The Planet Group
This range is provided by The Planet Group. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.
Base pay range $75,000.00/yr - $90,000.00/yr
Direct message the job poster from The Planet Group
Validation Engineer – Medical Device Manufacturing Indianapolis, IN | Onsite
Are you passionate about building medical solutions that truly matter? At our Indianapolis facility, we design and deliver life-saving medical products, from automated drug delivery systems to complex device assemblies. We’re growing our Validation team and are looking for a Validation Engineer who thrives in a regulated environment and is eager to make an impact in healthcare innovation.
This is not just another engineering job. It’s a chance to contribute to products that end up in the hands of patients worldwide — devices like auto-injectors that provide life-saving medication in critical moments. You’ll be part of a collaborative team that values quality, documentation excellence, and data-driven decision making.
What You’ll Do
Develop and author Validation Plans (VPs) and protocols for all phases of the validation lifecycle.
Execute test protocols, analyze data using statistical tools/software (Minitab, etc.), and communicate insights.
Lead and schedule Validation Review Board (VRB) meetings, review and approve validation documentation, and allocate resources across projects.
Support process and equipment qualifications (IQ, OQ, PQ) and test method validations.
Partner with medical device customers to deliver validation processes that meet regulatory expectations.
Maintain documentation in compliance with FDA 21 CFR 820, GMP, and ISO13485 requirements.
Mentor other engineers on validation practices and contribute to continuous improvement initiatives.
What We’re Looking For
2–5 years of experience in validation, ideally in medical device manufacturing (highly regulated industries like aerospace may also be considered).
Bachelor’s degree in Mechanical, Electrical, or Biomedical Engineering (or related).
Hands-on knowledge of automated and manual assembly, molding, and packaging processes.
Strong background in process characterization, GR&R studies, and statistical data analysis.
Proven ability to balance multiple projects, prioritize effectively, and keep accurate records.
Quality-driven mindset with the ability to lead in a compliance-focused environment.
Proficiency in Microsoft Office tools (Word, Excel, PowerPoint, Project, Visio).
What Success Looks Like In the first 3 months:
You’ll establish yourself in VRB meetings, support protocol/report generation, and contribute to validation for commissioning production systems.
By 6 months:
You’ll lead VRB meetings, train peers in validation practices, and support lean manufacturing initiatives.
By 12 months:
You’ll be championing the validation program, guiding team members, and driving continuous improvement across the validation lifecycle.
Schedule & Location
Onsite role in
Indianapolis, IN (East side)
Business casual environment
If you’re looking for a role where your engineering skills directly contribute to patient well-being, while also enjoying a supportive and balanced workplace, this could be the right move for you.
Seniority level
Mid-Senior level
Employment type
Full-time
Industries
Medical Equipment Manufacturing
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Base pay range $75,000.00/yr - $90,000.00/yr
Direct message the job poster from The Planet Group
Validation Engineer – Medical Device Manufacturing Indianapolis, IN | Onsite
Are you passionate about building medical solutions that truly matter? At our Indianapolis facility, we design and deliver life-saving medical products, from automated drug delivery systems to complex device assemblies. We’re growing our Validation team and are looking for a Validation Engineer who thrives in a regulated environment and is eager to make an impact in healthcare innovation.
This is not just another engineering job. It’s a chance to contribute to products that end up in the hands of patients worldwide — devices like auto-injectors that provide life-saving medication in critical moments. You’ll be part of a collaborative team that values quality, documentation excellence, and data-driven decision making.
What You’ll Do
Develop and author Validation Plans (VPs) and protocols for all phases of the validation lifecycle.
Execute test protocols, analyze data using statistical tools/software (Minitab, etc.), and communicate insights.
Lead and schedule Validation Review Board (VRB) meetings, review and approve validation documentation, and allocate resources across projects.
Support process and equipment qualifications (IQ, OQ, PQ) and test method validations.
Partner with medical device customers to deliver validation processes that meet regulatory expectations.
Maintain documentation in compliance with FDA 21 CFR 820, GMP, and ISO13485 requirements.
Mentor other engineers on validation practices and contribute to continuous improvement initiatives.
What We’re Looking For
2–5 years of experience in validation, ideally in medical device manufacturing (highly regulated industries like aerospace may also be considered).
Bachelor’s degree in Mechanical, Electrical, or Biomedical Engineering (or related).
Hands-on knowledge of automated and manual assembly, molding, and packaging processes.
Strong background in process characterization, GR&R studies, and statistical data analysis.
Proven ability to balance multiple projects, prioritize effectively, and keep accurate records.
Quality-driven mindset with the ability to lead in a compliance-focused environment.
Proficiency in Microsoft Office tools (Word, Excel, PowerPoint, Project, Visio).
What Success Looks Like In the first 3 months:
You’ll establish yourself in VRB meetings, support protocol/report generation, and contribute to validation for commissioning production systems.
By 6 months:
You’ll lead VRB meetings, train peers in validation practices, and support lean manufacturing initiatives.
By 12 months:
You’ll be championing the validation program, guiding team members, and driving continuous improvement across the validation lifecycle.
Schedule & Location
Onsite role in
Indianapolis, IN (East side)
Business casual environment
If you’re looking for a role where your engineering skills directly contribute to patient well-being, while also enjoying a supportive and balanced workplace, this could be the right move for you.
Seniority level
Mid-Senior level
Employment type
Full-time
Industries
Medical Equipment Manufacturing
#J-18808-Ljbffr