Senior Product Development Engineer I

About the role

Joining us is a chance to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, our colleagues are challenging what’s possible and making headway to innovate new treatment pathways to advance patient outcomes and set new standards of care.

Responsibilities

• Design and develop ENT medical devices and related accessories (e.g., cables, sheaths, suctions, balloons).
• Interface with external vendors to develop and procure components; proactively resolve design challenges related to materials, specifications, tolerances, service requirements, manufacturing processes, and cost.
• Create preliminary sketches and detailed design concepts; perform measurements, analyses, and produce engineering prototypes.
• Develop and execute engineering tests (benchtop, verification & validation (V&V), pre-clinical, and usability); author detailed protocols and comprehensive reports.
• Gather Voice of the Customer (VOC) input from physicians and end-users to inform product requirements and improvements.
• Lead technical reviews, including design reviews and technical assessments.
• Recommend, design, and/or purchase equipment needed for development and testing.
• Communicate project status, risks, business-related issues, and opportunities effectively to the next level of management.
• Ensure compliance with all applicable federal, state, and local regulations, as well as company policies related to Health, Safety, and Environmental practices.

Qualifications & Requirements

• Bachelor’s degree in engineering (or equivalent) required.
• At least 4 years of related experience in medical device product development.
• Proficiency with CAD software (e.g., SolidWorks).
• Demonstrated ability to lead technical teams.
• Strong verbal and written communication skills, with solid experience in project management methodology, problem-solving, and presentations.
• Strong business acumen and the ability to collaborate effectively with all levels of management in a cross-functional team environment.
• Proficiency in Microsoft Office applications (Word, Excel, PowerPoint).
• Mechanical Engineering degree preferred.
• Working knowledge of design controls, risk management (ISO 14971), production and process controls, and relevant regulatory standards (ISO 13485, FDA Quality System Regulation).
• Experience with statistical analysis software (e.g., Minitab), process mapping (Visio), and project management tools (Microsoft Project).

Pay

Pay Range: $81,650.00 - $112,700.00 USD