Manufacturing Test Engineer 2

Date:  Sep 10, 2022
Category:  Manufacturing Engineering

Union City, CA, US

The Manufacturing Test Engineer will evaluate the existing testing solutions and new products and determine the requirements to improve or update existing fixtures, design new solutions for new products as well as existing products. You will be heavily involved in troubleshooting hardware and software issues on the capital equipment and determine or define the product test strategy. You will be designing and documenting new manufacturing equipment with standardization and reliability as a priority and creating test plans for validating the equipment. The ideal candidate is a self-driven individual working in a cross functional team environment. You will enforce manufacturability, testability and ensure cost-effective designs are implemented for testing and automation systems, software, and equipment. This position will have responsibilities for NPI test development and sustaining support of production released test and automation systems. You must be responsive, flexible, and able to succeed within an open collaborative peer environment. We are looking for someone with a productive mindset who can apply their expertise to solve problems in creative, insightful ways.


We are looking for you if you can do the following:

  • Evaluate printed circuit board assemblies (PCBA or PCA) and electro-mechanical systems and determine the best method to test the component and take the evaluation from concept, to test, and implementation.
  • Work collaboratively in cross functional teams which include MPI and R&D to achieve organizational goals
  • Can use design tools like SolidWorks and Altium to develop the fixtures or solutions needed.
  • Report out on project and work status


Here is what you will do day-to-day:

  • Maintain a continuing liaison relationship with R&D engineering, production, and quality functions to ensure readiness to meet commitments of new business and to ensure that production rates and product designs provide effective utilization of available manufacturing resources.
  • Take ownership of new products during pilot production phase through successful and sustained project launch. This includes but is not limited to driving new product introduction schedules, escalating, and resolving manufacturability issues.
  • Design, qualify, document, and introduce test fixtures and equipment.
  • Maintain current knowledge of competitive technologies including medical, technical, manufacturing and material developments as related to company products.
  • Conduct tests to ensure process capabilities utilizing new or existing test protocols
  • Lead or participate in assigned initiatives focused on material cost reduction, capacity enhancement, outsourcing of assemblies, etc.
  • Provide sustaining engineering support to production. Provide training and support to production staff such as Assemblers, Quality Control Inspectors, Leads, and Supervisors.
  • Perform failure analysis and implement corrective action to improve production and quality.
  • Participate in material review board activities to analyze and disposition non-conforming materials.
  • Domestic travel, as needed, to support supplier audits and other business needs, as necessary.
  • Assist in the creation of an ongoing effort to improve the Company and the Manufacturing Department through personal action and by contributing ideas to support both the Department and Company’s ongoing improvement efforts.
  • Understand, support, and follow the Corporate Vision, Mission & Values Statements.
  • Support company goals and objectives.
  • Understand, follow, and support Mizuho OSI’s internal Quality System policies, procedures and work instructions including but not limited to applicable external regulations (21 Code of Federal Regulations Part 820 Quality System Regulations and applicable International Standards).



What you will need to be successful in this role:

  • Bachelor's Degree in Electrical or Electronics Engineering or an equivalent engineering with at least four or more years of experience in the medical device industry or an equivalent similar industry.
  • Thorough knowledge of manufacturing processes and materials.
  • Strong technical skills in prototyping and troubleshooting from engineering documentation
  • Demonstrated Electromechanical and/or Process Engineering capability
  • Familiar with using schematics for both trouble shooting and signal processing. Technical expertise of programs such as Altium or OrCAD is desired.
  • Strong technical skills in prototyping and troubleshooting from engineering documentation
  • Successful working knowledge and experience writing protocols, running tests, and documenting results.
  • Familiar with a 3D solid modeling package, preferably SolidWorks or equivalent.
  • Know how to use an ERP system such as SAP and Business Client or the equivalent.
  • Excellent internal and external customer focus with a high sense of urgency. Ability to interface effectively across the organization as well as outside the company.
  • Ability to function calmly in a fast-paced environment managing multiple priorities simultaneously.
  • Experience in a medical device manufacturing environment preferred.
  • Excellent computer skills with Windows OS-based programs and can navigate through web-based programs and services. Ability to use Microsoft products efficiently and effectively such as Outlook, Word, Excel, PowerPoint, SharePoint, and OneNote.
  • English is the primary language and can clearly express oneself verbally in the English language. The ability to converse in a second language is welcome.
  • Ability to express oneself clearly and effectively through written means, to properly use such technical factors as grammar, punctuation, vocabulary, and correct spelling.
  • Ability to work with a professional and positive attitude to proactively support and implement the continuous improvement efforts of manufacturing teams to meet the department goals and objectives.
  • Ability to travel to vendor sites as required by management (less than 10% travel).


What you need to be prepared for:


  • Job duties are performed in an office environment, assembly floor, and at suppliers. Job duties are performed in an office environment utilizing standard office equipment such as a computer, photocopier, and telephone. The noise level in the work environment is usually low to moderate.
  • Within the Assembly/Production floor the employee may be exposed to sharp objects, small tools, hot objects, adhesives, UV light, various testing equipment, isopropyl alcohol, soldering equipment, hi-pot testers, and other electrical test equipment, etc. The noise level in the work environment is usually moderate to high.
  • Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.


NOTE: This job description in no way states or implies that these are the only duties or functions to be performed by the incumbent. Employees will be required to follow any other job-related instructions and to perform any other job-related duties/functions requested by their supervisor.


Top Reasons To Join The Mizuho OSI Team

• Privately held company with a tradition of market leadership and best-in-class innovation
• Fast-paced entrepreneurial culture focused on dramatically improving patient outcomes through personal empowerment
• Emphasis on continuous improvement and celebration of our values of R.E.S.P.E.C.T. and the Mizuho OSI Way.
• Create innovative solutions designed and manufactured at our HQ in Northern California

The Mizuho OSI Way

In 1978, we set out to change the way patients undergo surgery. As a Mizuho OSI customer, you can expect our commitment to the following…
• We commit to your satisfaction. If you are dissatisfied, we will strive to make it right.
• We do things the right way. We commit to hire people with competence, generosity and a caring attitude.
• We motivate our employees to use their individual strengths to provide creative solutions, changes, and innovations.
• We anticipate your needs through customer experiences, thus nurturing our relationships.

Collectively, this creates an environment that enables and inspires healthcare professionals to improve the lives of patients.
Dare to go further. Care to do more.


Mizuho OSI is an Equal Opportunity Employer and makes business decisions based on job related criteria only. Company policy prohibits unlawful discrimination based on race, color, religious creed, gender, religion, marital status, registered domestic partner status, age, national origin or ancestry, physical or mental disability, medical condition including genetic characteristics, sexual orientation, sexual identity, or any other consideration made unlawful by federal, state or local laws.


At Mizuho OSI, we believe better solutions and decisions are born of diversity and are proudly an EEO/AA employer. We offer a comprehensive benefits package that includes: medical, dental, vision, life insurance, 401k with matching, educational assistance and more.


Mizuho OSI values the service Veterans and their family members have given to our country and we support the hiring of returning Service Members and military spouses. If you are a Veteran or wounded warrior and would like assistance with the employment process at Mizuho OSI, please contact HR at (510) 429-1500.


If you are a person with a disability or a disabled Veteran and are applying for a job with Mizuho OSI, we would like to ensure your application process goes as smoothly as possible. If you need additional assistance, information or answers to your questions, feel free to contact HR at (510) 429-1500.

Nearest Major Market: San Francisco
Nearest Secondary Market: Oakland