Senior Quality Engineer (Medical Equipment Investigator)

  • Engineering
  • Santa Clara

Fresh Consulting is a design-led, software development and hardware engineering company, offering end-to-end digital services to help companies innovate.  We bring together amazing UX designers, sophisticated developers, digital strategists, and top-notch engineers to help companies create fresh experiences that connect humans, systems, and machines.  We’ve been growing fast and need someone to help us continue to manage the delivery of high-quality work in a fast-paced environment. 
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Title: Senior Quality Engineer
Duration: 9 months contract with extension leading to contract-to-hire.
Location: Santa Clara, CA
Benefits: Employee benefits at 100% including Medical, PTO, Holiday Pay, 401K Plan and much more!
Hours: Minimum 40 Hours/Week 

Must be onsite. Proof of vaccination is required.

– Work with quality and engineering team for guidance.
– Help perform complaint investigations. 
– You will receive initial training from quality engineers on how to perform certain types of complaint investigations – depending on your ability to learn how to perform those investigations, you will either be instructed on what to investigate on every complaint or be trusted to make that decision on your own.
– Be expected to inspect the returned devices for visual and functional defects. 
– Responsible for developing, applying, revising and maintaining quality standards for processing materials/products into partially or finished products.
– With minimal support, designs and implements methods and/or procedures for inspecting, testing and evaluating the precision and accuracy of products, components, sub-assemblies and/or production equipment.
– Analyzes nonconformance reports and returned products, and recommends corrective action.
– Prepares documentation for inspection/testing procedures, development studies, validation protocols and reports, quality plans, product defect investigations and inspection plans. Must be able to write a technical document with sufficient clarity, detail and correctness to be submitted for regulatory review with confidence. 
– Must be able to review and provide value-added feedback to others writing such documents.  
– Plans and conducts work requiring judgment in the evaluation, selection, adaptation and modification of standard techniques, procedures, and criteria. 
– Provides support to manufacturing and development engineers regarding documentation, process controls, data feedback systems, and best quality practices.
– Performs most assignments with some guidance and with an understanding of the overall expectations. 
– Receives technical guidance on unusual or complex problems and supervisory approval on proposed plans for projects. 
– Plan, schedule, conduct, and coordinate detailed phases of engineering work as part of new or on-going projects.
– Familiarity with FDA guidance documents and ISO and ASTM standards related to quality and medical device industry is an asset.
– With minimal guidance, assesses if components, sub-assemblies, and products meet specification and can initiate, investigate, and resolve non-conformances by working in conjunction with a multi-disciplinary team.
– Responsible for participating in design reviews and pre-validation assessments to support the safe and environmentally sound start-up of new processes, and ensure the process has adequate and appropriate process controls. Responsible for participating and/or taking lead role in developing the risk management plan for new projects transitioning into manufacturing. (Hazard assessment, design trace matrix development, DV&V testing, and FMEA).
– May technically supervise or coordinate the work of others who assist in specific assignments.
– Practices company safety, quality policies and procedures.
– May conduct internal and supplier audits.
– Processing, investigating, and completing customer complaints, which could require direct email responses to customers.
– Composes technical complaint reports timely and accurately based on reported information and device investigation data.
– Knowledge of statistics and minitab, including process capability and data normality assessments, analysis of variance, hypothesis testing, determining appropriate sample sizes, tolerance interval assessments for variable and attribute data, design of experiment (DOE), and variable and attribute sampling plan applications would be a great asset.
– Work on catheters, electronic components. 
– Experience with medical equipment.

– Experience working at a manufacturing company not a CM.
– Experience investigating “why” medical device get returned. 
– Ideally someone with several years of experience as technical contributor. 
– Experience with root cause analysis when a device gets returned if they does not work properly, or if a doctor has issues with them.
– Experience with medical hardware device testing and sustainment.
– Experience working with Quality Technicians that perform decontamination/disinfecting/cleaning etc.
– Experience using microscopes and image capturing systems to take pictures of the defects to include with the complaint investigations.
– Technical engineering (ideally medical devices) background who can learn and take directions from others, and has the potential to think critically and problem solve.
– Be a certified engineer. 
– Effective communication skills with all levels of management and organizations.
– Ability to work in a fast-paced environment while managing multiple priorities.
– Operate as a team and/or independently while demonstrating flexibility to changing requirements.
– Employee may be required to lift objects up to 25lbs.
– Strong understanding of engineering materials, component selection, and design for reliability and manufacturability.

Preferred Skills:
– Engineering experience in the medical device industry is highly preferred.
– Knowledge of disposable peripheral and coronary device design, material selection, and testing preferred.
– Experience in early-stage catheter based cardiovascular devices development is a strong plus.

Education: Bachelor’s degree in Mechanical or Biomedical Engineering with 3-7 years’ experience in engineering or a master’s degree with 2-4 years’ of engineering experience preferred

– Work on engineering and research assignments with F500 companies and startups.   
– The relationships that we have created with our clients are one of a kind.    
– We help solve problems in many technologies focusing on R&D, product development, and manufacturing.    
– We work at the most cutting-edge and latest technologies from AR/VR to Autonomous technologies.    
– Closely working with our clients, we believe that long term investments are extremely important to maintain the culture we together have created.

We’re a handpicked team of Engineers, digital strategist, designers, and developers united together in creating a fresh experience. Whether we are strategizing, designing, developing, or analyzing, our integrated team works as an extension of yours to improve your impact, your usability, and your customer conversion. In the process, we collaborate with you to get to know your business, understand your industry, and incorporate your big ideas into memorable experiences that keep your customers coming back for more.

Fresh Consulting is a participating E-Verify company.

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