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Medical Device Startup Jobs in Indiana (NOW HIRING)

CAI

Computer Systems Validation Engineer

Indianapolis, IN · On-site

$75K - $106K/yr

We provide commissioning, qualification, validation, startup, project management, and other ... medical device In-depth understanding of GAMP guidelines and FDA regulations (21 CFR 11, 210, 211 ...

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How much do medical device startup jobs pay per hour?

As of Jun 27, 2026, the average hourly pay for medical device startup in Indiana is $34.94, according to ZipRecruiter salary data. Most workers in this role earn between $23.56 and $43.70 per hour, depending on experience, location, and employer.

What is the difference between Medical Device Startup vs Medical Device Engineer?

AspectMedical Device StartupMedical Device Engineer
Required CredentialsTypically requires engineering degree, certifications varyRequires engineering degree, often with specific certifications in biomedical or mechanical engineering
Work EnvironmentFast-paced, innovative startup setting, often small teamsDesign, develop, and test medical devices, usually in corporate or R&D labs
Employer & Industry UsageStartups in medical device industry, early-stage companiesEstablished companies, R&D departments, or startups
Common Search & Comparison IntentUnderstanding roles in startups, career optionsJob responsibilities, qualifications, career path

Medical Device Startup roles focus on innovation, product development, and often require versatile skills in a dynamic environment. Medical Device Engineers are specialized professionals responsible for designing and testing devices, typically within established or startup companies. While both roles require engineering credentials, startups emphasize adaptability and entrepreneurial spirit, whereas engineers focus on technical expertise and product quality.

What is a medical device startup?

A medical device startup is a company in its early stages that focuses on developing, manufacturing, and bringing innovative medical devices to market. These startups often work on new technologies or improvements to existing devices, aiming to address unmet medical needs or improve patient outcomes. They typically operate in a high-regulation environment and may seek funding from investors, grants, or partnerships to support research, development, and commercialization efforts. Success in this field requires multidisciplinary expertise, including engineering, regulatory affairs, and clinical knowledge.

What are the key skills and qualifications needed to thrive in a medical device startup, and why are they important?

To thrive in a medical device startup, you need a solid background in biomedical engineering, product development, and regulatory compliance, often supported by relevant degrees or experience in healthcare technology. Familiarity with FDA regulations, CAD design software, and project management tools like Jira or Asana is typically required. Strong collaboration, adaptability, and entrepreneurial problem-solving are essential soft skills in this dynamic environment. These skills and qualities are vital for navigating rapid innovation cycles, ensuring regulatory approval, and driving successful product launches in a competitive market.

What Are Jobs at a Medical Device Startup?

Jobs at a medical device startup include roles in research and development, sales, information technology, software development, and customer service. Working at a medical device startup in research and development, you collaborate with teams to design studies, perform research, and devise training materials for products. Your end goal is to help develop new products. As a sales representative, you promote and sell medical equipment, educate clients on the benefits of products, and respond to questions and concerns. Software and IT jobs at a medical device startup involve responsibilities like troubleshooting technical problems, diagnosing and repairing computer systems, creating databases, evaluating processes, and maintaining and utilizing medical imaging equipment.

What are the common challenges faced when working in a medical device startup environment?

Working in a medical device startup often involves navigating a fast-paced, dynamic environment where priorities can shift rapidly. Team members typically wear multiple hats, balancing product development with strict regulatory requirements and limited resources. Collaboration across engineering, clinical, and business teams is essential, as everyone works together to meet ambitious milestones and bring innovative products to market. Despite these challenges, the role provides unique opportunities to make a tangible impact and grow professionally within a close-knit, innovative team.
More about Medical Device Startup jobs
What are the most commonly searched types of Medical Device Startup jobs in Indiana? The most popular types of Medical Device Startup jobs in Indiana are:
What are popular job titles related to Medical Device Startup jobs in Indiana? For Medical Device Startup jobs in Indiana, the most frequently searched job titles are:
What job categories do people searching Medical Device Startup jobs in Indiana look for? The top searched job categories for Medical Device Startup jobs in Indiana are:
Medical Device Startup jobs near you
Infographic showing various Medical Device Startup job openings in Indiana as of June 2026, with employment types broken down into 67% Full Time, 11% Part Time, and 22% Contract. Highlights an 83% Physical, 3% Hybrid, and 14% Remote job distribution, with an average salary of $72,685 per year, or $34.9 per hour.

Computer Systems Validation Engineer

CAI

Indianapolis, IN • On-site

$75K - $106K/yr

Full-time

Medical, Life, PTO

Posted 6 days ago

Job description

Are You Ready?
CAI is a professional services company established in 1996 that has grown to more than 700 people worldwide. We provide commissioning, qualification, validation, startup, project management, and other consulting services associated with operational readiness to FDA-regulated and other mission-critical industries.
Our approach is simple-we put the client's interests first, we don't stop until it's right, and we do whatever it takes to get there.
Our Foundational Principles:
- We act with integrity
- We serve each other
- We serve society
- We work for our future
We work diligently to accomplish team goals and live our core values:
- Team Before Self
- Respect for Others
- Can-Do Attitude
Key Responsibilities
Documentation & Compliance
Author GxP computer validation documentation (e.g., URS, FRS, RTM, summary reports)
Generate and execute test protocols and scripts
Ensure adherence to 21 CFR Part 11 and data integrity principles
Review and contribute to validation plans and risk assessments
System & Industry Expertise
Support CSV activities across various platforms including MES, DCS, SCADA, and batch systems
Engage with major systems and platforms such as Rockwell PharmaSuite, Rockwell Automation platforms, Emerson DeltaV, DeltaV Batch, Emerson Syncade, PI, GE, ABB, Siemens, Honeywell, PAS-X, FactoryTalk, FactoryLogix, PLM, Simatic, iFix, Wonderware
Apply knowledge of GAMP and compliance expectations (21 CFR Parts 210, 211, 11)
Utilize familiarity with S88/S95 batch control standards
Apply working knowledge of recipe authoring, batch recipe development, and S88-based recipe structures across systems such as DeltaV and Rockwell
Client Support & Technical Execution
Support client engagements with strong customer-service orientation
Perform system assessments and remediation related to data integrity
Collaborate with client teams to ensure validation compliance and delivery
Qualifications and Experience
Bachelor's degree (BS/BA) in Computer Science, Engineering, or related field; equivalent experience may be accepted
Minimum of 3+ years of experience in computer systems validation
Experience in biotech or pharmaceutical environments preferred over medical device
In-depth understanding of GAMP guidelines and FDA regulations (21 CFR 11, 210, 211)
Familiarity with S88/S95 batch control standards
Experience with Rockwell platforms, DeltaV systems, and recipe authoring in batch environments strongly preferred
Experience with multiple automation and manufacturing execution systems is highly desirable
Data integrity assessment/remediation experience is a plus
Other Requirements
- Excellent oral and written communication skills in English
- Ability to travel domestically and internationally as required
- Willingness to work paid overtime when needed
- Must be authorized to work in the U.S. without current or future sponsorship
Critical Competencies
Influence Strategy
- Pursues opportunities based on organizational fit and strategy
- Identifies high-impact, innovative solutions
Satisfy the Customer
- Anticipates and meets client needs
- Delivers high-quality solutions and maintains satisfaction
Plan for Success
- Aligns business goals with execution plans
- Allocates resources and builds risk mitigation strategies
Pursue Execution
- Prioritizes effectively and ensures accountability
- Proactively addresses challenges
Tailor Communication
- Communicates clearly and professionally
- Adapts style for technical and non-technical audiences
Build Partnerships
- Builds cross-functional networks
- Promotes collaboration and stakeholder engagement
Influence Others
- Gains support through sound reasoning
- Promotes innovation and value
Develop Self and Others
- Demonstrates integrity and commitment to growth
- Builds effective relationships internally and externally
#LI-MV1
$75,000 - $106,000 a year
Average base salary range - not including benefits, and potential overtime and/or Cost of Living Adjustment.
CAI Benefits:
• Comprehensive Health Insurance coverage
• 24 days of Paid Time Off
• Company paid Life Insurance
• Company paid Long Term Disability
We are an equal opportunity employer; we are proud to employ veterans and promote diversity and inclusion in our workplace. Diversity is a strength for our global company. We pledge that CAI will be operated in a way that is fair and equitable to all - our employees, our customers, and the broader society.
This job description is not all inclusive and you may be asked to do other duties. CAI will also consider for employment qualified applicants with criminal histories in a manner consistent with the requirements of the Fair Chance Act (FCA) / Fair Chance Ordinance (FCO).
We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses and identifying potential inconsistencies or verification signals in application materials based on available information. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.

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