Advanced Process Engineer

JOB DESCRIPTION:

The Advanced Process Engineer - Automation & Manufacturing Systems is the technical lead for manufacturing process development and automation within Third-Party Manufacturer (TPM) Operations. This role is responsible for developing, integrating, validating, and sustaining automated manufacturing equipment and processes as products transition from R&D into commercial production.

The ideal candidate brings deep expertise in automation, manufacturing systems, process validation, and continuous improvement. This individual will partner across Engineering, Operations, Quality, Supply Chain, and external manufacturing partners to deliver scalable, compliant, and efficient manufacturing solutions.

Key Responsibilities

Automation & Equipment Engineering

• Lead the design, development, and implementation of automated manufacturing systems, including robotics, machine vision, and integrated production equipment.
• Develop User Requirement Specifications (URS), equipment specifications, and acceptance criteria.
• Manage vendor selection, equipment development, Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), installation, and commissioning activities.
• Drive improvements in equipment performance, reliability, uptime, and overall manufacturing efficiency using data-driven methodologies.

Process Development & Manufacturing Transfer

• Lead process development and scale-up activities from R&D through commercial production.
• Design robust, repeatable manufacturing processes with a focus on automation and scalability.
• Develop and maintain manufacturing documentation, including SOPs, work instructions, PFMEAs, control plans, validation protocols, and DOE reports.
• Establish validated process parameters and operating ranges using statistical analysis.
• Evaluate manufacturing line layouts, capacity, and cycle times to optimize throughput and efficiency.
• Drive continuous improvement initiatives focused on yield enhancement, process capability, and cost reduction.

Validation & Regulatory Compliance

• Lead IQ, OQ, PQ, and TMV activities for equipment and manufacturing processes.
• Ensure compliance with ISO 13485, 21 CFR Part 820, and other applicable regulatory standards.
• Conduct risk assessments using PFMEA and support ISO 14971 risk management activities.
• Manage change control activities for equipment, processes, and validated systems.

Project Leadership

• Develop and execute project plans, timelines, and technical deliverables for automation and process engineering programs.
• Monitor project milestones, identify risks, and communicate progress to stakeholders.
• Collaborate with cross-functional teams and external manufacturing partners to achieve project objectives.

Manufacturing Performance & Continuous Improvement

• Monitor key manufacturing metrics, including first-pass yield, cycle time, equipment uptime, and defect rates.
• Implement process monitoring and data collection strategies to support operational excellence.
• Troubleshoot process and equipment issues using structured problem-solving methodologies.
• Support ongoing manufacturing operations through process optimization and technical leadership.

Qualifications

Required

• Bachelor's degree in Engineering or a related technical discipline.
• 10+ years of experience in process engineering, manufacturing engineering, or automation within a regulated industry.
• Hands-on experience with automated equipment design, integration, commissioning, and validation.
• Demonstrated success implementing automation solutions that improve efficiency, throughput, and product quality.
• Strong experience with process validation methodologies, including IQ/OQ/PQ.
• Proficiency in statistical analysis and process optimization techniques.
• Experience with programming or scripting tools such as Python, SQL, or similar technologies for process automation, data analysis, and reporting.

Preferred

• Experience supporting medical device manufacturing environments.
• Knowledge of Lean Manufacturing and Six Sigma methodologies.
• Experience working with third-party manufacturing partners and technology transfers.
• Experience integrating manufacturing systems and workflows, including MES, QMS, ERP platforms, APIs, and database connectivity.

Core Competencies

• Automation Expertise: Strong knowledge of automation systems, robotics, vision systems, and manufacturing equipment integration.
• Technical Leadership: Ability to lead complex engineering initiatives and drive successful execution.
• Quality & Compliance: Understanding of regulatory requirements, validation, and risk management principles.
• Data-Driven Problem Solving: Ability to leverage analytics and statistical methods to optimize manufacturing performance.
• Cross-Functional Collaboration: Effective communicator and partner across technical and operational teams.
• Continuous Improvement Mindset: Focused on operational excellence, scalability, and sustainable process improvement.

The base pay for this position is

In specific locations, the pay range may vary from the range posted.

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