Senior Manufacturing Process Engineer (Onsite)

What You'll Do

Process Optimization

• Develop, optimize, and sustain manufacturing processes to improve quality, yield, throughput, and reliability.
• Conduct process capability studies, SPC analysis, MSA/GR&R, DOE, and root cause investigations.
• Reduce scrap, rework, downtime, and process variation.
• Establish process controls, reaction plans, control plans, and standard work.
• Support production troubleshooting and technical issue resolution.

Project Management

• Lead manufacturing engineering projects from concept through implementation.
• Manage engineering trials, equipment upgrades, and process changes.
• Coordinate validation activities, project timelines, deliverables, risks, and stakeholder communication.
• Support NPI, facility readiness, and automation deployment initiatives.
• Drive closure of engineering action items, CAPAs, and continuous improvement projects.

Regulatory Compliance and Documentation

• Author and execute Process Validation Plans, IQ/OQ/PQ protocols, and validation reports.
• Maintain PFMEAs, control plans, process flow diagrams, and Requirements Traceability Matrices.
• Support Process Change Assessments, risk assessments, and revalidation activities.
• Ensure manufacturing processes comply with QMS, regulatory, and audit requirements.
• Maintain accurate, audit-ready technical documentation and engineering records.

Collaboration and Cross-Functional Support

• Partner with Production, Quality, Product Development, Test Engineering, Automation, Maintenance, Planning, and Facilities teams.
• Represent Manufacturing Engineering during design reviews, project reviews, validation reviews, and audits.
• Provide technical guidance and training to operators, technicians, and engineering teams.
• Support issue resolution across product lifecycle stages from development through production.
• Facilitate effective communication between manufacturing operations and development teams.

Innovation and Continuous Improvement

• Develop and maintain manufacturing dashboards, analytics, and process-monitoring tools.
• Leverage manufacturing data to identify trends, opportunities, and performance gaps.
• Drive automation, digitization, and manufacturing systems improvements (MES, eDHR, Power BI, Tableau, etc.).
• Evaluate and implement new technologies, tools, and best practices.
• Lead continuous improvement initiatives focused on safety, quality, productivity, and cost reduction.

What You Bring

Minimum Qualifications

• Senior Process Engineer: Minimum 5 years of manufacturing/process engineering experience.
• Bachelor's degree in Industrial Engineering, Mechanical Engineering, Manufacturing Systems Engineering, Biomedical Engineering, or a related engineering discipline.
• Experience supporting production lines in a 24/7 manufacturing environment.
• Hands-on experience with automated manufacturing equipment and systems.
• Proven track record of leading and supporting engineering projects in highly collaborative, cross-functional environments.
• Strong knowledge of quality systems, including ISO 13485, FDA regulations, and manufacturing validation practices.
• Experience with process validation, including IQ/OQ/PQ, risk assessments, and change management.
• Knowledge of manufacturing processes & equipment for high volume production of discrete products.
• Excellent communication and documentation skills, including technical reports.
• Proficient with CAD software (e.g., SolidWorks) and data analysis/statistical tools (e.g., Minitab, JMP).
• Ability and willingness to work a flexible schedule to support project execution, validation activities, and critical production issues.
• Perform other duties as assigned to support business, operational, and project objectives.

Preferred Qualifications

• Master's degree in an engineering-related field.
• Experience in medical device manufacturing and regulated environments.
• Knowledge of manufacturing systems, process monitoring systems, and statistical process control.
• Six Sigma Green Belt or higher certification.
• Experience with manufacturing data analytics platforms such as Power BI, Tableau, MES, or eDHR systems.
• Experience supporting automation, equipment commissioning, line transfers, or new product introduction (NPI).

What Sets You Apart

Core Competencies

• Strong analytical problem-solving and decision-making skills.
• Excellent communication and interpersonal abilities.
• Detail-oriented with a strong commitment to quality, compliance, and documentation.
• Ability to manage multiple priorities in a fast-paced manufacturing environment.
• Strong project management and organizational skills.
• Team player with a proactive approach to innovation and continuous improvement.
• Ability to influence and collaborate effectively across Operations, Quality, Product Development, Planning, Automation, and Facilities teams.