Manager of Public Policy Operations driving policy events and outputs at CSA. Overseeing project managers and ensuring high - quality deliverables aligned with organizational strategy.
About the role
- Senior Design Transfer Engineer at Sword Health ensuring efficient transitions from product development to manufacturing. Collaborating with cross-functional teams to support production readiness and mitigate design risks.
Responsibilities
- 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.
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 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.
Benefits
- Health, dental and vision insurance
- Meal allowance
- Equity shares
- Remote work allowance
- Flexible working hours
- Work from home
- Discretionary vacation
- Snacks and beverages
- English class
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