Mechanical Design Engineer (Medical Devices)

Location: Stockholm; hybrid

Company

hirify.global develops proprietary, non-invasive healthcare technology and combines it with direct clinical care to deliver personalised, actionable preventative-health insights.

What you will do

• Determine what must be proven before mechanical designs are released and devise fast, practical ways to evaluate the risks.
• Design and build prototypes, test setups, measurements, and trials covering function, dimensional behaviour, robustness, and subsystem integration.
• Assess manufacturability and assemblability with design engineers and manufacturing stakeholders, using in-house workshops, machine shops, printers, suppliers, and manufacturers.
• Develop design-readiness practices by applying lessons from previous products and shortening the loop from design questions to answers.
• Work with production engineering on manufacturing issues, correct CAD and drawings, and move design changes through release without delaying production.
• Own or support the mechanical design of products as appropriate, working within design control and medical-device change processes.

Requirements

• Mechanical design and CAD depth demonstrated on products taken from design into production.
• Hands-on build and rapid-prototyping experience, including time spent on a production floor close to how products are built and assembled.
• Practical experience applying design for manufacturing and design for assembly.
• Experience devising and running practical tests and judging what should be tested and when.
• Fluency in drawings, tolerancing, and tolerance stack-up.
• Comfort working within controlled release and engineering change processes, including medical-device change control where applicable.
• Self-directed approach: identify risks, set the agenda, and pursue mitigations without needing detailed direction.
• Ability to work with manufacturing and sourcing, receive critical design feedback, and act on it.
• Experience with regulated products, medical devices, or another regulated industry; familiarity with ISO 13485 or EU MDR design control.

Culture & Benefits

• Work in a five-person mechanical design group as its sixth engineer, alongside manufacturing, procurement, electronics, firmware, optics, and verification specialists.
• Operate in small teams where hardware moves quickly between development and production and priorities can change with product needs.
• Work directly with production and see design changes reach physical products and clinical environments quickly.
• Work in a hybrid setup in Stockholm.