Process Engineer

Job Title:

Junior Process Engineer

Job Description

The Junior Process Engineer supports the development, improvement, and maintenance of manufacturing processes used to produce medical devices. Working closely with Production, Quality, R&D, and suppliers, this role helps ensure products are manufactured efficiently, meet quality standards, and comply with FDA and ISO requirements. This is an excellent opportunity for an early-career engineer to gain hands-on experience in process development, validation, troubleshooting, and continuous improvement within a regulated manufacturing environment.

Responsibilities

- Assist with the development, implementation, and improvement of manufacturing processes, equipment, tooling, and work instructions.

- Support new product introductions through process development, equipment qualification, and production readiness activities.

- Participate in process validation activities (IQ, OQ, PQ) and maintain validation documentation.

- Create and maintain process documentation, including work instructions, process flows, and risk assessments.

- Support manufacturing troubleshooting efforts, root cause investigations, and corrective actions.

- Collaborate with Production, Quality, Engineering, and suppliers to improve process performance and product quality.

- Assist with equipment installations, production transfers, facility layout changes, and process improvement projects.

- Help ensure compliance with FDA regulations, ISO standards, and internal quality system requirements.

- Collect and analyze process data to identify opportunities for efficiency, quality, and cost improvements.

- Participate in Lean and continuous improvement initiatives across the manufacturing operation.

Essential Skills

- Bachelor's degree in Mechanical Engineering, Manufacturing Engineering, Industrial Engineering, Packaging Science, or a related engineering discipline.

- 0-3 years of engineering experience in a manufacturing environment; internships and co-op experience will be considered.

- Basic understanding of manufacturing processes, process improvement, and engineering principles.

- Exposure to regulated industries such as medical devices, pharmaceuticals, or other manufacturing environments preferred.

- Familiarity with FDA regulations, ISO standards, process validation, or quality systems is a plus.

- Experience with Microsoft Office applications; ERP systems (D365, SAP, etc.) preferred.

- Exposure to CAD software such as Solid Works is preferred.

- Strong analytical, problem-solving, organizational, and communication skills.

- Ability to work collaboratively in a fast-paced, team-oriented environment while managing multiple priorities.

Additional

Skills & Qualifications

+ B.S. in Mechanical Engineering, Manufacturing Engineering, Industrial Engineering, Packaging Science, or another appropriate engineering discipline.

+ Experience in the medical device or pharmaceutical industry with direct exposure to regulated manufacturing environments.

+

Experience with Lean and Six Sigma methodologies for continuous improvement initiatives.

+ D365 or similar ERP system experience preferred.

+ Experience in 3D modeling and drafting;
Solid Works software experience preferred.

+ Packaging engineering experience is highly preferred, particularly in medical device applications.

+ Experience supporting production transfers, facility layouts, and equipment installations.

+ Ability to work effectively in a collaborative, high-urgency environment and align with a culture that values teamwork, accountability, and continuous improvement.

+ Strong organizational skills with the ability to maintain comprehensive and compliant documentation.

Work Environment

The role is based in a clean, brand-new manufacturing facility with a strong focus on assembly operations for medical devices. Team members work with a clear sense of urgency to meet quality and delivery expectations while maintaining compliance with FDA and ISO standards. The environment is highly collaborative, with close interaction between Production, Quality, R&D, and Engineering teams. Modern tools and systems, including Microsoft Office and D365 (where used), support daily activities.

The culture emphasizes continuous improvement, safety, and professional growth, offering opportunities to contribute meaningfully to process excellence and to develop within a supportive, team-oriented setting.

Job Type & Location

This is a Contract to Hire position based out of Huntersville, NC.

Pay and Benefits

The pay range for this position is $45.00 - $60.00/hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:  - Medical, dental & vision
- Critical Illness, Accident, and Hospital  - 401(k) Retirement Plan
- Pre-tax and Roth post-tax contributions available
- Life…