Location: Dorado, PR
Job Type: Contractor
Contract Term: 6–12 months
Experience Level: Senior
Required Experience: 5–7+ years
Job Summary
We are seeking a Senior Manufacturing Engineer – Contractor to lead manufacturing operations support, validation strategy, implementation of manufacturing processes, documentation generation, process optimization, and cross-functional technical execution in a regulated manufacturing environment. This role requires a high degree of independence, technical leadership, and the ability to mentor junior engineers or technical team members as needed.
Key Responsibilities
- Lead IQ/OQ/PQ and process performance qualification activities, including 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 components and manufacturing processes.
- Generate, review, and approve equipment documentation, preventive maintenance/calibration procedures, manufacturing instructions, and process control documentation.
- Manage manufacturing projects from concept through implementation and lead cross-functional technical collaboration with Manufacturing, Quality, R&D, Regulatory, Supply Chain, and external suppliers as applicable.
- Apply DOE, PFMEA, risk analysis, SPC, MSA, and root-cause methodologies to characterize, optimize, and improve manufacturing processes.
- Lead Lean Manufacturing and continuous improvement initiatives to improve yield, cycle time, cost, throughput, process capability, and equipment performance.
- Provide technical direction for manufacturing technologies such as laser welding, heat bonding, injection molding, vision systems, fixtures, tooling, test methods, automation, and equipment qualification.
- Support change control, CAPA, nonconformance investigations, and product/process scale-up activities while maintaining compliance with applicable quality procedures.
Qualifications
- Bachelor’s degree in Mechanical, Electrical, Industrial, Manufacturing, Biomedical Engineering, or a related technical field.
- 5–7+ years of experience in manufacturing engineering, process engineering, validation engineering, or quality engineering within an FDA-regulated environment.
- Strong working knowledge of 21 CFR Part 820, GMP, ISO 13485, and documentation practices required in regulated manufacturing environments.
- Electrical and mechanical engineering background applied to automated or semi-automated manufacturing systems.
- Experience with automation/controls, tooling, fixtures, test method development, equipment qualification, and manufacturing process validation.
- Proficiency in DOE, FMEA/PFMEA, CAPA, root-cause investigation, statistical analysis, and process capability tools; experience with Minitab, JMP, or equivalent preferred.
- Experience with Lean Manufacturing, Six Sigma, Kaizen, value stream mapping, or other continuous improvement methodologies preferred.
- Experience supporting product introductions, process scale-up, design transfer, and improvements to existing manufacturing processes.
- Strong project management, communication, technical writing, analytical, and cross-functional leadership skills.
Quality Expectations
The selected candidate must demonstrate commitment to patient safety and product quality by complying with applicable quality procedures, maintaining proper documentation discipline, and supporting Quality System compliance while providing technical guidance to others as needed.
Work Location: In person
