Systems Engineer

As a Systems Engineer you will help lead the holistic design, development, testing and system integration efforts for a broad range of products, with a focus on supporting medical device development.  Additional responsibilities would include supporting development and maintenance of our Design Control SOPs

The ideal candidate would live in proximity to one of our 4 studio locations, but we will consider remote candidates who are open to occasional travel.

Responsibilities

• Drive the design requirements for the product (often in collaboration with clients) while balancing implementation complexity, technical risks, manufacturability, serviceability, quality and cost.
• Understand and capture the user needs into system requirements and responsible for the architectural decomposition and allocation to subsystems. This position will be managing an indirect team of designers, engineers, and technicians to deliver technical content for a project.
• Develop the strategy and plan to achieve key program milestones adhering to governing Design Controls
• Ensure that technical risks are retired as they arise on the program.
• Collaborate with Quality Engineering (Delve and/or Client) to ensure Design Control requirements are fulfilled to build a robust Design History File (DHF).
• Ensure compliance with relevant regulations and standards throughout the development process.
• Lead the engineering team in the planning and execution of verification and validation.
• 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 medical device electromechanical product development.
• Proven track record in medical device development with a strong understanding of ISO-13485, IEC 62304, ISO 14971 and IEC 60601.

Preferred Experience

• You have experience in a consulting environment preferred with a proven customer-centric attitude and personality.
• You understand project needs, formulate a strategy, and lead the engineering team through 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 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 meaningful opportunities to adapt how we design and collaborate, and what we deliver. You have a point of view on equity, inclusion, and diversity, and have an interest in striving for positive progress in this area.

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.