ZipRecruiter

Log In

1

Manager Medical Device Software Engineer Jobs in Indiana

Brooksource

Software Quality Engineer

Indianapolis, IN · On-site

$55 - $64/hr

Support the design, development, and testing of medical device software, including Software as a ... Review test case execution results and manage software defects * Facilitate software risk ...

Hearst

Medical Device Coder

Indianapolis, IN · On-site

$18 - $24/hr

S. health plans, retail pharmacies, and pharmacy benefit managers; and millions of healthcare ... Partnering with our information system developer and healthcare institution customers, you'll help ...

Hearst

Medical Device Coder

Carmel, IN · On-site

$17.75 - $23.75/hr

S. health plans, retail pharmacies, and pharmacy benefit managers; and millions of healthcare ... Partnering with our information system developer and healthcare institution customers, you'll help ...

Hearst Newspapers

Medical Device Coder

Indianapolis, IN · On-site

$18 - $24/hr

S. health plans, retail pharmacies, and pharmacy benefit managers; and millions of healthcare ... Partnering with our information system developer and healthcare institution customers, you'll help ...

Hearst UK

Medical Device Coder

Indianapolis, IN · On-site

$18 - $24/hr

S. health plans, retail pharmacies, and pharmacy benefit managers; and millions of healthcare ... Partnering with our information system developer and healthcare institution customers, you'll help ...

Hearst

Medical Device Coder

Carmel, IN · On-site

$17.75 - $23.75/hr

S. health plans, retail pharmacies, and pharmacy benefit managers; and millions of healthcare ... Partnering with our information system developer and healthcare institution customers, you'll help ...

Hearst

Medical Device Coder

Carmel, IN · On-site

$17.75 - $23.75/hr

S. health plans, retail pharmacies, and pharmacy benefit managers; and millions of healthcare ... Partnering with our information system developer and healthcare institution customers, you'll help ...

Hearst Health

Medical Device Coder

Carmel, IN · On-site

$18.50 - $24.75/hr

S. health plans, retail pharmacies, and pharmacy benefit managers; and millions of healthcare ... Partnering with our information system developer and healthcare institution customers, you'll help ...

Hearst Health

Medical Device Coder

Indianapolis, IN · On-site

$18 - $24/hr

S. health plans, retail pharmacies, and pharmacy benefit managers; and millions of healthcare ... Partnering with our information system developer and healthcare institution customers, you'll help ...

First Databank

Medical Device Coder

Indianapolis, IN · On-site

$18 - $24/hr

S. health plans, retail pharmacies, and pharmacy benefit managers; and millions of healthcare ... Partnering with our information system developer and healthcare institution customers, you'll help ...

Hearst

Medical Device Coder

Carmel, IN · On-site

$18.50 - $24.75/hr

S. health plans, retail pharmacies, and pharmacy benefit managers; and millions of healthcare ... Partnering with our information system developer and healthcare institution customers, you'll help ...

Hearst Communications, Inc.

Medical Device Coder

Carmel, IN · On-site

$17.75 - $23.75/hr

S. health plans, retail pharmacies, and pharmacy benefit managers; and millions of healthcare ... Partnering with our information system developer and healthcare institution customers, you'll help ...

Hearst Health

Medical Device Coder

Carmel, IN · On-site

$17.75 - $23.75/hr

S. health plans, retail pharmacies, and pharmacy benefit managers; and millions of healthcare ... Partnering with our information system developer and healthcare institution customers, you'll help ...

next page

Showing results 1-20

All JobsMedical Device Software Engineer JobsManager Medical Device Software Engineer JobsManager Medical Device Software Engineer Jobs in Indiana

Manager Medical Device Software Engineer information

What does a manager medical device software engineer do?

A Manager Medical Device Software Engineer oversees teams that design, develop, and maintain software for medical devices. They ensure that the software complies with regulatory standards, works reliably, and meets the needs of healthcare professionals and patients. In addition to technical leadership, they coordinate with cross-functional teams, manage project timelines, and mentor engineers. Their role is critical in ensuring products are both safe and effective for use in medical settings.

How does a manager medical device software engineer typically collaborate with cross-functional teams during product development?

A Manager Medical Device Software Engineer frequently works alongside teams such as regulatory affairs, quality assurance, hardware engineering, clinical specialists, and marketing. They coordinate software development activities to ensure compliance with industry standards and regulatory requirements, while also aligning software features with clinical and business needs. These managers often lead design reviews, facilitate risk assessments, and ensure effective communication between software engineers and non-technical stakeholders. This collaborative environment is essential for delivering safe, effective, and user-friendly medical devices.

What are the key skills and qualifications needed to thrive as a manager medical device software engineer, and why are they important?

To thrive as a Manager Medical Device Software Engineer, you need expertise in software development, medical device regulations (such as FDA or ISO 13485), and a background in engineering or computer science, often supported by advanced degrees or certifications. Familiarity with tools like version control systems (e.g., Git), embedded systems platforms, and quality management software is essential, along with understanding regulatory documentation processes. Strong leadership, effective communication, and problem-solving abilities distinguish top performers in this role. These skills are crucial for ensuring safe, compliant, and innovative medical device software development while leading teams to deliver high-quality products.

What are the most commonly searched types of Medical Device Software Engineer jobs in Indiana?

The most popular types of Medical Device Software Engineer jobs in Indiana are:

What are popular job titles related to Manager Medical Device Software Engineer jobs in Indiana?

For Manager Medical Device Software Engineer jobs in Indiana, the most frequently searched job titles are:

What job categories do people searching Manager Medical Device Software Engineer jobs in Indiana look for?

The top searched job categories for Manager Medical Device Software Engineer jobs in Indiana are:

What cities in Indiana are hiring for Manager Medical Device Software Engineer jobs?

Cities in Indiana with the most Manager Medical Device Software Engineer job openings:

Manager Medical Device Software Engineer jobs near you

Software Quality Engineer

Brooksource

Indianapolis, IN • On-site

$55 - $64/hr

Contractor

Medical, Dental, Vision, Retirement, PTO

Posted 12 days ago

Job description

Software Quality Engineer
Warsaw, IN
Hybrid role (3 days in office)
$55 - $64 per hour
ABOUT THE ROLE
Join a Fortune 50 Life Sciences company as a Software Quality Engineer, providing quality leadership for a new product project team focused on the development of medical device software systems. In this hybrid role based in Warsaw, IN, you will serve as the subject matter expert in requirements gathering, software risk assessments, test strategy definition, and guiding the team on design controls and defect analysis. You will partner closely with R&D throughout the full development lifecycle-from upstream requirements and risk through mid-stream verification to ongoing compliance and audit readiness. This is a high-visibility opportunity to own quality end-to-end, gain exposure to a full medical device software toolchain, and collaborate cross-functionally with business partners and mentors.
WHAT YOU'LL DO
  • Support the design, development, and testing of medical device software, including Software as a Medical Device (SaMD) products
  • Provide leadership, guidance, and expertise on software development processes, procedures, and practices
  • Serve as a subject matter expert in requirements gathering, test strategy definition, and design controls
  • Facilitate documentation and tracking of verification activities, including code review findings
  • Review test case execution results and manage software defects
  • Facilitate software risk assessment sessions and own the development of risk documentation
  • Support regulatory filings and registrations, including 510(k) submissions and Design History File (DHF) creation
  • Provide technical support for audits of software suppliers and consultants, including cybersecurity and threat modeling topics
  • Conduct training on medical device software development processes and quality systems; develop associated work instructions
  • Provide expertise in applicable industry standards and regulations (e.g., IEC 62304, FDA guidance, FDA Part 11, ISO 13485, EU MDR, ISO 14971, IEC 62366, ISO 27001, HIPAA)
  • Collaborate closely with R&D and cross-functional teams to ensure compliance with industry standards and regulatory requirements

WHAT YOU BRING
  • Bachelor's degree or university degree in Engineering, Computer Science, Information Systems, or Biomedical/Bio-engineering (required)
  • Minimum 4 years of regulated industry experience in quality, new product development, or manufacturing engineering
  • Experience in the medical device industry
  • Proficiency with quality tools, systems, and processes (e.g., Windchill, Polarion, ETQ)
  • Strong interpersonal, organizational, and verbal/written communication skills
  • Ability to work collaboratively in a team environment and demonstrate leadership
  • Ability to perform duties in accordance with company policies, procedures, and civil rights requirements
  • ASQ Certification as a Software Quality Engineer or equivalent (preferred)
  • Expertise in applicable industry standards and regulations (e.g., IEC 62304, FDA guidance, FDA Part 11, ISO 13485, EU MDR, ISO 14971, IEC 62366, ISO 27001, HIPAA)
  • Experience supporting regulatory filings and registrations (e.g., 510(k) submissions, DHF creation)
  • Ability to facilitate software risk assessments and develop risk documentation

WHAT'S IN IT FOR YOU
  • Opportunity to own quality end-to-end on a high-visibility project for a Fortune 50 Life Sciences company
  • Exposure to a full medical device software toolchain (Windchill, Polarion, ETQ) and hands-on involvement
  • Meaningful mentorship scope and cross-collaborative team and business partners
  • Hybrid work environment (3 days in office)

Disclaimer: Brooksource, Medasource, and Calculated Hire are part of the Eight Eleven Group family of companies and operate under Eight Eleven Group, LLC. All employees receive the same benefits, policies, and terms of employment.
EEO:
We are committed to creating an inclusive environment for all employees and applicants. We do not discriminate on the basis of race, color, religion, creed, sex, sexual orientation, gender identity or expression, national origin, ancestry, age, disability, genetic information, marital status, military or veteran status, citizenship, pregnancy (including childbirth, lactation, and related conditions), or any other protected status in accordance with applicable federal, state, and local laws.
Benefits & Perks:
Brooksource offers competitive medical, dental, vision, Health Savings Account, Dependent Care FSA, and supplemental coverage with plans that can fit each employee's needs. We offer a 401k plan that includes a company match and is fully vested after you become eligible, paid time off, sick time, and paid company holidays. We also offer an Employee Assistance Program (EAP) that provides services like virtual counseling, financial services, legal services, life coaching, etc.
Pay Disclaimer:
The pay range for this job level is a general guideline only and not a guarantee of compensation or salary. Additional factors considered in extending an offer include (but are not limited to) responsibilities of the job, education, experience, knowledge, skills, and abilities, as well as internal equity, alignment with market data, applicable bargaining agreement (if any), or other law.

Apply