Job Description

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.

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