Senior Design Engineer

3 weeks ago

Bengaluru, Karnataka, India Halma plc Full time
About Halma plc

Halma plc is a global group of life-saving technologies companies, driven by a clear purpose. We are a FTSE 100 company with headquarters in the UK and operations in 23 countries, including regional hubs in India, China, Brazil, and the US.

Our diverse group of nearly 50 global companies specialize in market leading technologies that push the boundaries of science and technology.

We have a team of over 250 professionals representing commercial, digital and support functions across our seven offices in India, two in Bengaluru and one each in Delhi, Mumbai, Thanjavur, Ahmedabad and Vadodara.

Why Work with Us?

We offer a safe and respectful workplace, where everyone can be who they are, feel free to bring their whole selves to work and use their unique talents, knowledge, expertise, experiences, and backgrounds to create meaningful outcomes.

We nurture entrepreneurial spirits and empower them to think beyond the possibilities, to discover, shape and build their own unique stories. We promote and support non-linear career growth for the right talent.

We are simple, humble and approachable, and we believe in leadership at all levels to bring our purpose to life. Everyone at Halma plc makes an impact, and so do you when you join us.

About MST

MST's passion is creating exceptional surgical devices and instruments used to restore or improve sight for patients all over the world. It is our relentless pursuit of addressing our customers' needs that creates a profound customer preference. We strive to equip surgeons with the most innovative tools, enabling them to achieve the best possible outcomes for the patients.

We constantly evolve to meet the distinct clinical needs of ophthalmic surgeons through our dedicated partnership with surgeon-designers, bringing innovation to ophthalmology. Expanding our offerings into excisional goniotomy, we now market micro-instruments used for adult and infantile glaucoma, which improve the health and livelihood of patients by providing a safe and effective surgical intervention.

Key Responsibilities
  • Review existing design files and utilize engineering knowledge and experience to assemble design requirements
  • Review and reference appropriate design outputs, identify key characteristics and critical dimensions
  • Identify risk controls and insert links between risk assessment and design requirements
  • Create design verification plans and reports
  • Effectively collaborate and communicate with cross-functional team members
Experience
  • 5 to 7 years of experience in medical device or other highly regulated industry
  • Experience with writing design requirements or verification plans
  • Experience with SolidWorks 3D models, drawings, and PDM system
  • Experience with EU MDR technical file creation or support
Critical Success Factors
  • Experience in working with medical device design controls and quality management system
  • Experience with EU MDR technical file creation or support
  • Experience with materials and biological safety testing, familiarity with ISO 10993
  • Experience with usability engineering for medical devices, familiarity with IEC 62366
  • Experience in packaging validation of medical devices
  • Experience in applying statistical analysis to verification testing
Academic Qualification
  • BE / MTech in Mechanical or Biomedical Engineering

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