Job Description
We are seeking a seasoned Principal Design Assurance Engineer to spearhead our growth. This hybrid role will bridge manufacturing, facilities, and supply chain functions as we transition from development to commercial launch.
This opportunity suits someone who thrives in fast-paced environments, excels in cross-disciplinary collaboration, and takes pride in delivering impactful projects for patients.
* Lead and support Design Verification and Validation testing
* Contribute to corrective and preventive action initiatives
* Manage design control activities, including design reviews and process improvements
* Prepare and maintain technical documentation for regulatory submissions
* Develop and refine test methods, protocols, and associated work instructions
* Support Human Factors and Usability studies
* Influence product and process design decisions aligned with business goals
* Provide coaching, mentoring, and guidance to colleagues
* Ensure smooth transfer of activities from design to manufacturing
Required Skills and Qualifications
We're looking for an innovative thinker with a passion for creative problem-solving and a collaborative team player with excellent communication skills.
* Degree in engineering, science, or a technical discipline (ASQ CQE also accepted)
* 6+ years' relevant engineering experience in Design Assurance
* Experience within ISO QMS or a comparable quality system
* Strong background in design controls, design reviews, and design change processes
* Expertise in FMEA (design and/or process)
* Proficient in root cause analysis and structured problem-solving
* Competent with statistical tools and Microsoft Office (Excel, Word)
Benefits
This opportunity offers the chance to work on challenging projects and develop your skills in a dynamic environment.
* Innovative thinking and creativity encouraged
* Cross-functional collaboration opportunities
* Ongoing professional development and training