Senior Process Engineer

The Process Engineer develops, improves, and supports manufacturing processes used to produce medical devices. This role collaborates closely with production, quality, R&D, and external suppliers to ensure products are manufactured efficiently, meet stringent quality standards, and comply with FDA and ISO regulations. The position offers the opportunity to lead process initiatives, support new product introductions, and drive continuous improvement in a highly collaborative environment.Job Title: Process EngineerResponsibilitiesDevelop, implement, and improve manufacturing processes, equipment, tooling, and detailed work instructions for medical device production.Support new product introductions by defining robust manufacturing processes, qualifying equipment, and ensuring smooth transition into production.Lead process validations, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ), and maintain all required validation documentation.Create and maintain comprehensive process documentation, including work instructions, process flow diagrams, and risk assessments such as Failure Modes and Effects Analyses (FMEAs).Work with suppliers and internal manufacturing teams to troubleshoot production issues, perform root cause analysis, and implement effective corrective and preventive actions.Support production transfers, including planning and executing facility layouts, equipment moves, and new equipment installations.Partner with Quality, Operations, and Engineering teams to ensure all processes comply with FDA and ISO standards and internal quality system requirements.Develop preventive maintenance plans for critical equipment and support calibration activities to maintain process capability and compliance.Drive continuous improvement initiatives focused on safety, quality, efficiency, and cost reduction using Lean and Six Sigma methodologies.Evaluate, recommend, and implement new manufacturing technologies and process improvements to enhance productivity and product quality.Manage project timelines, prioritize tasks, and coordinate activities across cross‑functional teams to ensure successful and timely project completion.Contribute to process mapping, development, characterization, qualification, validation, and capability analysis to ensure stable and capable processes.Collaborate with packaging engineering to develop and optimize packaging processes for medical devices, where applicable.Essential SkillsMore than 10 years of relevant experience in the medical device and/or pharmaceutical field, with a strong understanding of industry requirements and regulations.Proven experience developing, improving, and supporting manufacturing processes for regulated products.Demonstrated knowledge of FDA and ISO regulations as they apply to medical device manufacturing.Hands‑on experience leading process validations, including IQ, OQ, and PQ, and managing associated documentation.Proficiency in process mapping, process development, process characterization, qualification and validation, and capability analysis.Strong experience in process improvements and process layouts within a manufacturing environment.Experience working with cross‑functional teams including Production, Quality, R&D, and suppliers.Computer literacy with experience using Microsoft Office applications.Ability to manage multiple projects and timelines while maintaining attention to detail and compliance.Strong problem‑solving skills with the ability to troubleshoot complex production issues and implement effective solutions.Excellent written and verbal communication skills for creating clear documentation and collaborating across teams.Additional Skills & QualificationsB.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; SolidWorks 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 EnvironmentThe 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 & LocationPermanent position based out of Huntersville, NC.Pay And BenefitsThe pay range for this position is $45.00 - $60.00/hr.Medical, dental & visionCritical Illness, Accident, and Hospital401(k) Retirement Plan – Pre‑tax and Roth post‑tax contributions availableLife Insurance (Voluntary Life & AD&D for the employee and dependents)Short and long‑term disabilityHealth Spending Account (HSA)Transportation benefitsEmployee Assistance ProgramTime Off/Leave (PTO, Vacation or Sick Leave)Workplace TypeThis is a hybrid position in Huntersville, NC.Application DeadlineThis position is anticipated to close on Jul 24, 2026.Equal Opportunity and AccessibilityThe company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.#J-18808-Ljbffr