Job Description
Nextern is looking for a talented Senior Design Assurance Engineer to join our innovative team. This role involves ensuring that our product designs meet rigorous quality and safety standards throughout the development process. You'll collaborate closely with cross-functional teams to define and implement best practices in design assurance.
DUTIES AND RESPONSIBILITIES:
· Lead the design assurance activities and support product development through design verification and validation.
· Develop and execute risk management and design control documents, including DHF, DMR, and technical files.
· Drive the creation of test protocols and reports, ensuring compliance with regulatory and industry standards.
· Analyze testing data and prepare technical documentation for submissions to regulatory bodies.
· Oversee design reviews and provide constructive feedback to team members.
· Stay updated on industry trends and regulatory changes to continually enhance design assurance practices.
Requirements
QUALIFICATIONS:
· Bachelor’s Degree in Engineering or a related field; Master’s preferred.
· Minimum of 5 years of experience in design assurance within the medical device industry.
· In-depth understanding of design control and risk management principles.
· Proven experience with FDA, ISO, and IEC regulations and standards.
· Proficient in statistical analysis software and methodologies.
· Strong communication skills and ability to work collaboratively in cross-functional teams.
· Demonstrated problem-solving abilities and attention to detail.
Benefits
Nextern offers excellent benefits to fuel you in building a fulfilling life & career:
The pay range for this position is $100,000 - $125,000.
Nextern is an equal opportunity employer. We encourage applications from candidates of all backgrounds and experiences, and we are committed to fostering an inclusive and diverse workplace. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.
Description Summary: The competent Nurse, in the same or similar clinical setting, practices independently and demonstrates an awareness of all relevant aspects of a situation. Provides routine and complex care, with the ability to on long-range goals or plans. Continues...
...looking for a passionate, flexible, committed Cloud Engineer to join our group of highly... ...with cloud platforms (AWS, Azure, or Google Cloud)~ Experience in a DEVOPS role or... ...practices Certifications: AWS Solutions Architect Azure Administrator Google Cloud...
...Job Description Position Summary The Senior Data Scientist will serve as a technical lead in the development of advanced analytical... ..., Measure, Analyze, Improve, Control) methodology to the data science lifecycle. Identify root causes of operational inefficiencies...
...CNA Private Duty Caregiver Job Location: Shelton, Connecticut Private Duty Caregiver Masonicare at Home Per Diem/Hourly Personal and... ...are currently hiring private caregivers and homemakers for live-in OR hourly live-out work throughout the state. Our hourly...
...Description Job description: Financial Advisor- With full training and development program Job description Our financial... ...someone elses life for the better is also life-changing for you personally, professionally, and financially. Have you ever thought of...