Medical Devices H-1B Sponsorship Jobs in Indiana
Indiana's medical devices industry is a growing hub for H-1B sponsorship, anchored by companies like Zimmer Biomet in Warsaw, Cook Medical in Bloomington, and Roper Technologies in Indianpolis. The state's concentration of orthopedic, surgical, and diagnostic device manufacturers creates consistent demand for engineers, regulatory affairs specialists, and quality assurance professionals seeking H-1B visa sponsorship.
Find Medical Devices JobsOverview
Showing 5 of 162+ Medical Devices H-1B Sponsorship Jobs in Indiana
See all 162+ Medical Devices H-1B Sponsorship Jobs in Indiana
Sign up for free to unlock all listings, filter by visa type, and get alerts for new Medical Devices H-1B Sponsorship Jobs in Indiana.
Get Access To All JobsPosition Summary
Provide quality support and assurance for ICU Medical product development. The Quality Engineer will be responsible for development procedures and deliverables, ensuring their compliance with ICU Medical quality system requirements and applicable regulations and standards (such as ISO 13485, ISO 14971, 21 CFR Part 820, and other applicable regulations and standards). The Quality Engineer will provide quality assurance support for product realization/manufacturing teams for the system (includes aspects of electro-mechanical, software and consumable components) product lines. This individual will be the Quality Core Team Member for ensuring products are developed/manufactured utilizing appropriate processes to design the highest level of quality into products as they are developed.
Essential Duties & Responsibilities
- Ensure the safety of products developed by managing the product life cycle activities to meet the quality system requirements.
- Ensure compliance, alignment and consistency with ICU Medical’s quality system and development practices.
- Effectively utilize quality tools and processes such as product and process controls, risk analysis/management tools, validation, design verification, investigations, CAPA data, etc. to assure product quality.
- Prepare, support and ensure the readiness for any potential internal and/or external audits and inspections.
- Perform periodic audits of projects against SOP’s and process.
- Participate in design reviews, test readiness reviews, cross functional teams, risk assessments, code review, and unit test inspections.
- Review, approve and participate in qualification of acquired software and software tools.
- Perform and support product risk analysis and management.
- Utilize a wide variety of data sources including product review, global complaints, manufacturing quality data, etc.
- Monitor product data to identify statistically significant trends and risks.
- Support on-market issue investigations, risk assessments and associated CAPA activities.
- Review and approve resolution of on-market product issues.
- Support regulatory submissions and responses to regulatory inquiries.
- Work special projects as assigned.
Knowledge & Skills
- Expert quality compliance, audit, and investigation skills.
- In depth deep and broad knowledge of Quality Management Systems and experience linking risk management to all elements of the Quality System (Design Controls, CAPA, Complaints, Document Control, etc.).
- Strong knowledge of medical device standards, including but not limited to:
- ISO 13485
- ISO 14971
- IEC 60601
- IEC 62304
- In depth experience with and knowledge of FDA, MDR, and other key medical device regulations.
- Well-developed ability to take a systems approach and to understand the interaction between components (i.e. hardware, software, consumables).
- Proven ability to work closely with engineering teams and members of a cross functional team.
- New product development experience is strongly preferred.
Minimum Qualifications, Education & Experience
- Must be at least 18 years of age.
- Bachelor’s degree in engineering (Electrical, Mechanical, Biomedical, Software) or related field from an accredited college or university is required.
- Minimum of 7+ years of experience in quality engineering, product design or product engineering in the medical device industry.
- ASQ CQE or CSQE required or the ability to obtain within one year.
Work Environment
- This is largely a sedentary role.
- This job operates in a professional office environment and routinely uses standard office equipment.
- Typically requires travel 5% to 10% of the time.
Position Summary
Provide quality support and assurance for ICU Medical product development. The Quality Engineer will be responsible for development procedures and deliverables, ensuring their compliance with ICU Medical quality system requirements and applicable regulations and standards (such as ISO 13485, ISO 14971, 21 CFR Part 820, and other applicable regulations and standards). The Quality Engineer will provide quality assurance support for product realization/manufacturing teams for the system (includes aspects of electro-mechanical, software and consumable components) product lines. This individual will be the Quality Core Team Member for ensuring products are developed/manufactured utilizing appropriate processes to design the highest level of quality into products as they are developed.
Essential Duties & Responsibilities
- Ensure the safety of products developed by managing the product life cycle activities to meet the quality system requirements.
- Ensure compliance, alignment and consistency with ICU Medical’s quality system and development practices.
- Effectively utilize quality tools and processes such as product and process controls, risk analysis/management tools, validation, design verification, investigations, CAPA data, etc. to assure product quality.
- Prepare, support and ensure the readiness for any potential internal and/or external audits and inspections.
- Perform periodic audits of projects against SOP’s and process.
- Participate in design reviews, test readiness reviews, cross functional teams, risk assessments, code review, and unit test inspections.
- Review, approve and participate in qualification of acquired software and software tools.
- Perform and support product risk analysis and management.
- Utilize a wide variety of data sources including product review, global complaints, manufacturing quality data, etc.
- Monitor product data to identify statistically significant trends and risks.
- Support on-market issue investigations, risk assessments and associated CAPA activities.
- Review and approve resolution of on-market product issues.
- Support regulatory submissions and responses to regulatory inquiries.
- Work special projects as assigned.
Knowledge & Skills
- Expert quality compliance, audit, and investigation skills.
- In depth deep and broad knowledge of Quality Management Systems and experience linking risk management to all elements of the Quality System (Design Controls, CAPA, Complaints, Document Control, etc.).
- Strong knowledge of medical device standards, including but not limited to:
- ISO 13485
- ISO 14971
- IEC 60601
- IEC 62304
- In depth experience with and knowledge of FDA, MDR, and other key medical device regulations.
- Well-developed ability to take a systems approach and to understand the interaction between components (i.e. hardware, software, consumables).
- Proven ability to work closely with engineering teams and members of a cross functional team.
- New product development experience is strongly preferred.
Minimum Qualifications, Education & Experience
- Must be at least 18 years of age.
- Bachelor’s degree in engineering (Electrical, Mechanical, Biomedical, Software) or related field from an accredited college or university is required.
- Minimum of 7+ years of experience in quality engineering, product design or product engineering in the medical device industry.
- ASQ CQE or CSQE required or the ability to obtain within one year.
Work Environment
- This is largely a sedentary role.
- This job operates in a professional office environment and routinely uses standard office equipment.
- Typically requires travel 5% to 10% of the time.
H-1B Medical Devices Job Roles in Indiana
See all 162+ Medical Devices H-1B Jobs in Indiana
Sign up for free to filter by visa type, set job alerts, and find employers with verified sponsorship history.
Search Medical Devices Jobs in IndianaMedical Devices H-1B Sponsorship Jobs in Indiana: Frequently Asked Questions
Which medical devices companies in Indiana sponsor H-1B visas?
Indiana has several established medical device employers with H-1B visa sponsorship histories. Zimmer Biomet, headquartered in Warsaw, is one of the largest orthopedic device companies in the world and a consistent H-1B filer. Cook Medical in Bloomington, Biomet (now part of Zimmer Biomet), and DePuy Synthes operations in the state also appear in DOL Labor Condition Application disclosure data as H-1B sponsors. Sponsorship decisions are made case by case and are not guaranteed.
Which cities in Indiana have the most medical devices H-1B sponsorship jobs?
Warsaw is the standout city, known as the orthopedic capital of the world, and hosts the densest concentration of medical device employers in Indiana. Bloomington, Indianapolis, and Fort Wayne also have notable medical device operations. Indianapolis benefits from a broader life sciences presence including regulatory, clinical, and R&D functions that frequently support H-1B filings across multiple device companies.
What types of medical devices roles typically qualify for H-1B sponsorship in Indiana?
Roles that typically qualify are those requiring at least a bachelor's degree in a specific technical or scientific field. In Indiana's medical device sector, this commonly includes mechanical and biomedical engineers, quality engineers, regulatory affairs specialists, software engineers working on device software, and manufacturing process engineers. Positions where any general degree suffices, regardless of field, are less likely to meet the H-1B specialty occupation standard.
How do I find medical devices H-1B sponsorship jobs in Indiana?
Migrate Mate is built specifically for international job seekers and filters medical devices H-1B sponsorship jobs in Indiana so you are not sifting through roles that do not offer visa support. You can browse verified listings from companies with H-1B sponsorship histories in Warsaw, Indianapolis, Bloomington, and other Indiana cities. Using a platform focused on sponsorship-confirmed roles saves significant time compared to general job searching.
Are there any Indiana-specific considerations for H-1B sponsorship in medical devices?
Indiana's medical device cluster, particularly around Warsaw, means many employers are mid-size specialty manufacturers rather than large multinational corporations. Mid-size companies can and do sponsor H-1B visas, but their HR infrastructure and familiarity with the process varies more than at large employers. It is worth researching a company's prior H-1B filing history through publicly available DOL LCA disclosure data before applying, to understand their sponsorship experience.
What is the prevailing wage for H-1B medical devices jobs in Indiana?
U.S. employers sponsoring a visa must pay at least the prevailing wage, which is what workers in the same role, area, and experience level typically earn. The Department of Labor sets this rate to make sure companies aren't hiring foreign workers simply because they'd accept lower pay than a U.S. worker. It varies by job title, location, and experience. You can look up current prevailing wage rates for any occupation and location using the OFLC Wage Search page.