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.
...some of the highest take home pay by paying you for every dispatched mile right up to the day before payroll. Driver Pay : Solo Company - Starting up to $.60 CPM - Increases every 50,000 Miles - No Cap! Team Drivers - Base at $.75 CPM - Increases every 100,000...
...KAG Energy, a division of Kenan Advantage Group, is currently hiring Local Truck Driver in your area! Join KAG today to take advantage... ...to support your overall quality of life~401(k) with company match~ Paid training on product handling and incentives for...
...Work at Home Data Entry Clerk - Part Time We are presently looking for on-line support in our Work at Home Panelist Program. This is... ...computer and have at the very least a typical working degree typing capacity. - You need to be professional and positive and also...
...collections, sliding fee applications, secondary billing, and other duties, as assigned to support... ...of basic patient accounting and medical billing principles Data entry in a high... ...wellness include: Patient Centered Medical Home Accreditation Age Friendly Care Health...
We are hiring Unarmed Security Officers for on-call and flexible positions, with potential to transition to permanent full-time or part... ...hour security certificate, and a valid PERC. Attend our hiring event on January 8th from 10:00 AM to 2:00 PM at 1000 Jorie Blvd, Suite...