Mechanical Product Validation Engineer

Job Title: Mechanical Product Validation Engineer

Location: Cincinnati, Ohio

Work Arrangement: Onsite

Employment Type: Contract

Duration: 11 months

Pay Range: $26.37/hr. To $29.54/hr. On W2 | $34.29/hr. to $38.40/hr. on C2C

Domain: Healthcare | Medical Devices

Application Deadline: June 10, 2026

SKILLS REQUIRED

Primary (Must-Have):

• 8 years of experience in Mechanical Engineering within the medical device domain

• Strong expertise in Cleaning & Sterilization (C&S) Validation and reprocessing validation for reusable medical devices

• Proven experience in Test Method Development and product quality assurance

• Hands-on proficiency with Design Failure Mode and Effects Analysis (DFMEA) and Process Failure Mode and Effects Analysis (PFMEA)

• Strong background in Root Cause Analysis (RCA) and Gage Repeatability & Reproducibility (GR&R) studies

• Deep understanding of validation documentation and applied statistical analysis

Secondary (Good to Have):

• Experience managing workflows with external suppliers, test laboratories, and sterilization vendors

• Familiarity with hazard analyses and broader risk management frameworks

• Strong cross-functional stakeholder management and technical presentation skills

POSITION OVERVIEW

We are seeking an experienced Mechanical Product Validation Engineer for an onsite engagement in Cincinnati, Ohio. The ideal candidate will possess deep, hands-on expertise in cleaning, sterilization, and reprocessing validation specifically for reusable medical devices. In this role, you will be responsible for developing robust test methods, executing feasibility studies, conducting root cause analysis, and supporting risk management through cross-functional collaboration to ensure compliance with strict product quality standards.

ROLES & RESPONSIBILITIES

• Develop soiling, cleaning, and extraction processes for reusable scopes, instruments, and accessories (I&A), incorporating real-world use conditions and cleanability considerations.

• Plan, execute, and analyze Cleaning and Sterilization (C&S) feasibility studies, cleanability assessments, and sterilization validations.

• Create and qualify test methods, perform Gage Repeatability & Reproducibility (GR&R) studies, and document results in engineering protocols, reports, and validation documentation using statistical analysis.

• Conduct root cause analysis for C&S process issues and evaluation findings, communicating data-driven solutions and recommendations to R&D and cross-functional stakeholders.

• Support the development and completion of risk management documentation (including DFMEAs, PFMEAs, and hazard analyses) by providing hands-on laboratory expertise and technical input.

• Support Design Reviews and Phase Exit Reviews by preparing required documentation, developing presentation materials, and presenting technical content related to reprocessing.

• Partner with internal teams and external supplier resources (e.g., independent test laboratories, sterilization vendors) to ensure timely completion of product development and launch deliverables.

BENEFITS

Medical | Dental | Vision | 401(k)

EEOC Compliance

We are an equal opportunity employer, and all qualified applicants will receive consideration for employment.

DISCLAIMER

AI Usage Policy: Pacer Group uses AI to assist in screening applications. Final hiring decisions are made by human recruiters based on qualifications and experience.