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Senior Design Transfer Engineer - Systems Operations Engineering

2 hours, 50 minutes ago
Portugal
Full-time
Senior
QA Engineer
Quality Assurance and Testing
Apply Now
SWORD Health

SWORD Health

SWORD Health provides AI-powered digital physical therapy solutions designed to prevent pain, support recovery, and enhance overall health, while also aiming to transform the rehabilitation industry through innovative technology and clinical oversight.

Health Care Providers & Services
251-1K
Founded 2015
$324M raised
View All Jobs 16

Description

  • Execute design transfer activities from NPI through EVT/DVT, pilot builds, and ramp-up to ensure products 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 before 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.
  • Analyze early manufacturing data from pilot and ramp-up phases to identify design-related risks and inform process optimization.
  • Participate in technical investigations during early production using root cause analysis methods such as 8D, 5 Why, and FMEA.
  • Provide technical input to Engineering Change Orders that affect manufacturing readiness and early production.
  • Verify the effectiveness of design-related corrective actions during early production before handoff.

Requirements

  • Bachelor’s or Master’s degree in Mechanical, Industrial, Biomedical Engineering, or a related field.
  • 5+ years of experience in regulated manufacturing environments with exposure to design transfer, industrialization, or manufacturing engineering.
  • Hands-on experience supporting EVT/DVT builds, pilot runs, and production ramp-ups.
  • Strong understanding of manufacturing processes, production systems, and quality controls.
  • Experience applying root cause analysis tools such as 8D, 5 Why, and FMEA in manufacturing or industrialization contexts.
  • Familiarity with medical device quality systems and change control processes, including ISO 13485 and 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 such as SPC and capability analysis, along with basic data visualization.
  • Experience in fast-paced, high-growth product development environments.
  • Ability to leverage data analytics and AI-assisted tools to improve design transfer execution, documentation support, datasheet and specification review, QMS alignment, and early identification of manufacturability and ramp-up risks.

Benefits

  • Competitive salary of €42,000–€66,000 a year, including base, variable pay, and equity.
  • Health, dental, and vision insurance.
  • Equity shares.
  • Remote work allowance and work-from-home support.
  • Flexible working hours with unlimited vacation/discretionary vacation.
  • Access to a health and well-being program, including digital therapist sessions.
  • Meal allowance, snacks, and beverages.
  • English classes.

Interested in this position?

Apply directly on the company website

Apply Now

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