What are the responsibilities and job description for the Senior Quality Engineer position at Precision Neuroscience?
Department: Precision
Location: Dallas, Texas
Precision is building a direct connection between the human brain and computers, to benefit the hundreds of millions of people worldwide suffering from neurological conditions. Established in 2021, we are a leader in the development and commercialization of brain–computer interfaces (BCI).
As a Precision employee, you will be collaborating with experts across a diverse array of fields–including neurosurgery, mechanical engineering, machine learning, and microfabrication–to push the boundaries of what is possible. You will be joining a well-capitalized and fast-moving company. In the three years since Precision's founding, we have built and validated a product and have begun human trials in partnership with some of the country's leading neurosurgery programs. And you will be working toward a deeply meaningful goal: restoring function to people living with devastating neurological conditions, including stroke, spinal cord injury, traumatic brain injury, and neurodegenerative disease such as ALS. Our platform will enable these individuals to regain independence, communicate with loved ones, and return to work.
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.
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.
- 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.
