Validation Engineer
Validation Engineer
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Salary Not Disclosed
1 Vacancy
Job Description
We are committed to providing reasonable accommodations for individuals with disabilities in our job application process. If you need assistance or an accommodation during the application or recruitment process due to a disability you may contact us at . We will treat all requests for accommodations discreetly.
*Note: There is no Visa sponsorship being offered for this position.
Kimball Electronics does not accept agency resumes. Please do not forward resumes to any recruiting alias or employee. Kimball Electronics is not responsible for any fees related to unsolicited resumes.
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 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:
- 35 years experience in Medical Device manufacturing is key
- Bachelors 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(contd)
- Validation experience process and equipment qualification (IQ OQ PQ) Test Methods & GR&Rs
- 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 minitab
- 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 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
Dont 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 dont necessarily meet every requirement we encourage you to apply. You may be the right candidate for this role or other roles!
Were 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).
Employment Type
Full-Time
