Principal Product Development Engineer

• Lead and manage the product development process, from concept through to commercialization, ensuring that projects are delivered on time and within budget
• Define product specifications and requirements in collaboration with cross-functional teams
• Conduct thorough risk assessments and implement strategies to mitigate potential issues
• Collaborate with regulatory affairs and quality assurance team to ensure compliance with all relevant regulations and standards
• Collaborate with R&D on the creation of prototypes and conduct experiments to determine validity of designs
• Perform and/or manage design verification, equipment qualification and product and process validation
• Use CAD software (Solidworks) for part and assembly design and detail drawings
• Work closely with manufacturing team to facilitate the transition from development to production
• Manage the budget for product development, optimizing costs while maintaining high product quality and compliance
• Engage in completing necessary documentations as well as maintaining comprehensive documentation of all product development activities, including design specifications, test results, and regulatory submissions
• Demonstrate a keen ability to recognize and address problems and challenges as they arise during the product development process and collaborate with the appropriate team to identify and implement effective solutions
• Utilize written and verbal instructions to ensure the proper assembly and packaging of products
• Other duties as assigned

• Bachelor’s Degree in mechanical or biomedical engineering or equivalent experience
• 7 – 10 years industry experience with a medical device company
• Demonstration of excellent communication (written and oral) skills
• Demonstration of excellent organizational skills with the ability to adapt to a rapidly changing environments
• Prior experience with non-invasive medical devices (catheters)
• Ability to present/teach detailed technical information, to all levels of company personnel and customers
• Extended periods of sitting
• Extended usage of a microscope
• Moderate lifting

Prior experience working on minimally invasive medical devices and/or associated processing technologies

• Medical Insurance, Dental Insurance, and Vision Insurance, 100% paid for employee
• 401K Plan