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Medical Device Product Development Manager Jobs in Indiana

Qualtronics

PRODUCT DEVELOPMENT

Columbus, IN · On-site

$106K - $133K/yr

... Manage Part Approval process · Maintain accurate paperwork and job files electronically and ... of product line and pricing · Strong working knowledge of PC and Microsoft Office · Customer ...

Red Star

Senior Sterile Packaging Engineer

Larwill, IN · On-site

... for the medical device industry. From concept through high-volume production, our teams work ... This role partners cross-functionally with Regulatory, Product Development, Operations, Supply ...

Qualtronics

PRODUCT DEVELOPMENT

Columbus, IN · On-site

$106K - $133K/yr

... Manage Part Approval process Maintain accurate paperwork and job files electronically and ... product line and pricing Strong working knowledge of PC and Microsoft Office Customer service ...

Qualtronics

PRODUCT DEVELOPMENT

Columbus, IN · On-site

$106K - $133K/yr

... designs • Manage Part Approval process • Maintain accurate paperwork and job files ... product line and pricing • Strong working knowledge of PC and Microsoft Office • Customer ...

Red Star

Senior Sterile Packaging Engineer

IN · On-site

... for the medical device industry. From concept through high-volume production, our teams work ... This role partners cross-functionally with Regulatory, Product Development, Operations, Supply ...

Red Star

Senior Sterile Packaging Engineer

Larwill, IN · On-site

$85 - $110/hr

... for the medical device industry. From concept through high-volume production, our teams work ... This role partners cross-functionally with Regulatory, Product Development, Operations, Supply ...

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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 22, 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 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.

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 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.

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 is medical device product development?

Medical device product development involves designing, testing, and bringing new medical devices to market, ensuring they meet safety and regulatory standards. A Medical Device Product Development Manager oversees this process, coordinating cross-functional teams, managing timelines, and ensuring compliance with industry regulations such as FDA or ISO 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

Senior R&D Engineer - MediTech (Mitsubishi Chemical Advanced Materials)

Mitsubishi Chemical Corporation

Fort Wayne, IN • On-site, Remote

Full-time

Posted 12 days ago

Mitsubishi Chemical rating

8.6

Company rating: 8.6 out of 10

Based on 25 frontline employees who took The Breakroom Quiz

16th of 100 rated chemical manufacturers

Job description

Company:
Mitsubishi Chemical Advanced Materials Inc.
Job Description:
Are you an experienced R&D engineer with a passion for medical innovation and implantable materials? Mitsubishi Chemical Advanced Materials is seeking a Senior R&D Engineer to join our MediTECH Division, where you'll help develop the next generation of orthopedic implant materials and manufacturing technologies.
This is a highly technical, customer-facing leadership role that combines research, product development, project management, and process engineering. You'll lead new product and process development from concept through commercialization while collaborating with customers, suppliers, and cross-functional teams to bring innovative medical device solutions to market. If you're driven by solving complex engineering challenges and advancing healthcare technologies, we'd love to hear from you.
What You'll Do
Lead New Product & Process Development
  • Lead research and development projects from concept through commercialization
  • Develop innovative implantable material solutions for orthopedic surgical applications
  • Design, execute, and document product and process development trials using laboratory and production equipment
  • Evaluate new technologies, manufacturing methods, and materials that support business growth
  • Prepare process, manufacturing, cost, and economic models to support new product initiatives
Drive Technical Innovation
  • Lead technical evaluations, implementation activities, and process validations for new products
  • Develop manufacturing methods, equipment specifications, and statements of work for production and development programs
  • Analyze complex materials and manufacturing challenges using engineering principles and data analytics
  • Support technology transfer, manufacturing scale-up, and process optimization activities
Lead Cross-Functional Projects
  • Serve as project manager for capital projects related to product development
  • Partner with Manufacturing, Quality, Design Engineering, and CAE teams to optimize product designs and manufacturing processes
  • Provide engineering support during production scale-up, troubleshooting, and process improvements
  • Assist laboratory personnel in developing new testing methods and validation protocols
Partner with Customers & Industry Leaders
  • Serve as the technical liaison for customers, suppliers, and external partners
  • Lead customer, supplier, and vendor interactions related to product development and validation
  • Represent MediTECH through ASTM, ORS, Biomaterials organizations, and other professional societies
  • Deliver technical presentations and publish papers that position Mitsubishi Chemical as an industry leader
Ensure Quality & Regulatory Excellence
  • Support product development activities in accordance with FDA Quality System Regulations and applicable ISO standards
  • Prepare technical reports, validation documentation, and engineering records
  • Maintain confidentiality while ensuring compliance with quality, regulatory, and customer requirements
  • Contribute to risk assessments, design controls, and technical documentation throughout the product lifecycle

What We're Looking For
  • Bachelor's degree in Engineering or a related technical discipline
  • 5+ years of experience in the orthopedic or medical device industry
  • Experience leading product development and engineering projects from concept through commercialization
  • Strong understanding of engineering principles related to product design, materials, and manufacturing processes
  • Experience reading and interpreting customer specifications and engineering drawings
  • Demonstrated project management experience with the ability to manage multiple priorities simultaneously
  • Strong analytical skills with experience using engineering and statistical analysis software, including Minitab
  • Excellent technical writing, presentation, and communication skills
  • Ability to collaborate effectively with customers, suppliers, and cross-functional teams
  • Self-motivated with strong leadership and organizational skills
  • Proficiency with Microsoft Office and collaboration tools such as Microsoft Teams

Preferred Qualifications
  • Experience with medical device design controls (21 CFR 820.30)
  • Knowledge of FDA Quality System Regulations and ISO 13485
  • Experience with ISO 10993 biocompatibility standards
  • Knowledge of ISO 14971 risk management processes
  • Experience with Design History Files (DHF) and medical device documentation
  • Experience with implantable device materials, including metals, polymers, and surface treatments
  • Experience creating FDA Master Files
  • Background in orthopedic implant materials or surgical applications

Work Arrangement & Travel
  • On-site or Hybrid opportunity
  • Hybrid schedule requires a minimum of three days per week on-site in Fort Wayne, IN
  • Less than 25% travel

Why Join Us?
  • Develop innovative materials that improve patient outcomes around the world
  • Lead high-impact R&D projects from concept through commercialization
  • Collaborate with experts in engineering, manufacturing, quality, and regulatory affairs
  • Represent Mitsubishi Chemical within leading medical and biomaterials organizations
  • Help shape the future of orthopedic implant technologies
  • Join a global organization committed to innovation, quality, and scientific excellence
  • Competitive compensation and comprehensive benefits package

If you're a technically driven engineer with a passion for medical device innovation, product development, and solving complex engineering challenges, we encourage you to apply and help shape the future of orthopedic materials and technologies.
The salary range for this position is $100,922 - $126,152 USD Annual. Factors such as scope and responsibilities of the position, candidate's work experience, education/training, job-related skills, internal peer equity, as well as market and business considerations may influence base pay offered. This salary will be subject to a geographic adjustment (according to a specific city and state), if an authorization is granted to work outside of the location listed in this posting.
All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, or other legally protected status
Mitsubishi Chemical Advanced Materials Inc. is committed to working with and providing reasonable accommodation to individuals with physical and mental disabilities. If you need special assistance or an accommodation while seeking employment, please email MCA-MBX_accomodations@m-chem.com. We will make a determination on your request for reasonable accommodation on a case-by-case basis.
The law requires Mitsubishi Chemical Advanced Materials Inc. to post a notice describing the Federal laws prohibiting job discrimination. For information regarding your legal rights and protections, please click on the following link: Know Your Rights
Mitsubishi Chemical Advanced Materials Inc. will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay. Please see the Pay Transparency Nondiscrimination Provision for more information
As a Federal Contractor, Mitsubishi Chemical Advanced Materials Inc. is required to participate in the E-Verify Program to confirm eligibility to work in the United States. For information please click on the following link: E-Verify.

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