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Senior Quality Engineer

Precision Neuroscience
Dallas, TX Full Time
POSTED ON 2/28/2025
AVAILABLE BEFORE 5/25/2025

Senior Quality Engineer

Department : Precision

Employment Type : Full Time

Location : Dallas, Texas

Reporting To : Ronald Gonterman

Description

Precision Neuroscience is pioneering a brain implant, known as a brain-computer interface (BCI), to restore communication and independence for people with neurological conditions. Our cutting-edge technology is designed to empower people with paralysis to control digital devices-such as computers and smartphones-with their thoughts alone, opening new possibilities for daily life.

Precision's multidisciplinary team brings together leading experts in diverse fields such as neurosurgery, artificial intelligence, machine learning, microfabrication, electrical engineering, and more. We are committed to turning breakthrough scientific advancements into real-world solutions for people affected by conditions such as spinal cord injury, stroke, and ALS.

As a Precision employee, you will be joining one of the fastest moving and best-capitalized companies in the emerging field of BCI. Since our founding in 2021, Precision has secured over $155 million in funding, developed and validated our technology, and initiated human trials in collaboration with some of the nation's top hospitals.

We are seeking a Senior Quality Engineer to join our Quality Team. In this role you will apply your expertise in supplier development at Precision BioMEMS, a wholly owned subsidiary of Precision Neuroscience. This is an exciting opportunity for you to build your career in a startup while working at an established microfabrication facility.

Precision BioMEMS operates a 22,000 square foot micro-electrical mechanical systems (MEMS) fabrication facility in Addison. The BioMEMS team collectively has decades of experience in MEMS, both for R&D projects and high quality production, and are continually exploring the most cutting-edge processing methods.

Our Quality Team is responsible for establishing, implementing, and maintaining Quality processes and policies for Precision Neuroscience. The Quality Team plays a crucial role in the product development cycle, the software development lifecycle, supplier sourcing and development, risk management, and verification and validation, among other activities.

This position is on-site five days per week at our Addison, Texas facility. We are unable to consider remote workers or people not currently based in the United States, and who do not have working rights.

Key Responsibilities

  • Own supplier quality output and deliverables for Precision Neuroscience's (PN) wholly owned MEMS (Microelectromechanical systems) microfabrication subsidiary, Precision BioMEMS (PBM), as an onsite engineer.
  • Serve as quality / customer representative for design / development projects and various other assigned projects.
  • Ensure adequate design control documentation and records are maintained to support compliance with regulatory requirements.
  • Work closely with PBM personnel on product development, master validation plans, V&V, and design transfer into manufacturing.
  • Collaborate with PN Quality, PN Regulatory, and PBM teams to address potential process / recipe changes to previously cleared process flows / recipes.
  • Collaborate with PN Quality, PN Microfabrication, and PBM teams to evaluate and improve process yield and implement quality guidelines at wafer level test and inspection.
  • Create or provide guidance on protocols and reports for various design aspects for microfabrication and future contract manufacturer / end assembly efforts while ensuring compliance with industry standards.
  • Support quality system processes including CAPAs, internal audits, NCRs, Supplier Quality and Complaint Handling systems.
  • Support external quality audits as necessary.
  • Perform additional responsibilities or other functions as assigned.

Skills, Knowledge and Expertise

Required Qualifications :

  • BS or more in relevant engineering or scientific discipline.
  • 5 years' medical device industry experience.
  • Experience in working at a microfabrication facility or pharmaceutical manufacturing facility, or direct experience in managing microfabrication and / or microelectronic assembly plant vendors in a supplier development role.
  • Experience working with Class II or III medical devices.
  • Experience in manufacturing medical devices in conformance with Quality System Regulation and ISO 13485 requirements or with ISO 9001.
  • Excellent interpersonal written and verbal communication skills.
  • Preferred Qualifications :

  • Experience working at a microfabrication facility, including SEMI, MEMS, or BioMEMS focused facilities.
  • Proficiency with medical device development lifecycles and manufacturing processes and technologies.
  • Ability to focus on and achieve scheduled milestones, including contingency planning.
  • Strong knowledge and understanding of FDA regulations (21 CFR 820), ISO 13485, and ISO / IEC standards related to medical device manufacturing.
  • Strong team-working and communication skills. A drive to get the job done in the face of obstacles and time constraints, and a willingness to jump in wherever needed.
  • Diverse workforces create the best culture, company, and products. We at Precision are committed to an inclusive culture that celebrates the uniqueness and contributions of everyone.

    As an equal opportunity employer, Precision does not discriminate on the basis of sex, race, religion, national origin, disability status, protected veteran status, or any other characteristic protected by law.

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