Position SummaryThe Product Development Engineer II will play a key role in the design and development of innovative ENT (Ear, Nose, and Throat) medical devices at Acclarent. This position supports cross-functional project teams throughout the product lifecycle, with a focus on product design, design for manufacturability (DFM), test method development, and product verification and validation (V&V) activities. The role requires a hands-on engineer who can translate concepts into reliable, high-quality medical devices while ensuring compliance with regulatory standards and business objectives.
Key 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.
- Develop tools, jigs, and fixtures to support prototyping, manufacturing, and testing.
- 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.
- Perform other duties as assigned.
Qualifications & Requirements
Qualifications:- 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
- Ability to thrive in a fast-paced, stressful environment; strong analytical/problem-solving skills; team collaboration; continuous learning mindset.
Salary Pay Range:
$71,300.00 - $97,750.00 USD Salary
Our salary ranges are determined by role, level, and location. Individual pay is determined by several factors including job-related skills, experience, and relevant education or trainingIn addition to base pay, employees may be eligible for bonus, commission, equity or other variable compensationYour recruiter can share more about the specific salary range for your preferred location during the hiring process.
Additional Description for Pay Transparency:
Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance, and savings plan (401(k)).
Subject to the terms of their respective policies and date of hire, Employees are eligible for the following Total Rewards | Integra LifeSciences
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