Design Assurance Engineer
6 days ago
Job Title:
Senior Design Assurance Engineer
Employment Type:
Contract to Potential Perm-
Pay rate up to $58/hr
Position Summary
The Senior Design Assurance Engineer plays a critical role in supporting medical device product development from concept through commercialization and sustainment. Operating within the Design Quality Assurance (DQA) team, this individual will contribute to high-impact initiatives affecting Active Implantable and Accessory product performance. The role involves close collaboration with cross-functional teams including R&D, Regulatory, Marketing, Medical Safety, Manufacturing, Post-Market Surveillance, and other Quality functions to ensure product excellence and regulatory compliance.
Key Responsibilities
- Apply design engineering principles and tools such as DFMEA, Design Verification & Validation, Benchmarking, Test Method Validation, and Design Transfer.
- Lead or support systematic problem-solving efforts using methodologies like DMAIC, Root Cause Analysis, 5 Whys, Cause & Effect Diagrams, and Is-Is Not analysis.
- Review and approve quality documentation including product specifications, test protocols, and verification reports.
- Collaborate across multiple sites and functions to resolve complex technical issues and guide strategic quality approaches.
- Champion continuous improvement initiatives within local and divisional Design Assurance teams.
- Promote a diverse and inclusive work environment that encourages full participation and contribution.
- Ensure compliance with internal policies, procedures, and quality standards.
- Maintain a strong commitment to patient safety and product quality by adhering to the Quality Policy and documented processes.
Minimum Qualifications
- Bachelor's degree in Engineering or a related technical discipline.
- Minimum of 5 years of relevant experience in the medical device industry.
- Strong knowledge of Quality System Regulations, Medical Device Regulation, ISO 14971, and ISO 13485 with emphasis on design controls and optimization.
- Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook).
- Proven ability to collaborate and influence across cross-functional teams.
- Demonstrated expertise in technical problem-solving and data analysis.
Preferred Qualifications
- Experience in design engineering or process development, including test method and process validation.
- Skilled in writing specifications, test protocols, and technical reports.
- Familiarity with quality tools such as DFMEA, DOE, brainstorming techniques, and root cause analysis.
- Experience in post-market quality activities including returned product analysis and CAPA.
- Background in Class III medical devices, including Electrical Medical Equipment (EME) or Active Implantable Medical Devices (AIMD).
- Strong adaptability and ability to manage multiple tasks effectively.
- Excellent communication skills with the ability to present complex technical information to diverse audiences, including senior leadership.
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