Medical Devices STEM OPT Jobs in Indiana
Indiana's medical devices sector spans Zimmer Biomet's headquarters in Warsaw, Cook Medical in Bloomington, and Roper Technologies facilities across the state, creating consistent demand for engineers, regulatory specialists, and quality professionals. F-1 students on STEM OPT can fill 24-month work authorization extensions at companies with established E-Verify programs and active sponsorship histories in this manufacturing-strong state.
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Get Access To All JobsDescription: The primary purpose of this job is to provide Quality Engineering support for Operations to ensure that the Quality System requirements are adhered to for medical device manufacturing/operations in accordance with applicable Regulatory and Standards requirements for compliance. Independent contributor.
Responsibilities:
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Adheres to Viant Core Beliefs and all safety and quality requirements including, but not limited to: Quality Management Systems (QMS), Environmental Management Systems (EMS), U.S. Food and Drug Administration (FDA) regulations, Company policies and operating procedures, and other regulatory requirements.
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Supports regulatory and agency inspections, audits, investigations, and inquiries regarding the control and assessment of product design and manufacturing quality.
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Monitors manufacturing of assigned products, assuring compliance with DMR while providing deviation/waiver guidance and assuring complete and correct Device History Records are maintained.
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Implements various product and process improvement methodologies.
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Review the adequacy and correctness of changes to Bill of Materials (BOM’s), Assembly Procedures, Drawings, Component Specification, FMEAs, Control Plans, etc.
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Maintains risk analyses.
-
Completes protocols and reports for test method validation.
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Interfaces with Manufacturing Engineers to review processes for new and existing products and coordinate process validations and capability studies. Recommends process monitoring devices where applicable.
-
Develops various inspection techniques and procedures to ensure product integrity to design specifications. Responsible for the writing, approval and implementation of Incoming, In-Process and Final Inspection procedures.
-
Ensures that the disposition of non-conforming materials meet all necessary regulatory requirements and assure adequacy of corrective actions to prevent re-occurrence.
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Effectively communicate and interact with customers.
-
Completes complaint investigations.
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Executes plant CAPA activities, including analysis of data and trends in complaints, supplier quality, nonconforming material, training effectiveness, and root causes analysis.
-
Assists with product transfers.
-
Works with suppliers, management, Engineers and Manufacturing associates in the resolution of quality problems. Also, executes capability studies and applies statistical quality control which includes Cpk, DOE, Hypotheses Testing, etc.
-
Coordinates the preparation of Quality Plans, including inspection, test and gauge requirements for new product introductions.
-
Provides support to other quality engineers.
-
Performs other functions as required.
-
Manage a heavy workload while maintaining accuracy.
-
Identify potential roadblocks and provide innovative solutions.
-
Operate with a high level of integrity and professionalism.
-
Committed to and accountable for achieving goals and objectives.
Requirements:
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Education/Certification: Bachelor’s Degree in Engineering or related field required or 2 – 5 years of experience working in a quality engineering role within a regulated industry.
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Experience: 0-2 years’ experience in medical device or regulated manufacturing.
-
Skills/Competencies:
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Ability to multitask and drive initiatives to completion.
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Competence in the selection and use of Quality Engineering Tools and Techniques.
-
Strong communication skills and ability to align with key stakeholders.
-
Strong working knowledge in the interpretation and application of relevant Domestic and International Regulations and Industry Standards (e.g. FDA 21CRF820, ISO 13485:2016; MDSAP; ISO14971, QSR, MDD, TGA etc.).
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Proficient in Microsoft Office and Minitab.
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Physical Requirements:
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Light work: Exerting up to 20 pounds of force occasionally, and/or up to 10 pounds of force frequently, and/or lift, carry, push, pull, or move objects.
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Visual Acuity: Close vision.
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Travel: Less than 10%.
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Equipment Used: N/A.
Work Conditions:
- Worker is not exposed to adverse environmental conditions.
Description: The primary purpose of this job is to provide Quality Engineering support for Operations to ensure that the Quality System requirements are adhered to for medical device manufacturing/operations in accordance with applicable Regulatory and Standards requirements for compliance. Independent contributor.
Responsibilities:
-
Adheres to Viant Core Beliefs and all safety and quality requirements including, but not limited to: Quality Management Systems (QMS), Environmental Management Systems (EMS), U.S. Food and Drug Administration (FDA) regulations, Company policies and operating procedures, and other regulatory requirements.
-
Supports regulatory and agency inspections, audits, investigations, and inquiries regarding the control and assessment of product design and manufacturing quality.
-
Monitors manufacturing of assigned products, assuring compliance with DMR while providing deviation/waiver guidance and assuring complete and correct Device History Records are maintained.
-
Implements various product and process improvement methodologies.
-
Review the adequacy and correctness of changes to Bill of Materials (BOM’s), Assembly Procedures, Drawings, Component Specification, FMEAs, Control Plans, etc.
-
Maintains risk analyses.
-
Completes protocols and reports for test method validation.
-
Interfaces with Manufacturing Engineers to review processes for new and existing products and coordinate process validations and capability studies. Recommends process monitoring devices where applicable.
-
Develops various inspection techniques and procedures to ensure product integrity to design specifications. Responsible for the writing, approval and implementation of Incoming, In-Process and Final Inspection procedures.
-
Ensures that the disposition of non-conforming materials meet all necessary regulatory requirements and assure adequacy of corrective actions to prevent re-occurrence.
-
Effectively communicate and interact with customers.
-
Completes complaint investigations.
-
Executes plant CAPA activities, including analysis of data and trends in complaints, supplier quality, nonconforming material, training effectiveness, and root causes analysis.
-
Assists with product transfers.
-
Works with suppliers, management, Engineers and Manufacturing associates in the resolution of quality problems. Also, executes capability studies and applies statistical quality control which includes Cpk, DOE, Hypotheses Testing, etc.
-
Coordinates the preparation of Quality Plans, including inspection, test and gauge requirements for new product introductions.
-
Provides support to other quality engineers.
-
Performs other functions as required.
-
Manage a heavy workload while maintaining accuracy.
-
Identify potential roadblocks and provide innovative solutions.
-
Operate with a high level of integrity and professionalism.
-
Committed to and accountable for achieving goals and objectives.
Requirements:
-
Education/Certification: Bachelor’s Degree in Engineering or related field required or 2 – 5 years of experience working in a quality engineering role within a regulated industry.
-
Experience: 0-2 years’ experience in medical device or regulated manufacturing.
-
Skills/Competencies:
-
Ability to multitask and drive initiatives to completion.
-
Competence in the selection and use of Quality Engineering Tools and Techniques.
-
Strong communication skills and ability to align with key stakeholders.
-
Strong working knowledge in the interpretation and application of relevant Domestic and International Regulations and Industry Standards (e.g. FDA 21CRF820, ISO 13485:2016; MDSAP; ISO14971, QSR, MDD, TGA etc.).
-
Proficient in Microsoft Office and Minitab.
-
Physical Requirements:
-
Light work: Exerting up to 20 pounds of force occasionally, and/or up to 10 pounds of force frequently, and/or lift, carry, push, pull, or move objects.
-
Visual Acuity: Close vision.
-
Travel: Less than 10%.
-
Equipment Used: N/A.
Work Conditions:
- Worker is not exposed to adverse environmental conditions.
STEM OPT Medical Devices Job Roles in Indiana
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Search Medical Devices Jobs in IndianaMedical Devices STEM OPT Sponsorship Jobs in Indiana: Frequently Asked Questions
Which medical devices companies in Indiana sponsor F-1 STEM OPT visas?
Indiana is home to several medical devices employers with documented sponsorship activity, including Zimmer Biomet in Warsaw, Cook Medical in Bloomington, and DePuy Synthes operations connected to the state's orthopedics corridor. Larger manufacturers and contract research organizations with E-Verify enrollment are generally the most active sponsors, since STEM OPT requires the employer to be enrolled in E-Verify as a federal compliance requirement.
Which Indiana cities have the most medical devices F-1 STEM OPT sponsorship jobs?
Warsaw consistently stands out as Indiana's orthopedic devices capital, often called the 'ortho capital of the world,' concentrating manufacturing and R&D roles that align with STEM OPT-eligible degree fields. Indianapolis has a growing med-tech presence through hospital system suppliers and diagnostics companies. Bloomington and Columbus also host device manufacturers with engineering and quality assurance openings that commonly appear in STEM OPT sponsorship filings.
What types of medical devices roles typically qualify for F-1 STEM OPT sponsorship in Indiana?
Roles that qualify must require a STEM-designated degree as a substantive part of the job. In Indiana's medical devices sector, this commonly includes biomedical engineering, quality systems engineering, regulatory affairs, manufacturing process engineering, and R&D positions in biomaterials or implant design. Roles classified under STEM degree classifications tied to engineering, life sciences, or computer and mathematical occupations are the clearest fits for STEM OPT extension eligibility under USCIS guidelines.
How do I find medical devices F-1 STEM OPT sponsorship jobs in Indiana?
Migrate Mate filters medical devices job listings specifically by visa sponsorship type, so you can search for Indiana roles that employers have flagged as open to F-1 STEM OPT candidates. Because STEM OPT requires E-Verify enrollment, Migrate Mate's data surfaces employers who meet that baseline requirement. Focusing your search on Warsaw, Indianapolis, and Bloomington will target the highest concentrations of active medical devices sponsors in the state.
Are there any Indiana-specific considerations for F-1 STEM OPT sponsorship in medical devices?
Indiana's medical devices industry is heavily concentrated in manufacturing and orthopedics, so many roles involve regulated production environments subject to FDA quality system requirements. Employers in this space often conduct background checks tied to federal contractor status, which can affect hiring timelines. Indiana does not impose additional state-level work authorization requirements beyond federal USCIS and DOL rules, but students should confirm their I-983 training plan is finalized with their DSO before starting any STEM OPT-authorized role.