Product Development Engineer II

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.

Responsibilities

• Design and develop ENT medical devices and related accessories (e.g., cables, sheaths, suctions).
• Collaborate with external vendors to develop and procure components; 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 create engineering prototypes.
• Develop and execute engineering tests, including benchtop, verification & validation (V&V), and pre-clinical studies; author comprehensive protocols and reports.
• Communicate project status, risks, and opportunities effectively to project teams and 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.
• 3–5 years of related experience in medical device product development.
• Proficiency with CAD software (e.g., SolidWorks).
• Demonstrated ability to work effectively within cross-functional technical teams.
• Strong verbal and written communication skills, with experience in project management, problem-solving, and presentations.
• Proficiency in Microsoft Office applications (Word, Excel, PowerPoint).
• Advanced degree in Engineering, Physical Sciences, or a related field.
• Working knowledge of design controls, risk management (ISO 14971), production/process controls, and relevant standards (e.g., ISO 13485, FDA Quality System Regulation).
• Experience with statistical software (e.g., Minitab), process mapping (Visio), and project management tools (Microsoft Project).
• Strong business acumen and the ability to collaborate across all levels of the organization.
• Travel: Up to 25%.

Physical Requirements

• Computer work, standing, sitting, walking, light lifting, talking, hearing, and hand-eye coordination.

Work Environment

• Onsite Lab and Office.

Pay

Pay Range: $71,300.00 - $97,750.00 USD