Manufacturing Engineer / Process Engineer / Medical Devices

Overview:

• The Manufacturing Engineer is responsible for supporting the transfer of manufacturing processes from an external vendor to in-house production. This role will coordinate and execute key transfer activities to ensure a smooth, compliant, and efficient transition of products, processes, equipment, and documentation into the internal manufacturing environment. The engineer will work cross-functionally with Operations, Quality, Supply Chain, Product Development, Regulatory, and external partners to establish robust manufacturing processes that meet safety, quality, delivery, and cost objectives.

Key Responsibilities

• Lead and support manufacturing transfer activities from outside vendors to internal manufacturing sites.
• Develop and execute transfer plans, timelines, and readiness activities to support successful production launch.
• Evaluate existing supplier manufacturing processes, tooling, fixtures, equipment, process controls, and documentation for transfer suitability.
• Partner with cross-functional teams to define manufacturing requirements, capacity needs, equipment needs, and production flow for in-house manufacturing.
• Create, revise, and maintain manufacturing documentation including:
• work instructions
• routers
• process flows
• PFMEAs
• control plans
• equipment qualifications
• validation protocols and reports
• Support process development, process characterization, and process validation activities including equipment IQ and Process OQ, and PQ, as applicable.
• Coordinate equipment installation, qualification, and implementation for transferred processes.
• Identify process risks and implement mitigation plans to ensure quality and continuity of supply.
• Troubleshoot manufacturing issues during transfer, pilot builds, and production ramp-up.
• Analyze manufacturing performance data and drive improvements in yield, cycle time, throughput, scrap reduction, and overall process capability.
• Ensure transferred processes comply with internal quality system requirements and applicable regulatory requirements.
• Collaborate with supplier quality and sourcing teams to support knowledge transfer, documentation handoff, and transition planning.
• Support training of production personnel and ensure manufacturing processes are released in a controlled and sustainable manner.
• Drive continuous improvement initiatives using Lean, Six Sigma, and root cause analysis methodologies.
• Support change control activities related to process transfer, equipment implementation, and documentation updates.

Required Qualifications

• Bachelor’s degree in Engineering discipline
• Minimum of 3 to 5 years of engineering experience in manufacturing, process engineering, industrialization, or operations support.
• Experience supporting manufacturing transfer, process transfer, new product introduction, or supplier-to-site transfer activities.
• Knowledge of process validation, equipment qualification, and manufacturing documentation requirements.
• Experience working in a regulated industry such as medical device, pharmaceutical, aerospace, or similar.
• Strong problem-solving, project management, and cross-functional collaboration skills.
• Strong written and verbal communication skills.
• Ability to manage multiple priorities in a fast-paced manufacturing environment.

Preferred Qualifications

• Experience in medical device manufacturing.
• Familiarity with GMP, GDP, FDA, ISO 13485, and applicable regulatory requirements.
• Experience with risk management tools such as PFMEA and control plans.
• Experience with Lean manufacturing and continuous improvement methodologies.
• Knowledge of statistical methods, process capability, and data analysis tools.
• Experience with ERP/MRP systems and manufacturing execution systems.
• Six Sigma certification or formal continuous improvement training.
• Experience supporting pilot builds, line set-up, and production ramp.

Key Competencies

• Technical leadership
• Manufacturing process development
• Project execution
• Cross-functional collaboration
• Risk identification and mitigation
• Problem solving and root cause analysis
• Documentation and change management
• Continuous improvement mindset

Years’ Experience Required: 3-5 years of relevant experience providing manufacturing transfer support

Does this position require the candidate to be onsite or remote, if hybrid what does the onsite vs remote schedule look like? onsite

What is your timeline for scheduling interviews? ASAP

What product line will this person support? This position is not product specific. The project covers multiple product lines.