Senior Systems Engineer
Delve is looking for an industry-savvy Senior MedTech Systems Engineer to navigate product development within the highly regulated and technically challenging Medical Device industry. Products and technologies vary widely in this sector. We need your collaborative and complementary skillsets along with an eagerness to learn and grow! Our ideal candidate is a change agent, with the vision and adaptability to guide both internal and external team members to success within the ever-changing landscape of patient care. While other team members may phase in and out over the course of the project, the Systems Engineer maintains a steady hand at the helm, from initial scoping through design transfer. Your duties will include the development of high-level strategies along with the execution of technical deliverables. You can zoom in and out of the big picture and create resources that allow others to do the same. As part of a growing competency at Delve, you can articulate the way you work into a set of best practices to support the expansion of our Systems Engineering community of practice.
Responsibilities
Responsible for defining system architecture, architectural decomposition, and allocation of subsystems. This position will be indirectly managing a team of designers, engineers, and technicians to deliver technical content for a project.
Recognize and manage technical project risks as they arise, working with project leadership to prioritize and resolve risks using a data-driven approach. Lead trade-off discussions to balance stakeholder needs related to competing requirements, manufacturability, serviceability, quality, and cost.
Understand and cascade user needs and applicable regulatory and/or commercial standards into customized frameworks supporting system and subsystem requirements and specifications. Establish and maintain the product’s design trace matrix using digital platforms and tools.
Using a combination of leadership skill and systems engineering best practice (eg. interface specifications), supply design inputs to and objectively evaluate the outputs of cross-functional teams (hardware, software, firmware, digital, and industrial design) to ensure design control and conformance.
Work with PM and Quality team members to create and maintain a product development plan. Support the team in achieving program milestones, including the creation and review of product design control artifacts as governed by applicable internal and/or external Quality Management Systems (QMS).
Represent Quality Engineering (Delve and/or Client) stakeholder needs, ensuring that regulatory partners, marketing, healthcare professionals, scientists, designers, and human factors design engineers fulfill all applicable QMS requirements to build a robust Design History File (DHF).
Lead the engineering team in the planning and execution of design verification and design validation. Support Industrial Design and Human Factors Engineering teams in the identification of required feature sets for inclusion in formative and summative studies.
Interact with our valued clients through meetings, presentations, design reviews and informal interactions - building trust and respect through a highly collaborative development process
Requirements
Bachelor's degree in engineering (Mechanical, Electrical, Biomedical or related field)
7+ years’ work experience in the medical device industry, or 5+ years with advanced degree in a related field
Experience supporting the development of FDA-regulated Class II and/or Class III electromechanical devices OR devices with an equivalent level of design control
You’ve spent time in a clinical and/or patient setting
Experience working according to regulated industry standards, such as ISO-13485 and IEC 62304.
Ability to travel up to 10% of the time, domestically
Preferred Experience
You have additional experience in the development of Class I devices and/or non-medical commercial products.
You have supported multi-disciplinary teams in both early and late phases of product development, including manufacturing and design transfer.
You have introductory level experience with model-based systems engineering and have a working knowledge of SysML or comparable modeling tools.
You have experience in a consulting environment with a proven customer-centric attitude and personality and can effectively scope work.
You have experience distinguishing between project and user needs, can formulate strategies, and have led an engineering team through to a successful outcome.
You are a natural collaborator who can effectively facilitate group activities, including in-person and remote work sessions.
You are a convincing presenter and engaging storyteller who is comfortable on stage in front of an audience of clients and peers, whether presenting development plans, design work or offering your expert opinion.
You clearly communicate both visually and verbally with key internal and external project stakeholders to keep them informed of engineering needs, progress, and any potential obstacles.
You are motivated by change and see public health issues, social injustices, and generational differences as meaningful opportunities to adapt how we design and collaborate, and what we deliver.
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.
About Delve
Delve is a multidisciplinary product innovation firm that brings bold ideas to market those guides clients through the complexities of innovation, delivering better, faster, and more sustainable success. For over 55 years, Delve has mobilized the best experts and technologies for its clients, completing over 10,000 client projects, producing over 1,500 patents, and winning over 200 design awards.
Delve serves ambitious start-ups to Fortune 500 clients in the healthcare, consumer, and commercial industries, delivering innovation through advanced expertise in research, strategy, design, and engineering. Delve has placed innovation studios in Boston, Madison, Philadelphia, and San Francisco to attract forward- thinking leaders to solve complex product challenges through human-centered design.