The Design Quality Engineer is responsible for ensuring quality and compliance throughout the design & development process for medical devices with an electrical manufacturing background, with a focus on risk management, design verification, and regulatory requirements. The role involves collaboration with cross-functional teams to maintain product integrity & support continuous improvement initiatives.Client DetailsMy client is a pioneering medical device company dedicated to transforming the treatment of cardiac arrhythmias. Renowned for its innovative HeartLight - Endoscopic Ablation System, the company combines cutting-edge technology with a patient-first philosophy to deliver exceptional outcomes in the treatment of atrial fibrillation. Its team of talented professionals works collaboratively to drive advancements in cardiac care, earning recognition for both technical excellence and clinical efficacy.The company fosters a culture of innovation, integrity, and teamwork, empowering employees to contribute meaningfully to life-saving solutions. My client is celebrated for its commitment to quality, safety, and compliance, ensuring its products meet the highest standards in the industry. Its leadership team is visionary and supportive, creating a workplace that values growth and professional development. The company also invests in research and development, staying at the forefront of electrophysiology and ablation therapy advancements. Overall, my client exemplifies excellence in medical technology, making a significant difference in the lives of patients and their families worldwide.DescriptionDESIGN QUALITY ENGINEER:
- Support Product Development: Ensure quality and regulatory compliance throughout the design and development lifecycle of medical devices.
- Risk Management: Conduct and maintain risk assessments such as FMEAs (Failure Modes and Effects Analysis) to identify and mitigate potential product risks.
- Design Verification and Validation: Oversee design verification and validation activities, ensuring product requirements are met effectively.
- Regulatory Compliance: Ensure adherence to applicable regulatory standards such as ISO 13485, FDA 21 CFR Part 820, and IEC 60601.
- Document Control: Create, review, and maintain design history files (DHF) and other technical documentation to ensure traceability.
- Change Management: Evaluate and approve design changes for potential impacts on quality, reliability, and compliance.
- Process Improvement: Drive continuous improvement initiatives by identifying opportunities to enhance design and manufacturing processes.
- Cross-Functional Collaboration: Partner with R&D, manufacturing, and regulatory teams to align on project goals and quality objectives.
- Supplier Quality Management: Work with suppliers to ensure components and materials meet quality and performance standards.
- Audit Support: Participate in internal and external audits, providing evidence of compliance with design control requirements.ProfileDESIGN QUALITY ENGINEER:
- B.S. DEGREE
- ELECTRICAL MANUFACTURING BACKGROUND
- Strong Technical Background: Holds a degree in engineering or a related technical field, with a solid understanding of medical device design and manufacturing processes.
- Regulatory Knowledge: Experienced in applying industry standards like ISO 13485, FDA 21 CFR Part 820, and IEC 60601 to ensure compliance.
- Quality Systems Expertise: Proficient in design controls, risk management (e.g., FMEA), and document control processes for medical devices.
- Problem-Solving Skills: Demonstrates a methodical approach to troubleshooting and resolving complex technical and quality issues.
- Communication Abilities: Strong written and verbal communication skills for effective collaboration and clear documentation.
- Collaboration-Oriented: Skilled at working cross-functionally with R&D, manufacturing, and regulatory teams to achieve common goals.
- Attention to Detail: Highly organized and detail-oriented, ensuring accuracy in quality documentation and assessments.
- Experience in Verification/Validation: Familiarity with design verification and validation protocols, including test method development and execution.
- Continuous Improvement Mindset: Passionate about identifying and implementing process enhancements to improve quality and efficiency.
- Adaptability and Initiative: Thrives in a fast-paced, dynamic environment, showing flexibility and a proactive attitude toward challenges.Job Offer
- Competitive compensation
- State of the art technology & facility
- 401(k) Retirement Plan: With employer matching contributions to help employees save for retirement.
- Health Insurance: Including medical, dental, and vision coverage to support overall well-being.
- Paid Time Off (PTO): Generous vacation, sick leave, and holiday pay.
- Life and Disability Insurance: Coverage for both short-term and long-term disabilities.
- Professional Development Opportunities: Training and advancement programs to help employees grow within the company.
- Wellness Programs: Encouraging a healthy lifestyle with various wellness initiatives.MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.