As a Quality Engineer II, you will support the manufacturing, supplier management, and inspections on a daily basis by developing, establishing, and maintaining quality engineering methodologies, systems, and practices with the objective of compliance, safety, and high customer satisfaction. This position will interact externally with contract manufacturers and other component suppliers, and internally with key functions including Manufacturing, Supply Chain, R&D, and Project Management. This is an onsite (4d/wk.) position.
Vicarious Surgical is a next generation robotics company developing a disruptive technology with the goal of increasing the efficiency of surgical procedure, improving patient outcomes and reducing healthcare costs.
Key Responsibilities
- Must be able to interface well with management, Supply Chain, Advanced Manufacturing Engineering, R&D Engineering, and Project Management.
- Support Operations with equipment qualifications (IQ/OQ/PQ), risk analysis (PFMEA), process validations and process improvements. Includes the use of various statistical techniques and quality tools.
- Lead and support test method validations plans/protocols and reports.
- Prepare nonconforming reports as required and assist in the disposition decisions and approval.
- Assist in the development of the inspection department. Establish Quality Inspection Plans for the release of components, assemblies, and finished devices. Conduct quality inspections as needed.
- Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues (e.g., 5 why’s analysis, Is-Is Not analysis, and Six Sigma problem solving methodologies).
- Support quality management programs such as supplier selection and certification. Perform supplier evaluations as needed to assure supplier capabilities including the assessment of the adequacy of inspection methods, manufacturing practices, and control and quality procedures to deliver conforming products in a timely manner.
- Lead supplier audits and work with suppliers to resolve audit findings and/or nonconformances.
- Experienced with statistical techniques, including design of experiments (DOE); able to analyze results.
- Experience with product and packaging labeling.
- Perform internal audits as needed.
- Ability to deliver, meet deadlines and be results oriented.
About You
- 3+ years as an Engineer in a related field or a combination of equivalent education and relevant experience.
- Minimum of a BS in Mechanical Engineering, Electrical Engineering, Biomedical Engineering, Process Engineering, or equivalent degree.
- Highly motivated and self-directed with a strong sense of urgency, with an ability to pull in resources from other departments as required.
- Excellent Communications Skills (oral, written, presentation) at different organizational levels.
- Regulated industry preferred.
- Experience with root cause analysis tools and methods.
- Working knowledge of defect avoidance methodologies such as poke yoke, DFMEA/PFMEA, DOE.
- Travel 10-15%
Together, we share a love for learning and we are passionate teachers. As a company, we set ambitious goals and individually, we share in that ambition. At the office, we enjoy each other’s company during monthly social, catered lunches and company celebrations.
Top Skills
What We Do
Founded in 2014, Vicarious Surgical is a next generation robotics company developing a disruptive technology with the goals of increasing the efficiency of surgical procedures, improving patient outcomes, and reducing healthcare costs. The Company’s novel surgical approach uses proprietary human-like surgical robots to transport surgeons inside the patient to perform minimally invasive surgery. The Company is led by an experienced team of technologists, medical device professionals and physicians, and is backed by technology luminaries including Bill Gates, Vinod Khosla’s Khosla Ventures, Innovation Endeavors, Jerry Yang’s AME Cloud Ventures, Sun Hung Kai & Co. Ltd and Philip Liang’s E15 VC. The Company is headquartered in Waltham, Massachusetts.
Why Work With Us
We are building a team of mission-driven & kind individuals with diverse experiences to execute on our vision as we develop and launch next generation life changing medical technologies. We share a love for learning & we are passionate teachers. As a company, we set ambitious goals & individually, we share in that ambition.
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