Device Assembly Process Engineer

Trzdev7

$79,336.80 - $119,005.20 usd annual; bonus/equity:...
Device/combination product assembly technical leadership
Assembly process characterization
Medical device/combination product design transfer
Support assembly process development for medical devices and/or combination products, including accessorized prefilled syringes and auto-injectors

Job Summary

  • Support assembly process development for medical devices and/or combination products, including accessorized prefilled syringes and auto-injectors.
  • Provide technical leadership in a fill-finish/assembly pilot laboratory, develop risk assessment tools, and maintain groundbreaking technical knowledge.
  • Assist or lead design transfer of assembly processes to CMOs and internal facilities, managing timelines and multi-functional teams.

Matching Summary

Support assembly process development for medical devices and/or combination products, including accessorized prefilled syringes and auto-injectors.

Salary

$79,336.80 - $119,005.20 USD Annual; Bonus/Equity: Short-term incentive bonus opportunity, potential equity; Benefits: 401(k), paid vacation, holidays, leaves, health benefits

Skills & Requirements

Must-have

  • Device/Combination Product Assembly Technical Leadership
  • Assembly Process Characterization
  • Medical Device/Combination Product Design Transfer
  • Risk assessment tools and study protocols
  • Experimental design and data analysis
  • cGMP regulations for combination products

Nice-to-have

  • Injection molding and materials science
  • Self-motivation and technical rigor
  • Groundbreaking technical knowledge
  • Unexpected teamworks

Key Requirements

  • Bachelors degree and 5+ years OR Masters degree and 2+ years experience
  • Mechanical Engineering, Biomedical or related field
  • Med device or combination product experience
  • Design Transfer experience
  • Experience organizing and leading multi-functional teams

Work Rights

Not specified

Tailored Resume

Cover Letter