Process Engineer
Job in
Huntersville, Mecklenburg County, North Carolina, 28070, USA
Listed on 2026-07-01
Listing for:
Actalent
Full Time
position Listed on 2026-07-01
Job specializations:
-
Engineering
Manufacturing Engineer, Process Engineer, Quality Engineering, Biomedical Engineer
Job Description & How to Apply Below
Job Title:
Process Engineer- MEDICAL DEVICE EXPERIENCE REQUIRED- RELOCATION OFFERED
Job Description
This Process Engineer role leads the development, sustainment, and validation of manufacturing processes and equipment for medical device products. The position focuses on defining process flows, developing fixtures and tooling, and generating engineering and production documentation for both internal and supplier-based processes. The engineer supports cross-functional projects for existing and new products, recommending specification changes based on manufacturing input, and applies a high degree of creativity and judgment to plan and accomplish complex goals in a regulated environment.
Responsibilities
+ Lead the development, sustainment, and validation of manufacturing processes and equipment used in the production of medical device products.
+ Determine and document process flows for both internal and supplier-based manufacturing processes.
+ Design, develop, and implement fixtures and tooling to support efficient and robust manufacturing operations.
+ Generate and maintain engineering and production documentation, including work instructions and process documentation, in accordance with regulatory and internal requirements.
+ Work closely with production facilities and vendors to develop, evaluate, document, implement, and improve manufacturing processes throughout the product life cycle.
+ Implement and refine process control techniques, related fixtures, and tooling to ensure consistent product quality and process capability.
+ Train personnel on new or updated processes and equipment as required.
+ Estimate staffing requirements, production times, and relative costs to provide data that supports production planning and decision-making.
+ Develop and maintain plans and timelines for project tasks throughout the process development cycle, taking into account resource constraints and project priorities.
+ Act as a technical liaison between cross-functional teams and production facilities, including vendors, for both new and existing products and processes.
+ Lead process-related risk management activities, including process risk assessments, and support application and design risk management related to products.
+ Plan, create, and execute process validations (IQ/OQ/PQ) in accordance with FDA and harmonized standards, including preparation of technical protocols, reports, and feasibility studies.
+ Plan, lead, and facilitate production transfers, including production floor layout and facility planning activities such as equipment spacing and utilities.
+ Ensure compliance with all standard operating procedures and regulatory requirements related to the development and manufacture of medical devices, including FDA 21 CFR Part 820 and applicable harmonized standards.
+ Develop appropriate preventive maintenance plans and coordinate calibration and preventive maintenance activities with Quality and Production departments.
+ Collaborate with quality and development engineers to define critical aspects for inspection procedures, gauges, and measurement methods for new and existing products.
+ Create and maintain accurate documentation of process specifications, work instructions, tooling drawings, design concepts, shop orders, and related documentation in alignment with R&D and quality assurance requirements.
+ Provide engineering support to production facilities and vendors to troubleshoot and resolve technical problems in a timely manner.
+ Optimize products, processes, tooling, and equipment to meet customer needs, technical design goals, regulatory and quality requirements, and cost and efficiency targets using Lean and Six Sigma techniques and tools.
+ Attend and actively contribute to team meetings associated with assigned projects, providing technical input and progress updates.
+ Evaluate new processing technologies and recommend their adoption where they can improve quality, efficiency, or cost-effectiveness.
Essential Skills
+ More than 10 years of relevant experience in the medical device and/or pharmaceutical field, with a demonstrated understanding of industry requirements and regulations.
+ Proven experience in developing, sustaining, and validating manufacturing processes and equipment for regulated products, preferably medical devices.
+ Strong knowledge of FDA 21 CFR Part 820 and harmonized standards relevant to medical device manufacturing.
+ Hands-on experience with process mapping, process development, process characterization, qualification/validation, and capability analysis (preferred but strongly beneficial).
+ Demonstrated ability to plan, write, and execute process validations (IQ/OQ/PQ), including authoring protocols and reports.
+
Experience with process improvements and process layouts in a manufacturing environment.
+ Proficiency in Microsoft Office applications, with the ability to create and manage technical documentation, reports, and project plans.
Additional
Skills & Qualifications
+ Experience in the…
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