Medical Devices Visa Sponsorship Jobs in Indiana
Indiana's medical devices industry centers around Indianapolis and Bloomington, with major employers including Cook Medical, Zimmer Biomet, and Boston Scientific sponsoring international talent. The state's strong life sciences infrastructure and proximity to research universities create opportunities for engineers, regulatory specialists, and quality professionals seeking visa sponsorship.
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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.
Medical Devices Job Roles in Indiana
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Search Medical Devices Jobs in IndianaMedical Devices Jobs in Indiana: Frequently Asked Questions
Which medical devices companies sponsor visas in Indiana?
Major sponsors include Cook Medical (Bloomington), Zimmer Biomet (Warsaw), Boston Scientific (Indianapolis), Roche Diagnostics (Indianapolis), and Endocyte (West Lafayette). These companies regularly file H-1B visa petitions for biomedical engineers, regulatory affairs specialists, quality assurance managers, and research scientists. Many also sponsor L-1 visa transfers for experienced professionals from international offices.
Which cities in Indiana have the most medical devices sponsorship jobs?
Indianapolis leads with the highest concentration, hosting Boston Scientific, Roche Diagnostics, and numerous smaller med-tech firms. Warsaw follows as the orthopedic capital, home to Zimmer Biomet and DePuy Synthes. Bloomington offers opportunities with Cook Medical, while West Lafayette benefits from Purdue University's bioengineering research connections to local startups.
How to find medical devices visa sponsorship jobs in Indiana?
Use Migrate Mate to filter specifically for medical devices positions in Indiana that offer visa sponsorship. The platform shows verified sponsoring employers like Cook Medical and Zimmer Biomet, along with application requirements and visa types. Focus on roles in regulatory affairs, biomedical engineering, and quality systems where companies actively recruit international talent.
Which visa types are most common for medical devices roles in Indiana?
H-1B dominates for specialized positions like biomedical engineers, regulatory affairs specialists, and clinical research associates. O-1 visas are used for senior scientists with exceptional achievements in medical device innovation. L-1 transfers are common at multinational companies like Boston Scientific and Roche, bringing experienced professionals from European or Asian divisions.
What makes Indiana attractive for international medical devices professionals?
Indiana offers lower living costs compared to coastal biotech hubs, with strong industry clusters in orthopedics (Warsaw) and general medical devices (Indianapolis). The state's central location provides easy access to major markets, while partnerships between companies like Cook Medical and Indiana University create pathways for international students transitioning to sponsored employment.
What is the prevailing wage for sponsored 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.