record of leading clients through the full product development process, from brainstorming and conception, through release for production. This should include both technical leadership and project management. You are comfortable with ambiguity and complexity, because you know that sometimes that leads to the most unique, unexpected design solutions. You are confident in your leadership abilities to influence and motivate engineering teams. You have excellent writing, presentation, and interpersonal skills all needed for frequent client interactions and effective leadership. 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.

Delve is looking for a creative and quality focused Principal Embedded Software Engineer with a focus on medical devices to join our team!  The Electrical and Software Engineering team at Delve plays an integral role in all stages of the product development process.   Responsibilities  Developing innovative product concepts through the application of software engineering processes. Translating user needs into defined product specifications Generating and documenting software architecture and detailed design documentation Developing software applications for medical devices adhering to the Delve QMS inclusive of IEC 62304 Developing, supporting, and maintaining software and firmware applications based upon the needs of our clients Creating intuitive, testable, maintainable, and efficient code Commenting and documenting code to ensure maintainability Facilitating and contributing to code reviews Representing software engineering considerations within our multi-disciplinary development teams and providing situational leadership to help drive projects to technical and business success Providing insights into emerging technologies and uncovering, identifying, and creating business and product opportunities for our clients during strategic conceptualization efforts Guiding design teams and our clients through the concept selection decision making processes to ensure that technical considerations factor into alternative narrowing and selection Interacting with our valued clients through meetings, presentations, design reviews and informal interactions - building trust and respect through a highly collaborative development process Creative conceptualizer with ability to effectively envision and communicate concept Having fun, doing cool work with good people and helping us support and grow our culture Requirements  Bachelor's degree in computer science, computer engineering or electrical engineering  10+ years proven track record in firmware or software engineering Proven track record in medical device development with a strong understanding of the intricacies of IEC 62304 Experience with embedded Linux or other Linux variants Experience with FDA and IEC 62304 software classification Experience with several of the following: C, C++, C#, Java, Python Experience using and designing software with one or more of these communications protocols: Ethernet, IP, TCP/UDP, SPI, I2C, Wi-Fi, Bluetooth and other wireless protocols   Preferred Qualifications Experience with GUI software development preferred (experience with QT or React Native frameworks preferred) Experience with source code version control and issue tracking (e.g. Git and Jira) Experience utilizing Agile Development Methodologies Experience integrating with third-party libraries, frameworks, and APIs Experience in a consulting environment preferred with a proven customer-centric attitude and personality   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.  

Job Responsibilities  Perform electrical design and embedded firmware development Conduct Schematic capture and PCB design using Altium and perform simulations with SPICE Develop embedded systems programming in C/C++/C# to implement code for the Internet of Things Connected devices. Provide insights into emerging technologies and uncover, identify and create business and product opportunities for our clients during strategic conceptualization efforts Translate user needs into defined product specifications Develop innovative product concepts through a process of collaborative brainstorming and verifying feasibility with a combination of analytical tools and physical modeling Guide design teams and our clients through the concept selection decision making processes to ensure that technical considerations factor into alternative narrowing and selection Represent electrical engineering considerations within multi-disciplinary development teams and providing situational leadership to help drive projects to technical and business success Interact with our valued clients through meetings, presentations, design reviews and informal interactions - building trust and respect through a highly collaborative development process Create and foster key relationships with strategic clients, becoming a trusted advisor for their product development initiatives.   Requirements BSEE or MSEE (preferred) with 7+ years proven track record in embedded system product development. Experience in PCB development (schematic capture, layout) Experience in software/firmware development with one or more languages (C/C++ preferred) Experience in IoT development from both a hardware and software perspective Experience with regulatory certification of products Experience with variety of high and low volume manufacturing processes and effectively transitioning designs into production Located and authorized to work in the United States. We are unable to offer visa sponsorship at this time. Preferred Qualifications Experience in a consulting environment with a proven customer-centric attitude and personality Proven track record in medical device development with a strong understanding of the intricacies of IEC 60601 Detail-oriented with demonstrated knowledge of creating product documentation (i.e. theory of operation, requirements, test plans) Exceptional oral and written communication skills with the ability to thoughtfully articulate and present technical ideas in formal and informal settings. Highly motivated, self-starter, able to manage multiple priorities. 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.