Quality Engineer - (Class Iii Medical Device)

The Company: Our client is a global, commercial-stage class III active implantable Medical Device company whose nerve stimulation solution is about to disrupt a $10B market! About 110 employees +.

Opportunity & Impact: This market/patients have been underserved for a long time with outdated conventional treatment and lack of innovation (legacy incumbent's technology implants a battery/necessitates multiple surgeries for maintenance). In contrast, our client's breakthrough solution has a multitude of benefits designed with the patient in mind. Notably, it requires only a single, minimally invasive incision and no implantable battery. It holds a CE Mark and is commercially available in Europe.

The company is now poised to achieve a major milestone in its history. Over the next few months, they will report results, file for FDA approval and begin preparations to enter the US market for a end of year launch.

The Role: We are looking for a dynamic Quality Engineerto take on the role of leading all Quality Engineering activities to support the new product life cycle, from concept through commercialization. You will spearhead the collaboration with the RD&E - Manufacturing organizations.

Specifically:

• Responsible for product development programs and device design for class III Medical Device including design control, risk management, design verification, compliance, product reliability.
• Support R&D in the development and transition of new product to Manufacturing/Contract Manufacturing.
• Serve as the Design Assurance lead on new product development teams, ensuring the generation of appropriate documentation (DHF, DMR, Technical Documentation, etc.) to support Class III/PMA submissions.

You will play a pivotal role in securing FDA approval and enabling commercial launch!

Preferred Locations: This position is entirely remote, with occasional travel to NYC & EU. Preferred locations include Massachusetts, Minnesota, or any state in the CST/EST time zones.

Qualifications:

• Bachelor’s degree in relevant engineering field (e.g. Mechanical Engineering, Electrical Engineering, Systems Engineering); Master’s degree a plus. Field of study within Biomedical Engineering is nice to have.
• 5+ years of Quality Engineering/NPI/NPD experience in Medical Devices, encompassing Class III/PMA.
• Combination of OEM and Contract Development and Manufacturing Organization experience for class III/Active implantable Medical Devices great to have.
• Experience serving as the Quality Team Lead for Design Assurance in New Product Development projects involving Class III, and AIMD Medical Devices.
• Experience supporting regulatory submissions to FDA for Medical Devices (Class III preferred).
• Excellent communication and interpersonal skills.
• Results-oriented with a focus on achieving regulatory milestones.

Immigration sponsorship is not available for this position. You must be legally authorized to work in the United States

AIMD, class III, class 3, PMA, Design Quality Engineering, Design Assurance Engineering, Design Controls, NPI, NPD, R&D Quality, Design Quality

Job Type: Full-time

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Life insurance
• Paid time off
• Vision insurance

Schedule:

• 8 hour shift
• Monday to Friday

Application Question(s):

• Will you now, or in the future, require sponsorship for employment visa status?

Education:

• Bachelor's (Required)

Experience:

• Medical DeviceClass III/PMA: 2 years (Preferred)

Work Location: Remote