Senior Manufacturing Engineer

Title: Senior Manufacturing Engineer (Medical Devices)

Location: North of Puerto Rico (Open to Puerto Rico Residents)

Work Schedule: Onsite

Contract Duration: 6 to 12 Months

Position Overview

Our client is seeking an experienced Senior Manufacturing Engineer to lead manufacturing engineering initiatives within a regulated medical device manufacturing environment. This role is ideal for candidates with a Bachelor's degree in Engineering and 5 to 7+ years of experience in Manufacturing Engineering, Process Engineering, Validation Engineering, or Quality Engineering supporting FDA-regulated operations.

The selected candidate will provide technical leadership for manufacturing operations, process validation, process optimization, equipment qualification, documentation, and continuous improvement initiatives while collaborating with cross-functional teams throughout the product lifecycle.

Minimum Qualifications

• Bachelor's degree in Mechanical, Electrical, Industrial, Manufacturing, Biomedical Engineering, or a related Engineering discipline.
• 5 to 7+ years of experience in Manufacturing Engineering, Process Engineering, Validation Engineering, or Quality Engineering within an FDA-regulated manufacturing environment.
• Strong knowledge of 21 CFR Part 820, GMP, ISO 13485, and documentation practices required in regulated manufacturing environments.
• Experience applying electrical and mechanical engineering principles to automated or semi-automated manufacturing systems.
• Hands-on experience with automation and controls, tooling, fixtures, test method development, equipment qualification, and manufacturing process validation.
• Working knowledge of Design of Experiments (DOE), FMEA/PFMEA, CAPA, Root Cause Analysis, Statistical Process Control (SPC), Measurement System Analysis (MSA), and process capability tools.
• Experience using statistical software such as Minitab, JMP, or equivalent.
• Experience leading or participating in Lean Manufacturing, Six Sigma, Kaizen, Value Stream Mapping, or other continuous improvement methodologies is preferred.
• Experience supporting product introduction, process scale-up, design transfer, and manufacturing process improvements.
• Strong project management, technical writing, analytical thinking, communication, and cross-functional leadership skills.

Key Responsibilities

• Lead IQ/OQ/PQ and Process Performance Qualification (PPQ) activities, including the development of validation protocols, reports, and Master Validation Plans.
• Design and develop in-process and receiving inspection systems, control plans, sampling plans, and inspection methods for manufacturing processes and components.
• Generate, review, and approve equipment documentation, preventive maintenance and calibration procedures, manufacturing work instructions, and process control documentation.
• Lead manufacturing projects from concept through implementation while coordinating activities across Manufacturing, Quality, Research & Development, Regulatory Affairs, Supply Chain, and external suppliers.
• Apply Design of Experiments (DOE), PFMEA, risk assessments, Statistical Process Control (SPC), Measurement System Analysis (MSA), and Root Cause Analysis methodologies to optimize manufacturing processes and improve product quality.
• Drive Lean Manufacturing and continuous improvement initiatives to increase process capability, improve yield, reduce cycle time, enhance throughput, lower manufacturing costs, and improve equipment performance.
• Provide technical leadership for manufacturing technologies, including laser welding, heat bonding, injection molding, automation systems, vision systems, tooling, fixtures, test methods, and equipment qualification activities.
• Lead or participate in manufacturing process validation, equipment qualification, technology implementation, and process optimization projects.
• Manage Change Control activities, CAPA implementation, nonconformance investigations, and product and process scale-up while ensuring compliance with site Quality Systems and regulatory requirements.
• Mentor junior engineers and provide technical guidance to project teams while operating with a high degree of independence.

Quality Expectations

• Demonstrate a strong commitment to patient safety, product quality, and regulatory compliance by adhering to all applicable quality procedures.
• Maintain accurate and compliant documentation while promoting Quality System requirements and documentation discipline.
• Provide technical guidance to cross-functional teams to ensure compliance with internal procedures, regulatory expectations, and quality standards.