Systems Engineer, Medical Device

Mizuhosi; Union City (CA); Hybrid; USD 82,000 - 150,000; Full time

Benefits offered by this job

Medical, dental, vision

401k with matching

Educational assistance

Job summary

Mizuho OSI in Northern California is seeking a Systems Engineer to join a small, agile team responsible for medical device development from concept through testing.

You will translate customer needs into requirements, integrate software-controlled electromechanical systems, and ensure design history files and plans are maintained. Senior roles may lead projects and mentor others. We offer a comprehensive benefits package and annual bonus.

Qualifications

• Bachelor's degree in engineering or related field and relevant experience.
• Strong analytical skills and ability to apply engineering principles.
• Solid understanding of systems engineering principles and methods.
• Ability to translate customer needs into design requirements and performance.

Responsibilities

• Create innovative solutions addressing user needs and differentiating products.
• Translate customer needs into requirements; document design inputs/outputs.
• Collaborate to determine best technologies for the product.
• Develop and maintain design history files and deliverables.
• Plan milestones, schedules and task lists; manage data and issues.
• Maintain knowledge of medical devices, regulations and quality systems (FDA 21 CFR 820).
• Perform risk management, mitigate and document actions.
• Execute engineering, verification, validation testing with protocols and reports.
• Develop processes and tools for testing and evaluation.
• Support design transfer to manufacturing and serviceability.
• Support sustaining activities including reliability and manufacturability improvements.

Skills

Analytical thinking

Systems engineering

Team collaboration

Problem solving

Education

Bachelor's degree in engineering or related field

Master's degree (preferred)

Tools

MATLAB

LabVIEW

EA (Engineering Applications)

Job description

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Mizuho OSI is the leader in the markets for specialty surgery and patient positioning. The company’s portfolio includes specialty surgical tables for procedure-specific approaches that improve patient outcomes in spine and orthopedic surgeries along with disposable and reusable surgical patient care products.

Job Summary

As Systems Engineer you will be part of a small, agile team; responsible for medical device development projects starting from technology exploration, product definition, to guiding integration with software controlled electromechanical systems; ending with product and release testing.

At more senior levels you may:

• Share and provide technical expertise and guidance to other engineers and designers.
• Lead projects and team as assigned.
• Familiarity with Engineering Applications like MatLab, LabView or EA.

We develop a broad spectrum of products from sterile disposables to complex capital equipment using a customer-centric, collaborative, innovation driven approach. We value ownership, calculated risk-taking, and tolerance for ambiguity as we build future devices and improve existing products.

We are looking for you, if you have:

• Curiosity to explore new approaches and innovative solutions.
• Intellectual discipline to analyze problems and synthesize solutions.
• Grit to drive challenging projects to completion in a fast-pace environment.
• Enjoy working in a diverse, team driven environment.

Responsibilities:

• Create innovative solutions to address user needs in products that differentiate the company in the market.
• Translate customer needs into requirements and engineering specifications. Document design input & output.
• Meld technical contributors into a unified team and collaborate to determine best technologies for the product.
• Develop, manage and maintain design history files and related deliverables.
• Develop, maintain and execute to plans, milestones, schedules and task lists.
• Manage and logically organize data to identify and describe problems and assess the suitability and quality of technical solutions.
• Maintain up-to-date knowledge of medical devices, technologies and regulatory landscape relate to the company’s products.
• Perform complaint, failure and risk management activities, develop mitigation and risk control strategies and generate supporting documentation.
• Perform engineering, integration, verification and validation testing, including protocol development, report generation and regression analysis.
• Develop and document processes, methods and tools for product testing and evaluation.
• Support cross-functional Design Transfer process to ensure product designs manufacturable & serviceable.
• Support product sustaining activities including value engineering, reliability improvements, manufacturability improvements, field issues with technical and impact analysis.
• Manage, prioritize and align work activities with project schedules.
• 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).

Qualifications & Requirements:

• Bachelor's Degree in Engineering or related field 0-8 YOE, Master’s degree 1-3 YOE, PhD 1+ years of experience.
• Strong analytical skills and ability to apply engineering principles using logical or scientific thinking to define problems, collect data, establish facts, and draw valid conclusions.
• Ability to comprehend an extensive variety of technical instructions in mathematical and/or diagrammatic form and translate that into design requirement and/or performance.
• Ability to find creative or innovative solutions for design of products.
• Solid understanding of systems engineering principles and methods, system modeling and transformation applications.
• Ability to make and communicate decisions in a timely fashion; to formulate and execute a course of action.
• Ability to independently manage and prioritize work based on goals and objectives and provide deliverables in alignment with timelines and deadlines.
• Ability to adjust to changing timelines and priorities in a fast paced environment.
• Ability to collaborate cross-functionally and cross-organizationally and respond to the needs of internal customers.
• Strong interpersonal and communication skills and ability to effectively work in a team.
• Excellent written & verbal English communication skills and strong presentation skills.
• Adept use of Office Applications like MS Outlook, Excel, Word, PowerPoint, Visio and Project.

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Salary range $82,000- $150,000 DOE + potential annual bonus + comprehensive benefits package

EOE STATEMENT

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.

Mizuho OSI conducts criminal conviction background checks and drug screening through a third-party screening vendor which includes searches of address history, criminalconvictions,court records,education verification, employment verification, and reference checks. In addition, depending on the nature of the position for which you are applying, a motor vehicle driving report, a credit report, and/or ID checks in other non-U.S. countries are also included.

Criminal conviction background checks will run after an applicant has received and accepted a conditional offer of employment. After a conditional offer is made and before any background check is performed, applicants will receive background check disclosure and consent forms under state and federal laws, such as the Fair Credit Reporting Act and the Investigative Consumer Reporting Agencies Act. Existence of a criminal record is not an automatic bar to employment. An assessment will be made about whether the conviction has a direct and adverse relationship to the job in question.No job offer will be withdrawn, and no adverse action will be taken against any employee, based on the results of a criminal conviction background check, without an individualized assessment of whether the applicant’s conviction history has direct and adverse relationship with the specific duties of the job in question.

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.

BENEFITS

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.

FOR OUR SERVICE MEMBERS AND VETERANS

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 [phone].

FOR PERSONS WITH DISABILITIES

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 [phone].