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Senior Product Development Engineer

2 months ago

Carlsbad, United States Gilero Full time
About the Role

We are seeking a highly skilled and experienced Senior Product Development Engineer to join our team at Gilero. As a key member of our product development team, you will be responsible for leading the design, development, and production of medical devices and combination devices.

Key Responsibilities
  • Technical Leadership: Provide technical guidance and oversight to ensure the successful development of products, accessories, and cross-functional initiatives.
  • Product Development: Manage product development deliverables of high complexity through the entire development lifecycle, from concept to manufacturing transfer.
  • Risk Management: Identify, assess, and mitigate technical risks to ensure high-quality outcomes and seamless collaboration with customers, vendors, and internal teams.
  • Team Management: Mentor junior engineers, promote excellence, and foster a culture of innovation and teamwork.
  • Documentation: Create, review, and release documents according to Gilero's Quality Management System (QMS) and the lifecycle of the project.
  • Testing and Validation: Develop test methods and protocols to fulfill state-of-the-art requirements, analyze test data, and interpret results.
  • Project Management: Act as project manager for smaller, technically oriented projects, and support chartering and maintaining project objectives and milestones.
Requirements
  • Education: Bachelor's degree in Engineering or equivalent technical degree.
  • Experience: 5+ years of relevant experience in product development, preferably in the medical device industry.
  • Skills: Strong technical skills, excellent communication skills, and ability to lead teams to achieve difficult goals.
  • Knowledge: Deep understanding of ISO 14971, 13485, and CFR 21, as well as experience with ISO 10993 and GLP.
Personal Attributes
  • Collaboration: Embracing teamwork and transparency, partnering with customers and vendors.
  • Integrity: Doing the right thing at all times, fair and trustworthy, always keeping the patient in mind.
  • Innovation: Open to new ideas, processes, and solutions, leveraging technology to creatively solve problems.
  • Excellence: Delivering exceptional products and services with passion and pride.