Process Engineer

Job Description

The Sustaining Engineer supports the continued performance, quality, compliance, and lifecycle management of existing products within a regulated environment. This role ensures that products remain reliable, manufacturable, and aligned with applicable regulatory and quality standards through ongoing maintenance, engineering change evaluation, issue resolution, and verification activities. The Engineer also leads or supports validation efforts for product updates, enhancements, and line extensions, ensuring that all modifications meet design, quality, manufacturing, and customer requirements.

By collaborating closely with cross-functional teams in Engineering, Quality, Operations, Supply Chain, and Regulatory, this position plays a key role in maintaining product continuity and driving continuous improvement in both products and processes.

The Sustaining Engineer supports the continued performance, quality, compliance, and lifecycle management of existing products within a regulated environment. This role ensures that products remain reliable, manufacturable, and aligned with applicable regulatory and quality standards through ongoing maintenance, engineering change evaluation, issue resolution, and verification activities. The Engineer also leads or supports validation efforts for product updates, enhancements, and line extensions, ensuring that all modifications meet design, quality, manufacturing, and customer requirements.

By collaborating closely with cross-functional teams in Engineering, Quality, Operations, Supply Chain, and Regulatory, this position plays a key role in maintaining product continuity and driving continuous improvement in both products and processes.

• Support the continued performance, quality, and compliance of existing products throughout their lifecycle.
• Ensure products remain reliable and manufacturable by monitoring performance and addressing technical issues as they arise.
• Evaluate engineering changes to existing products and processes, ensuring alignment with design intent, quality standards, and regulatory requirements.
• Lead or support issue resolution activities, including root cause analysis and implementation of corrective and preventive actions.
• Plan, execute, and document verification activities to confirm that product changes meet defined requirements and specifications.
• Lead or support validation activities related to product updates, enhancements, and line extensions to ensure changes are robust and compliant.
• Collaborate with cross-functional teams, including Engineering, Quality, Operations, Supply Chain, and Regulatory, to implement product and process changes effectively.
• Drive continuous improvement initiatives focused on product quality, manufacturability, and process efficiency within a regulated environment.
• Support lifecycle management activities, including documentation updates, risk assessments, and change control processes.
• Contribute to maintaining alignment with Good Manufacturing Practice (GMP) and other applicable regulatory and quality standards.
• Use CAD tools to support design changes, documentation updates, and engineering evaluations for existing products.
• Apply project management and leadership skills to plan, coordinate, and deliver sustaining engineering activities on time and within scope.

• Bachelor's degree in Mechanical Engineering, Biomedical Engineering, Plastics/Polymer Engineering, or a related engineering discipline.
• 2+ years experience
• Hands-on experience in manufacturing engineering, with a focus on maintaining and improving existing products and processes.
• Proficiency in sustaining engineering activities, including change control, issue resolution, and lifecycle management.
• Experience working in compliance with Good Manufacturing Practice (GMP) standards.
• Proficiency with CAD tools to support design changes and engineering evaluations.
• Experience with validation activities for product or process changes in regulated industries.
• Strong project management and leadership skills to coordinate cross-functional sustaining initiatives.
• Ability to collaborate effectively with Engineering, Quality, Operations, Supply Chain, and Regulatory teams.

• Experience in process improvement initiatives aimed at enhancing product quality, reliability, and manufacturability.
• Familiarity with lifecycle management of products in Bio-Pharm, Medical Devices, or Life Sciences environments.
• Exposure to verification and testing methodologies for existing product changes.
• Ability to interpret and apply regulatory and quality standards to product and process changes.
• Strong analytical and problem-solving skills, including root cause analysis and corrective action implementation.
• Effective communication skills for working with cross-functional stakeholders and documenting engineering activities.

The Engineer works in a regulated manufacturing and engineering…