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Medical Device Product Development Manager Jobs in Indiana

Marmon

NEW PRODUCT INTRODUCTION (NPI) MANAGER

Angola, IN · On-site

$157K - $162K/yr

The ideal candidate will have strong experience in medical device product development, manufacturing operations, project management, and cross-functional leadership within a regulated environment.

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 ... Productive. Committed. Willing and able to go above and beyond. Passionate about making a ...

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 ... Productive. Committed. Willing and able to go above and beyond. Passionate about making a ...

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 ... Productive. Committed. Willing and able to go above and beyond. Passionate about making a ...

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 ... Productive. Committed. Willing and able to go above and beyond. Passionate about making a ...

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 ... Productive. Committed. Willing and able to go above and beyond. Passionate about making a ...

Hearst Newspapers

Medical Device Coder

Indianapolis, IN

$18 - $24/hr

S. health plans, retail pharmacies, and pharmacy benefit managers; and millions of healthcare ... Productive. Committed. Willing and able to go above and beyond. Passionate about making a ...

Hearst

Medical Device Coder

Carmel, IN

$17.75 - $23.75/hr

S. health plans, retail pharmacies, and pharmacy benefit managers; and millions of healthcare ... Productive. Committed. Willing and able to go above and beyond. Passionate about making a ...

First Databank

Medical Device Coder

Carmel, IN

$17.75 - $23.75/hr

S. health plans, retail pharmacies, and pharmacy benefit managers; and millions of healthcare ... Productive. Committed. Willing and able to go above and beyond. Passionate about making a ...

VOLT

Medical Device Assembler

Carmel, IN · On-site

$20 - $23/hr

Accurately complete paper and electronic documentation to maintain full product traceability and ... Prior experience as a Medical Device Assembler or Production Assembler is required * Ability to ...

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All JobsMedical Device Product Development JobsMedical Device Product Development Manager JobsMedical Device Product Development Manager Jobs in Indiana

Medical Device Product Development Manager information

See Indiana salary details

$38K

$121.1K

$138.5K

How much do medical device product development manager jobs pay per year?

As of Aug 4, 2026, the average yearly pay for medical device product development manager in Indiana is $121,130.00, according to ZipRecruiter salary data. Most workers in this role earn between $109,600.00 and $137,500.00 per year, depending on experience, location, and employer.

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

To thrive as a Medical Device Product Development Manager, you need expertise in engineering or life sciences, experience with product lifecycle management, and knowledge of regulatory requirements, often supported by a relevant degree. Familiarity with CAD software, project management tools, and compliance systems such as ISO 13485 or FDA regulations is typically required. Strong leadership, cross-functional communication, and problem-solving skills help drive innovation and align diverse teams. These competencies are vital to ensure products are developed efficiently, safely, and in compliance with industry standards.

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

A Medical Device Product Development Manager works closely with cross-functional teams, including engineering, regulatory affairs, quality assurance, marketing, and clinical experts, to ensure that product requirements are met throughout each development phase. They facilitate regular meetings to align on project milestones, address potential risks, and incorporate feedback from various stakeholders. This collaborative environment helps ensure that the final product complies with regulatory standards and meets market needs, making strong communication and project management skills essential in this role.

What is the difference between Medical Device Product Development Manager vs Medical Device Quality Assurance Specialist?

AspectMedical Device Product Development ManagerMedical Device Quality Assurance Specialist
CredentialsEngineering degree, certifications like PMP or PDMAQuality assurance certifications like CQE, ISO auditor
Work EnvironmentDesign teams, R&D, cross-functional project groupsQuality labs, compliance departments, manufacturing oversight
Industry UsageLeading product development from concept to launchEnsuring products meet quality and regulatory standards

The Medical Device Product Development Manager focuses on designing and developing new medical devices, managing cross-functional teams, and bringing products to market. In contrast, the Medical Device Quality Assurance Specialist ensures that products meet quality standards and regulatory requirements throughout the development and manufacturing process. Both roles are essential in the medical device industry but serve different functions in product lifecycle management.

What does a medical device product development manager do?

A Medical Device Product Development Manager oversees the entire process of bringing a medical device from the concept stage to market launch. They coordinate cross-functional teams, manage timelines, ensure compliance with regulatory standards, and oversee testing and validation of products. Their responsibilities also include working with engineers, designers, and regulatory specialists to ensure the device meets safety, efficacy, and user needs. Ultimately, they play a critical role in ensuring that new medical devices are developed efficiently, safely, and in compliance with industry standards.
What cities in Indiana are hiring for Medical Device Product Development Manager jobs? Cities in Indiana with the most Medical Device Product Development Manager job openings:
Medical Device Product Development Manager jobs near you

Design Quality Engineer

Prophecy Technologies

Indianapolis, IN • On-site, Remote

Full-time

Posted 7 days ago

Job description

Role Overview:
The Design Quality Engineer will play a crucial role in supporting quality activities throughout the medical device product development lifecycle. This position requires a strong understanding of Design Control requirements and regulatory standards such as FDA 21 CFR Part 820, ISO 13485, and ISO 14971, ensuring compliance and maintaining Design History File (DHF) documentation and risk management processes.
Key Responsibilities:
  • Support quality activities throughout the product development lifecycle.
  • Review and maintain Design History File (DHF) documentation for compliance with regulatory and quality requirements.
  • Lead and support risk management activities including dFMEA, uFMEA, and PHA updates.
  • Ensure traceability between User Needs, Design Inputs, Risk Controls, Verification, Validation, and Design Outputs.
  • Support Design Verification and Validation planning, execution, and documentation reviews.
  • Review Product Characterization, Product Specification (PSD), and CTQ documents.
  • Participate in design reviews and ensure compliance with Design Control processes.
  • Support Cockpit Cognition DHF Build activities, including documentation organization and traceability linkages.
  • Conduct DHF gap assessments and support remediation activities.
  • Collaborate with R&D, Manufacturing, Regulatory Affairs, and Supplier Quality teams.
  • Support CAPA investigations, root cause analysis, and implementation of corrective actions.
  • Ensure compliance with FDA, ISO 13485, ISO 14971, and internal quality procedures.
  • Support internal audits, customer audits, and regulatory inspections.
  • Drive continuous improvement initiatives related to design quality and risk management processes.

Required Skills:
  • Strong understanding of Medical Device Product Development Process and Design Control requirements.
  • Knowledge of FDA 21 CFR Part 820, ISO 13485, ISO 14971, and applicable regulatory standards.
  • Strong knowledge of Design Controls and medical device product development.
  • Experience with Design History File (DHF) development, review, and remediation.
  • Hands-on experience with Risk Management activities including: dFMEA, uFMEA, Preliminary Hazard Analysis (PHA).
  • Experience with Design Verification and Validation (V&V).
  • Understanding of User Needs, Design Inputs, Design Outputs, and Traceability requirements.
  • Experience preparing and reviewing: Product Specification Documents (PSD), Product Characterization documents, CTQ (Critical-to-Quality) documents.
  • Experience with CAPA, Nonconformance, and root cause investigations.
  • Familiarity with PLM systems such as Windchill or Teamcenter.
  • Experience with Cockpit Cognition DHF Build and DHF traceability management.
  • Strong documentation, technical writing, and audit support skills.

Qualifications:
  • Strong understanding of Medical Device Product Development Process and Design Control requirements.
  • Knowledge of FDA 21 CFR Part 820, ISO 13485, ISO 14971, and applicable regulatory standards.

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