Director of Engineering

Transcend is a fast-growing, Twin Cities–based medical device company transforming the way people experience sleep therapy. Our flagship travel-friendly CPAP device—compact enough to fit in the palm of your hand—and our expanding accessory and software ecosystem help people sleep better, travel easier, and live more fully—wherever their journey takes them. We are seeking a hands‑on Director of Engineering who will personally lead new product programs, act as the program owner for development from concept through launch and help shape Transcend’s long-term technology strategy as a member of the senior leadership team.

As Director of Engineering at Transcend, you will be the driving force behind the design, development, and delivery of our sleep and respiratory health technologies—from core CPAP platforms to accessories, software, and adjacent consumer products.

This role blends strategy and execution. You will set technical direction, develop a high‑performing team, and personally drive new product development programs from concept through launch. You will serve as the program owner and de facto project manager for new product development, responsible for aligning engineering, QA/RA, operations, supply chain, marketing, and external partners around clear plans, milestones, budgets, and risk mitigation strategies.

You will directly manage external engineering consultants and contract manufacturers as a key part of NPD execution. You will report to the CEO and be part of the senior leadership team.

• Set technical strategy and engineering priorities aligned with company goals
• Contribute to product roadmap development and company‑wide strategic planning
• Build, develop, and retain a high‑impact engineering team
• Foster a culture of accountability, rigor, and innovation

• Lead NPD efforts across the full lifecycle—from ideation and architecture through development, verification, validation, launch, and post‑market support—with direct personal involvement in technical execution
• Act as program manager for major development initiatives, owning schedules, resources, budgets, and deliverables
• Manage and critically evaluate external engineering consultants and contract manufacturers; hold them accountable to deliverables within the design control process
• Qualify new component and contract manufacturing suppliers; own the technical side of those relationships
• Establish clear phase‑gate processes, design reviews, and executive readouts
• Drive systems‑engineering approaches across hardware, firmware, software, and accessories
• Guide feasibility studies, design concepts, and technology trade‑offs

• Ensure robust design controls and compliance with FDA QSR, ISO 13485, and applicable global standards
• Personally author or co‑author key design control deliverables: requirements, risk files, V&V protocols, and DHF content
• Anticipate technical and regulatory risks and lead mitigation strategies
• Support manufacturability, cost‑down initiatives, and supplier collaboration
• Develop and protect intellectual property
• Oversee documentation, DHFs, and engineering change processes

• Partner closely with QA/RA, operations, supply chain, marketing, and commercial teams
• Serve as a visible leader in a fast‑paced, resource‑constrained environment

• Bachelor’s degree in engineering or related discipline required; advanced degree preferred

• 10+ years of engineering experience in medical devices or regulated products, preferably Class II, with demonstrated recent hands‑on involvement in technical execution—not only oversight of others
• Proven success leading cross‑functional product launches in a regulated environment
• Experience with 510(k) submissions as a primary engineering contributor, not solely a reviewer
• Experience managing external engineering consultants and contract manufacturers as part of NPD programs
• Experience in high‑growth, entrepreneurial, or small‑company environments strongly preferred

• Deep understanding of FDA regulations,…