Director of Engineering

Transcend; Fridley (MN); On-site; USD 160,000 - 210,000; Full time

Job summary

A medical device company based in Fridley, MN, is seeking a hands-on Director of Engineering. This role involves leading new product programs, managing engineering teams, and ensuring compliance with FDA regulations. The Director will collaborate with various departments to drive product development from concept through launch. Candidates should have over 10 years of experience in medical devices, strong technical background, and proven success in product launches. The position offers a competitive salary and is full-time on-site.

Qualifications

• 10+ years of engineering experience in medical devices or regulated products.
• Proven success leading cross-functional product launches.
• Experience with 510(k) submissions.

Responsibilities

• Drive new product development programs from concept to launch.
• Set technical strategy and engineering priorities.
• Lead efforts across the full lifecycle of new product development.

Skills

Deep understanding of FDA regulations

Strong stakeholder-management skills

Ability to manage complex multi-disciplinary programs

Education

Bachelor’s degree in engineering or related discipline

Tools

Design controls

Risk management (ISO 14971)

Job description

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.

Key Responsibilities

Strategy & Engineering Leadership

• 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

New Product Development & Program Ownership

• 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

Execution, Compliance & Risk Management

• 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

Cross‑Functional Collaboration

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

Qualifications

Education

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

Experience

• 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

Knowledge, Skills & Abilities

• Deep understanding of FDA regulations, ISO 13485, design controls, and risk management (ISO 14971)
• Demonstrated ability to manage electromechanical and software‑connected products across the full product lifecycle
• Ability to manage complex multi‑disciplinary programs with urgency and discipline
• Strong communication and stakeholder‑management skills
• Track record of delivering products on time and to cost
• Product‑minded engineer who balances user experience, quality, and commercial realities

Who Thrives at Transcend

We design medical‑grade products that feel like consumer electronics. Our Director of Engineering is business‑minded, pragmatic, and energized by building things that didn’t exist yesterday.

You’ll succeed here if you:

• Love owning product programs end‑to‑end—and doing a meaningful share of the technical work yourself
• Thrive in a small, fast‑moving environment where you’re building processes, not inheriting them
• Think like a product owner, not just a functional leader
• Believe beautiful design and regulatory rigor should coexist
• Are excited about having a seat at the leadership table

Why Join Us

At Transcend, your work directly improves people’s lives. You’ll join a collaborative leadership team, shape our technology roadmap, and help define the future of travel‑friendly sleep therapy.

How to Apply

This is a full‑time, on‑site role in our Fridley, MN office. Compensation range: $160,000–$210,000 depending on qualifications and experience. Qualified candidates should submit a resume and cover letter to [e-mail]. Transcend Inc. is an equal opportunity employer.