Validation Engineer

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We provide 3 weeks of PTO starting your 1st year in addition to 10 paid holidays. Annual profit sharing bonus based on company performance. Major health, dental, vision, and complementary insurances starting day 1. We offer a 50% match on your first 6% of 401k contribution with opportunity for an employer contribution annually and you are vested 100% immediately.

Quick Summary

As Validation Engineer for this contract medical device manufacturer, you are responsible for the development/authoring Validation Plans (VP) and protocols for all phases of the validation lifecycle Execution of test protocols and analysis of data using statistical techniques, tools and software. In addition, the Validation Engineer will be responsible for scheduling and hosting Validation Review meetings, reviewing and approving any validation documentation and the allocation of resources to support new or existing validation projects.

You should be able to manage projects that may compete for your time while keeping accurate records of work. In our business, it is critical you can demonstrate a solid understanding of the importance of quality and documentation with timely consistent and accurate records of work and possibly training other employees.

Basic Background Requirements

This position will require:

• 3-5 years' experience in Medical Device manufacturing is key
• Bachelor's degree in Engineering or Engineering Technology (Mechanical, Electrical, Biomedical)
• Knowledgeable on ISO13485, regulatory requirements, and FDA 21 CFR 820/GMP Medical Device Regulations
• Experience with different manufacturing processes, such as automated assembly lines, manual assembly processes, molding processes and packaging processes.

Basic Background Requirements(cont'd)

• Validation experience, process and equipment qualification (IQ, OQ, PQ), Test Methods & GR&R's
• Process development/characterization experience
• Ability to analyze data through the use of statistical principals (e.g. process capability, normality test, GR&R, etc.) and statistical software (e.g. Minitab)
• Ability to compose professional and engineering documentation (e.g. protocols, engineering studies, reports, etc.)
• Ability to manage time and projects effectively while setting and meeting aggressive schedules
• Quality oriented individual with a focus on making data driven decisions
• Proficient with the use of Microsoft tools (Word, Excel, Project, Power Point, Visio)
• Ability to understand business, legal and regulatory requirements

Key Performance Objectives

Short Term: (0 to 3 months)

• Establish and participate in Validation Review meetings
• Establish or review validation documentation to ensure it is in alignment with QS & regulatory requirements
• Assists with or creates protocol & report generation for process & equipment validations
• Work directly with medical device customers on a validation process
• Analyze data statistically using mini-tab
• Assist in validation efforts for commissioning of production systems
• Maintain system documentation in support of FDA regulatory requirements

Midterm: (3 to 6 months)

• Train other engineers on validation practices and techniques
• Collect & share validation program data
• Work with project/program managers in the execution of project plans
• Lead the VRB meetings
• Participate in Lean manufacturing training and projects

Long term: (6 to 12 months)

• Champion the validation program by leading validation continuous improvement activities
• Review and approve all validation protocols and reports
• Provide training and guidance to other validation team members

Don't meet every single requirement? Studies have shown underrepresented groups are less likely to apply to jobs unless they meet every single qualification. At Kimball Electronics we are dedicated to building a diverse and inclusive work environment. If you think you might be a good fit for a role but don't necessarily meet every requirement, we encourage you to apply. You may be the right candidate for this role or other roles!

We're proud to be an equal opportunity employer and consider qualified applicants without regard to race, color, religion, sex, national origin, ancestry, age, genetic information, sexual orientation, gender identity, marital or family status, veteran status, medical condition or disability or any other characteristic protected by applicable federal, state, or local law.

We will consider for employment qualified candidates with arrest and conviction records, consistent with applicable law (including, for example, the San Francisco Fair Chance Ordinance for roles based in San Francisco).