Product Development Engineer

24 hours ago


Bloomington MN USA, United States Saluda Medical Full time
Job Title: NPI Engineer

At Saluda Medical, we're revolutionizing the standard of care in the neuromodulation space by transforming the lives of patients suffering from debilitating pain. We're seeking an experienced NPI Engineer to support the introduction of new products by providing technical expertise to contract manufacturing programs executing product launches and transfers.

Key Responsibilities:
  • Support new product introductions and collaborate with contract manufacturers to ensure successful transfer to production
  • Foster strong working relationships with manufacturing partners and internal team members to optimize productivity
  • Perform, document, and review engineering activities such as design verification, process validation, and engineering changes
  • Execute and drive execution of deliverables to support the Product Development Lifecycle
  • Contribute to ongoing improvement of Saluda's Quality Management System
  • Up to 25% travel required
Requirements:
  • 7 years of engineering experience with a minimum of 5 years' experience supporting development of medical device design and manufacturing
  • Proven collaboration skills with external supply chain partners
  • Excellent written and verbal communication skills to clearly explain change and risk
  • Mindset to get things done in an emerging company
  • Bachelor's degree in Engineering (or equivalently relevant field)
  • Demonstrated ability to liaise with external parties and represent the company's interests
Desirable Skills and Experience:
  • Experience with Class III medical devices
  • Background in new product introduction and ramp
  • Knowledge of design and development process for new products and/or product changes
  • Experience in risk management
  • Ability to advance projects under regulatory oversight
  • Proficiency in Solidworks CAD software and statistical analysis software
  • Working knowledge of regulatory requirements


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