- 10 years minimum experience in the medical device or pharmaceutical industry delivering engineering capabilities
- Experience with ISO13485 and FDA regulations and strong understanding of Good Manufacturing Practices (GMP)
- Understand production process validation, are self-driven, desire to solve problems, have the ability to implement effective solutions and possess an understanding of Lean Manufacturing Methodologies
- Degree in Mechanical or Biomedical Engineering from an accredited program or equivalent experience
- Expert in SolidWorks
- Actively pursing or have completed Black Belt
- Learn/train on business units Quality system requirements & Kimball Electronics philosophies and culture
- Build relationships with team members
- Learn ERP system (IQMS) navigation, extraction of documents & change order process
- Learn automated manufacturing lines you are responsible for supporting
- Learn & understand current process bottlenecks
- Offer ways to operations with eliminating process waste
- Design/create tooling, fixtures and equipment
- Create detailed technical documentation such as manufacturing instructions, maintenance instructions, testing procedures & Engineering reports Implement process improvements to eliminate downtime
- Lead validation efforts for commissioning of process improvements
- Participate in Lean manufacturing training and projects (Six Sigma Green/Black Belt)
- Lead & support continuous improvement initiatives by working with CI manager
- Support the manufacturing launch of new/revised products including establishing goals, training team members and evaluating results
- Provide input to customer regarding Design for Manufacturing improvements
- Perform product/process analysis for quality improvements, cost reductions and improved efficiency
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Sr. Manufacturing Engineer - Indianapolis, United States - Kimball Electronics
Description
Kimball Electronics is committed to working with and providing access and reasonable accommodation to applicants with mental and/or physical disabilities. If you think you may require accommodations for any part of the recruitment process, please send a request to . All requests for accommodations are treated discreetly and confidentially, as practical and permitted by law.
No Visa sponsorship is available for this position.
Kimball Medical Solutions is a Medical Device Contract Manufacturer in Indianapolis, IN. This is an onsite position that will report directly to the Manufacturing Engineering Team Lead.
Position Overview
The Sr. Manufacturing Engineer will help with the development, implementation, of new manufacturing processes, lead manufacturing processes, drive improvements while meeting goals of quality, cost and delivery for our customers. You are a consistent leader on continuous improvement initiatives and helping to mentor others in the group.
Quick Summary
As a diversified contract medical device manufacturer this position offers you the opportunity to work on some of the markets most exciting lifesaving products. You will contribute to our company's overall success by developing manufacturing process, designing tooling/equipment, conducting tests, troubleshooting and creating solutions to challenging problems. Working on multiple customer focused projects while breaking down complex projects into multiple tasks using data driven corrective action methods for processes. You will have the opportunity to enhance and offer guidance to others from your years of experience in a highly regulated environment. In our business, it is critical the candidate has a mastery of understanding the importance of quality, regulatory requirements and good team work.
Background Requirements
Considerations for this outstanding opportunity to support the manufacture of life saving devices will be given to candidates that possess:
Key Performance Objectives
Short Term: (0 to 3 months)
As a global company, we value a culture of curiosity, diversity of thought, and innovation from our employees, customers, and partners. Kimball Electronics is committed to a diverse and inclusive work environment where all employees' differences are celebrated and supported, and everyone feels safe to bring their authentic selves to work. Kimball Electronics is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, ancestry, religion, sex, national orientation, sexual orientation, age, marital status, disability, gender identity, gender expression, Veteran status, or any other classification protected by federal, state, or local law. We strive to create a workplace where every voice is heard, and every idea is respected.
