Senior Process Engineer

About the role

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.

Responsibilities

• Develop, 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.
• 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.

Requirements

• More 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.
• Able 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.

Essential Skills

• 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; SolidWorks software experience preferred.
• Packaging engineering experience is highly preferred, particularly in medical device applications.
• Experience supporting production transfers, facility layouts, and equipment installations.
• Able 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.