Medical Devices OPT Jobs in Indiana
Indiana's medical devices sector spans Indianapolis, Warsaw, and Fort Wayne, with employers like Zimmer Biomet, Cook Medical, and DePuy Synthes regularly hiring international talent. F-1 OPT authorization lets you work in qualifying medical devices roles during your post-graduation period, making Indiana one of the more active states for this combination of visa type and industry.
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Get Access To All JobsQuality Engineer I
Position Summary
The Quality Engineer I will interact with team members to ensure compliance and internal and external customer requirements are met, with focus on quality engineering. This will be accomplished within Tecomet's principles of continuous improvement, customer driven innovation and a win first culture, while meeting company financial and other performance metrics.
Principle Responsibilities
- Maintaining applicable quality system, environmental, and FDA requirements/certifications.
- Facilitate operator owned quality program.
- Supporting the MRB and RMA processes.
- Work with team members and support manufacturing/operations to solve quality, cost and schedule issues.
- Prepare FMEA's, controls plans, quality plans, PPAP.
- Coordinate process validations and reduce dependence on inspection.
- Generating applicable quality metric reports; cost of quality, management by facts.
- Investigate customer complaints including associated actions including CAPA, deviations, and complaint responses.
- Special projects as assigned by quality management.
- Must demonstrate a working knowledge of standard manufacturing operations, FDA and ISO regulations.
- Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP) requirements.
- Standard problem-solving techniques.
- Applies statistical and Six Sigma concepts and techniques.
- Works with Internal and External Customers.
- Participates in audits and inspections.
Qualification Requirements
Credentials/Experience:
- Bachelor's Degree in Engineer or related field. Or a minimum of 4 years' experience within the Medical Device Industry, and Certification (ASQ CQE or CMQ/QE)
Experience/Educational/Training Preferred:
- ASQ CQE or CMQ/QE preferred
- 2 years' experience in quality within medical device manufacturing industry preferred
- ISO 13485, FDA 820 and customer interaction experience preferred
Knowledge, Skills, and Abilities:
- Manufacturing operations – forging and/or machining.
- Measuring devices.
- Quality Systems.
- Regulations – FDA, GMP and ISO.
- Blueprint reading.
- GD&T.
- Metrology.
- Problem solving and 8D.
- Math skills (algebra, trigonometry) skills.
- Microsoft office (Word, Excel, Outlook, PowerPoint).
- Minitab.
Work Environment
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Physical Requirements
The employee could frequently be required to walk; use hand to finger, handle, or feel; reach with hands and arms and talk or hear. The employee could be required to sit; climb or balance and stoop, kneel, crouch, or crawl. The employee could occasionally lift and or move up to 50 pounds. Specific vision abilities required by the job could include close vision, distance vision, peripheral vision and ability to adjust focus.
Travel Requirements
Up to 10%
Americans with Disabilities Act (ADA): Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Pay Transparency In order to support the Fair Compensation Strategy by the US Govt., HR Dept., clients are required to adhere to "Pay Transparency Law"; in the impacted states; that have mandated the employers to list the salary ranges in Job advertisements or postings for job opportunities and Job promotions.
Quality Engineer I
Position Summary
The Quality Engineer I will interact with team members to ensure compliance and internal and external customer requirements are met, with focus on quality engineering. This will be accomplished within Tecomet's principles of continuous improvement, customer driven innovation and a win first culture, while meeting company financial and other performance metrics.
Principle Responsibilities
- Maintaining applicable quality system, environmental, and FDA requirements/certifications.
- Facilitate operator owned quality program.
- Supporting the MRB and RMA processes.
- Work with team members and support manufacturing/operations to solve quality, cost and schedule issues.
- Prepare FMEA's, controls plans, quality plans, PPAP.
- Coordinate process validations and reduce dependence on inspection.
- Generating applicable quality metric reports; cost of quality, management by facts.
- Investigate customer complaints including associated actions including CAPA, deviations, and complaint responses.
- Special projects as assigned by quality management.
- Must demonstrate a working knowledge of standard manufacturing operations, FDA and ISO regulations.
- Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP) requirements.
- Standard problem-solving techniques.
- Applies statistical and Six Sigma concepts and techniques.
- Works with Internal and External Customers.
- Participates in audits and inspections.
Qualification Requirements
Credentials/Experience:
- Bachelor's Degree in Engineer or related field. Or a minimum of 4 years' experience within the Medical Device Industry, and Certification (ASQ CQE or CMQ/QE)
Experience/Educational/Training Preferred:
- ASQ CQE or CMQ/QE preferred
- 2 years' experience in quality within medical device manufacturing industry preferred
- ISO 13485, FDA 820 and customer interaction experience preferred
Knowledge, Skills, and Abilities:
- Manufacturing operations – forging and/or machining.
- Measuring devices.
- Quality Systems.
- Regulations – FDA, GMP and ISO.
- Blueprint reading.
- GD&T.
- Metrology.
- Problem solving and 8D.
- Math skills (algebra, trigonometry) skills.
- Microsoft office (Word, Excel, Outlook, PowerPoint).
- Minitab.
Work Environment
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Physical Requirements
The employee could frequently be required to walk; use hand to finger, handle, or feel; reach with hands and arms and talk or hear. The employee could be required to sit; climb or balance and stoop, kneel, crouch, or crawl. The employee could occasionally lift and or move up to 50 pounds. Specific vision abilities required by the job could include close vision, distance vision, peripheral vision and ability to adjust focus.
Travel Requirements
Up to 10%
Americans with Disabilities Act (ADA): Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Pay Transparency In order to support the Fair Compensation Strategy by the US Govt., HR Dept., clients are required to adhere to "Pay Transparency Law"; in the impacted states; that have mandated the employers to list the salary ranges in Job advertisements or postings for job opportunities and Job promotions.
OPT Medical Devices Job Roles in Indiana
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Search Medical Devices Jobs in IndianaMedical Devices OPT Sponsorship Jobs in Indiana: Frequently Asked Questions
Which medical devices companies in Indiana sponsor F-1 OPT workers?
Indiana is home to several large medical devices employers with established international hiring track records. Zimmer Biomet and DePuy Synthes are headquartered in or near Warsaw, while Cook Medical operates out of Bloomington. Stryker and Medtronic also maintain Indiana operations. F-1 OPT sponsorship is not guaranteed at any of these companies, but their size and history of international hiring make them worth researching directly.
Which cities in Indiana have the most medical devices F-1 OPT sponsorship jobs?
Warsaw is often called the orthopedic capital of the world and concentrates a significant share of Indiana's medical devices employment, particularly in orthopedics and surgical implants. Indianapolis offers broader opportunities across device manufacturing, quality, and regulatory functions. Bloomington hosts Cook Medical's headquarters. Fort Wayne and South Bend also have medical devices operations, though at smaller scale than Warsaw or Indianapolis.
What types of medical devices roles typically qualify for F-1 OPT sponsorship in Indiana?
Roles that align with your degree field are the relevant consideration for OPT eligibility. Common qualifying positions include quality engineering, regulatory affairs, manufacturing engineering, R&D engineering, clinical applications, and software development for medical devices. Roles in biomedical engineering, mechanical engineering, and electrical engineering frequently appear with Indiana employers. The position must be directly related to your field of study for OPT authorization to apply.
How do I find medical devices F-1 OPT sponsorship jobs in Indiana?
Migrate Mate is built specifically for international students and filters jobs by visa type and industry, making it straightforward to search for medical devices F-1 OPT roles in Indiana without sorting through postings that don't apply to your situation. Beyond Migrate Mate, targeting Warsaw-area employers directly and attending industry events like the Indiana Medical Device Manufacturers Council programs can surface opportunities that aren't always broadly advertised.
Are there any Indiana-specific considerations for F-1 OPT in medical devices?
Indiana's medical devices concentration in Warsaw means many employers are mid-size or specialized firms rather than large multinationals, which can affect how formal their international hiring processes are. Some smaller device companies may be less familiar with OPT paperwork requirements. It's worth confirming early in the application process that a prospective employer understands OPT work authorization, including STEM OPT extension eligibility if your degree qualifies, before accepting an offer.