Senior Design Transfer Engineer - Systems Operations Engineering

Sword Health is shifting healthcare from human-first to AI-first through its AI Care platform, making world-class healthcare available anytime, anywhere, while significantly reducing costs for payers, self-insured employers, national health systems, and other healthcare organizations. Sword began by reinventing pain care with AI at its core, and has since expanded into women’s health, movement health, and more recently mental health. Since 2020, more than 700,000 members across three continents have completed 10 million AI sessions, helping Sword's 1,000+ enterprise clients avoid over $1 billion in unnecessary healthcare costs. Backed by 42 clinical studies and over 44 patents, Sword Health has raised more than $500 million from leading investors, including Khosla Ventures, General Catalyst, Transformation Capital, and Founders Fund. Learn more at www.swordhealth.com. The Senior Design Transfer Engineer – Systems Operations is responsible for executing robust and efficient transitions from product development into manufacturing. This role ensures that product designs are manufacturable, scalable, and production-ready, acting as a key technical bridge between Product Engineering, Process Engineering, Manufacturing Operations, and Quality. Sitting within R&S, this position focuses on influencing design decisions early, preventing manufacturing risks, and supporting production readiness from NPI through EVT/DVT, pilot builds, and ramp-up. The role operates within the design transfer and continuous improvement framework defined by the department, executing priorities and escalating technical decisions as needed. The Systems Operations team sits within Research & Systems and is responsible for bridging product development and manufacturing execution across Sword’s hardware portfolio.The team focuses on design transfer, industrialization, manufacturing readiness, and early production stabilization, ensuring that product designs are scalable, manufacturable, and robust before and during ramp-up.Working cross-functionally with Product Engineering, Process Development, Supply Chain, Quality, and Contract Manufacturers, the team plays a critical role in preventing manufacturing risks early and enabling sustainable scale.As the organization grows, the team is expected to strengthen its impact across design transfer and continuous improvement, leveraging learnings from NPI and ramp-up to enhance manufacturing robustness and long-term performance. What you’ll be doing:

Execute design transfer activities from NPI through EVT/DVT, pilot builds, and ramp-up, ensuring designs are manufacturable, scalable, and production-ready.

Develop and maintain design transfer documentation, including drawings, specifications, BOMs, and manufacturing requirements.

Support production readiness reviews by identifying design-related risks and gaps prior to commercial release.

Partner with Product Engineering to provide manufacturing-driven input into design decisions during development.

Serve as a technical interface with Contract Manufacturers during design transfer and early production phases.

Support early manufacturing data analysis during pilot and ramp-up phases to identify design-related risks and inform downstream process optimization.

Participate in structured technical investigations during early production using root cause analysis methodologies (8D, 5 Why, FMEA).

Provide technical input to Engineering Change Orders (ECOs) impacting manufacturing readiness and early production.

Verify the effectiveness of design-related corrective actions during early production phases prior to handoff.

What you need to have:

Bachelor’s or Master’s degree in Mechanical, Industrial, Biomedical Engineering, or a related field.

5+ years of experience in regulated manufacturing environments, with strong exposure to design transfer, industrialization, or manufacturing engineering.

Proven hands-on experience supporting EVT/DVT builds, pilot runs, and production ramp-ups.

Strong understanding of manufacturing processes, production systems, and quality controls.

Solid experience applying root cause analysis tools (8D, 5 Why, FMEA) in manufacturing or industrialization contexts.

Familiarity with medical device quality systems and change control processes (ISO 13485, FDA 21 CFR 820).

Ability to work cross-functionally and influence technical decisions without direct authority.

Strong technical documentation and communication skills.

Experience with Design for Manufacturability (DFM) and Design for Assembly (DFA) principles.

Exposure to scaling products from pilot to high-volume manufacturing.

Experience working directly with Contract Manufacturers and global supply chains.

Familiarity with statistical tools (SPC, capability analysis) and basic data visualization.

Experience in fast-paced, high-growth product development environments.

To ensure you feel good solving a big Human problem, we offer:

A stimulating, fast-paced environment with lots of room for creativity.

A bright future at a promising high-tech startup company.

Career development and growth, with a competitive salary.

The opportunity to work with a talented team and to add real value to an innovative solution with the potential to change the future of healthcare.

A flexible environment where you can control your hours (remotely) with unlimited vacation.

Access to our health and well-being program (digital therapist sessions).

Remote or Hybrid work policy.

To get to know more about our Tech Stack, check here.