Equipment Process Engineer

Job Description

An employer is seeking Senior Equipment Process Engineer to support New Product Development (NPD) and manufacturing scale-up of medical devices in a regulated environment. This role will be long term and located in the Blue Ash, OH area. The equipment process engineer will be responsible for the development, qualification, and optimization of custom manufacturing equipment and processes that meet stringent quality, reliability, and regulatory requirements. The ideal candidate brings deep expertise in equipment-centric process development, supplier collaboration, and material-sensitive manufacturing processes, with a strong understanding of FDA and ISO expectations.

The core responsibilities will include:

-Develop and refine New Product Development (NPD) processes in compliance with FDA, ISO 13485, and internal quality system requirements.

-Partner with equipment suppliers to design, build, and qualify new manufacturing equipment and process solutions.

-Lead process characterization activities to identify and optimize Critical Process Parameters (CPPs) and Critical Quality Attributes (CQAs).

-Design and execute Design of Experiments (DOE); perform statistical analysis and establish process capability (Cp/Cpk, Pp/Ppk).

-Define and implement process control limits, control plans, and monitoring strategies to ensure sustained process performance.

-Plan and execute Measurement System Analysis (MSA) and Gage R&R studies to validate measurement methods.

-Provide hands-on technical support during equipment development, FAT/SAT, installation, qualification, validation, and production ramp-up.

-Qualify and validate PLC-controlled software systems; troubleshoot issues, document changes, and support software fixes.

-Collaborate cross-functionally with R&D, Manufacturing, Quality, and Supply Chain to drive compliant, scalable solutions to market.

We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to [email protected] learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy:

Skills and Requirements

Bachelor's degree in Engineering (Mechanical, Electrical, Manufacturing, Chemical, or related).

Experience in medical device, pharmaceutical, or other highly regulated manufacturing environments.

Strong knowledge of GMPs, validation methodologies, and equipment lifecycle management.

3+ years developing custom sterile barrier packaging and boxing equipment and processes (foil-based, bioabsorbable, and moisture-sensitive materials)

Hands-on experience with vacuum drying equipment and associated process development and validation.

Proven ability to manage external equipment suppliers through design, build, and qualification phases in a regulated environment.

Ability to travel domestically once a month to supplier sites medical device certifications