Senior Manufacturing Engineer (Contractor)

RCM Technologies • United States, United States • 3w ago

Full Time Contract Title: Senior Manufacturing Engineer (Contractor) Location: Dorado Puerto Rico (On-site) Length of Contract: (6-12 months) Position Description: The Senior Manufacturing Engineer leads enterprise manufacturing operations support, validation strategy, implementation of manufacturing processes, documentation generation, process optimization, and cross-functional technical execution. The role operates with a high degree of independence, provides technical leadership to project teams, and mentors junior engineers or technical team members as needed. Responsibilities:

Validation & Compliance: Lead IQ/OQ/PQ and process performance qualification activities; develop validation protocols, reports, and master validation plans. Maintain strict compliance with site quality procedures, supporting change control, CAPA, and nonconformance investigations.

Quality Systems Design: Design and develop in-process and receiving inspection systems, control plans, sampling plans, and inspection methods for components and manufacturing processes.

Documentation: Generate, review, and approve equipment documentation, PM/calibration procedures, manufacturing instructions, and process control documentation.

Project Management: Manage enterprise manufacturing projects from concept through implementation; lead cross-functional technical collaboration with Manufacturing, Quality, R&D, Regulatory, Supply Chain, and external suppliers.

Process Optimization: Apply DOE, PFMEA, risk analysis, SPC, MSA, and root-cause methodologies to characterize, optimize, and improve manufacturing processes.

Continuous Improvement: Lead Lean Manufacturing and Six Sigma initiatives to improve yield, cycle time, cost, throughput, process capability, and equipment performance.

Technical Direction: Provide technical expertise for manufacturing technologies such as laser welding, heat bonding, injection molding, vision systems, fixtures, tooling, test methods, automation, and equipment qualification.

Qualifications:

Industry Experience: 5-7+ years in manufacturing, process, validation, or quality engineering within an FDA-regulated environment (Medical Device/Pharma).

Regulatory Knowledge: Strong working knowledge of 21 CFR Part 820, GMP, and ISO 13485.

Technical Background: Electrical or mechanical engineering background applied to automated or semi-automated manufacturing systems (automation/controls, tooling, fixtures).

Methodologies: Proficiency in DOE, FMEA/PFMEA, CAPA, root-cause investigation, and statistical analysis (Minitab or JMP preferred).

Lean Culture: Experience with Lean Manufacturing, Six Sigma, Kaizen, and value stream mapping.

Education & Certifications:

Bachelor's degree in Mechanical, Electrical, Industrial, Manufacturing, Biomedical Engineering, or a related technical field.

Equal Opportunity Employer: RCM is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. Pay Transparency: RCM believes in transparency and fairness in compensation. We are committed to providing our employees with competitive salaries that reflect their skills, experience, and contributions to our organization. As part of our commitment to pay transparency, we want to provide you with as much information as possible about our compensation practices. About RCM: RCM is publicly traded on Nasdaq under the symbol RCMT. RCM is a business and technology solutions provider with world-class talent in key market segments. We help design, build, and enable the Industries of Tomorrow, Today. Operating at the intersection of resources, critical infrastructure, and modernization of industries, RCM is a provider of services in Life Sciences, Data & Solutions (IT), Healthcare, Engineering, Aerospace & Defense, and Process & Industrial. Disclaimer: This job posting is intended to describe the general nature and the level of the work to be performed. It is not intended to include every job duty and responsibility specific to the position. RCM reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.

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