Process Engineer II
Apex Systems
- Process Engineer IIApply**Job#: 3044741****Job Description:**Process Engineer – Medical Device ManufacturingPosition SummaryWe are seeking a Process Engineer to support new product development, manufacturing process implementation, equipment validation, and continuous improvement initiatives within a regulated medical device manufacturing environment. This individual will be responsible for assessing and improving manufacturing processes, driving validation activities, managing project timelines, coordinating suppliers and contractors, and ensuring compliance with FDA regulations, GMP requirements, and internal quality standards.The ideal candidate will have experience with equipment and process validation (IQ/OQ/PQ), statistical analysis, process qualification, technical documentation, and cross-functional project management.Key ResponsibilitiesProcess Engineering & Continuous Improvement* Analyze and assess supplier and internal manufacturing processes to determine process capability and identify improvement opportunities.* Design, develop, and optimize manufacturing processes and equipment to improve productivity, quality, and operational efficiency.* Conduct feasibility studies, process evaluations, and statistical analyses to support implementation of new manufacturing technologies and processes.* Develop process control strategies using data analysis, validation studies, and Statistical Process Control (SPC) methodologies.* Support supplier assessment, qualification, and selection activities.Validation & Qualification Activities* Lead and support Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) activities for manufacturing equipment and processes.* Develop and execute validation protocols, test plans, and qualification documentation.* Ensure validation activities comply with FDA regulations, GMP requirements, and company quality standards.* Perform: + Preventive Maintenance Reviews + Environmental Health & Safety Assessments + Utility Verifications (Electrical, Pneumatic, Hydraulic Systems) + Software Verifications + Functional Testing + Calibration Verification Activities + Equipment Documentation Reviews + Training Program Development and Verification* Ensure proper material, equipment, and data traceability throughout validation activities.* Support protocol execution, discrepancy resolution, and final validation reporting.Documentation & Compliance* Author, review, and update: + Validation Protocols + Standard Operating Procedures (SOPs) + Test Protocols and Procedures + Engineering Drawings + Equipment Specifications + Training Materials + Raw Material Specifications + Change Control Documentation Packages* Maintain accurate documentation within Quality Management Systems (QMS).* Ensure compliance with FDA, GMP, OSHA, and internal quality requirements.Project Management & Supplier Coordination* Manage project timelines and site deliverables for equipment and process implementation projects.* Coordinate activities with vendors, suppliers, contractors, quality teams, manufacturing personnel, and engineering stakeholders.* Support equipment commissioning, startup, and process transfer activities.* Present project updates, validation results, risk assessments, and cost-justification analyses to leadership.* Prioritize multiple projects and rapidly address unplanned manufacturing issues and troubleshooting needs.Operations Support* Provide technical support for manufacturing operations and automated production equipment.* Assist with troubleshooting, corrective actions, and process optimization initiatives.* Maintain a clean and safe work environment while demonstrating a strong sense of urgency, ownership, and accountability.* Communicate project status, risks, and issues effectively to leadership and stakeholders.Required QualificationsEducation* Bachelor's Degree in Mechanical Engineering, Electrical Engineering, Manufacturing Engineering, or related engineering discipline.Experience* Minimum 2 years of engineering experience in a manufacturing environment.* Experience within medical device manufacturing strongly preferred.* Working knowledge of: + FDA regulations for medical device manufacturing + Good Manufacturing Practices (GMP) + Process Validation Methodologies (IQ/OQ/PQ) + Equipment Validation and Qualification + Change Control Documentation + Manufacturing Equipment and Automated Systems* Experience developing and executing validation protocols and technical documentation.* Project management experience supporting cross-functional initiatives.Preferred Qualifications* Experience within pharmaceutical or highly regulated manufacturing environments.* Experience with printing systems and labeling management systems.* Knowledge of AutoCAD and engineering design tools.* Experience supporting equipment commissioning and startup activities.* Familiarity with supplier qualification and vendor management processes.Technical Skills* Microsoft Office Suite (Excel, Word, PowerPoint, Project)* Quality Management Systems (QMS)* Minitab or equivalent statistical analysis software* Agile methodologies* Statistical Process Control (SPC)* Data Analysis and Process Capability Studies* Technical Documentation DevelopmentKey Competencies* Strong technical writing and documentation skills* Excellent verbal and written communication skills* Strong organizational and project management abilities* Ability to manage multiple priorities in a fast-paced environment* Analytical problem-solving and troubleshooting skills* Self-motivated and results-driven* Strong interpersonal and vendor management skills* Ability to work independently and collaboratively across multiple functions* High level of integrity, accountability, and attention to detailIdeal Candidate ProfileThe ideal candidate has hands-on experience with medical device process validations (IQ/OQ/PQ), equipment qualification, statistical analysis, and technical documentation. They are comfortable managing suppliers, driving projects from conception through implementation, and ensuring all validation requirements are executed in accordance with regulatory and quality standards.EEO EmployerApex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at View email address on click.appcast.io or View phone number on click.appcast.io. *Everforth Apex is a world-class IT services company that serves thousands of clients across the globe. When you join Everforth Apex, you become part of a team that values innovation, collaboration, and continuous learning. We offer quality career resources, training, certifications, development opportunities, and a comprehensive benefits package. Our commitment to excellence is reflected in many awards, including ClearlyRateds Best of Staffing in Talent Satisfaction in the United States and Great Place to Work in the United Kingdom and Mexico.**Everforth Apex uses a virtual recruiter as part of the application process. Click here for more details. By applying for this job, you agree to receive calls, AI-generated calls, text messages, or emails from Everforth Apex and its affiliates, and contracted partners. Frequency varies for text messages. Message and data rates may apply. Carriers are not liable for delayed or undelivered messages. You can reply STOP to cancel and HELP for help. You can access our privacy policy at Apex Benefits Overview: Everforth Apex offers a range of supplemental benefits, including medical, dental, vision, life, disability, and other insurance plans that offer an optional layer of financial protection. We offer an ESPP (employee stock purchase program) and a 401K program which allows you to contribute typically within 30 days of starting, with a company match after 12 months of tenure. Everforth Apex also offers a HSA (Health Savings Account on the HDHP plan), a SupportLinc Employee Assistance Program (EAP) with up to 8 free counseling sessions, a corporate discount savings program and other discounts. In terms of professional development, Everforth Apex hosts an on-demand training program, provides access to certification prep and a library of technical and leadership courses/books/seminars once you have 6+ months of tenure, and certification discounts and other perks to associations that include CompTIA and IIBA. Everforth Apex has a dedicated customer service team for our Consultants that can address questions around benefits and other resources, as well as a certified Career Coach. You can access a full list of our benefits, programs, support teams and resources within our ‘Welcome Packet’ as well, which an Everforth Apex team member can provide.**Everforth Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Everforth Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law.**If you require an accommodation under the Americans with Disabilities Act to participate in an interview with a virtual recruiter or to use our website for a search or application, please contact our Benefits Department at View email address on click.appcast.io or View phone number on click.appcast.io. Please note that this contact information is strictly to be used for medical ADA accommodations and that no other inquiries will be answered.**UnitedHealthcare creates and publishes the Transparency in Coverage Machine-Readable Files on behalf of Everforth Apex Systems.***Employee Type:** Contract**Location:** Riverview, FL, US**Job Type:** Engineering and Technicians**Date Posted:** August 3, 2026**Pay Range:** $31 - $35 per hour
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