Process Development Engineer

Full Time Contract

Title or Role: Process Development Engineer

Location: Onsite - Dorado PR

Length of Contract: 6 to 12 months

Position Description:

The Process Development Engineer plays a critical role in developing, documenting, and validating manufacturing processes and automated systems. This position supports both Process Development and Manufacturing Engineering initiatives to ensure patient safety, product quality, and compliance with our client Quality Policy.

Responsibilities:

• Lead Validation Documentation: Develop, review, and execute process validation protocols and reports (IQ, OQ, PQ) for new processes or equipment.
• Support New Process Qualification: Work closely with the Process Development team to efficiently qualify new processes , including assistance with statistical sampling plans and design of experiments (DOE).
• Risk Analysis & Mitigation: Understand, evaluate, and develop solutions to minimize risks associated with manufacturing processes, including the use of PFMEA methodology for risk analysis documentation.
• Develop Manufacturing Documentation: Generate and maintain essential manufacturing documents, including Manufacturing Instructions for new processes and equipment documentation (entries, evaluations, PM/calibration procedures).
• Design Quality Systems: Design and develop robust in-process and receiving quality systems for new processes and components to ensure product integrity.
• Project Management: Be able to manage process development projects from conception to implementation, ensuring all project deadlines and objectives are successfully met.
• Process Optimization: Identify and recommend areas for improvement in processes and develop strategies to optimize the efficiency, quality, and/or yield of developing manufacturing processes.
• Cross-Functional Collaboration: Effectively collaborate and communicate technical concepts with other engineers, scientists, and production personnel to achieve development objectives and solve problems.

Qualifications

• Proven professional experience of 2–5 years in Process Development, Manufacturing Engineering, or a related role within the medical device industry (preferred) or a highly regulated environment.
• Demonstrated experience writing and executing Validation protocols and reports (IQ/OQ/PQ).
• Solid experience utilizing statistical tools and methodologies, such as Design of Experiments (DOE), to characterize and optimize processes.
• Familiarity with risk management tools, specifically the Process Failure Mode and Effects Analysis (PFMEA) methodology.
• Working knowledge of various manufacturing technologies (e.g., Laser Welding, Heat Bonding, Vision Systems, Staking) and general experience with automated equipment (PLC/Servos/Pneumatics/Sensors).
• Experience defining and specifying gages, tools, and equipment for new test methods.
• Strong written and verbal communication skills (English and Spanish preferred) to effectively convey technical concepts.
• Demonstrated ability to manage technical projects and adhere to established timelines.

Education & Certifications:

• A Bachelor's degree in Engineering (e.g., Mechanical, Electrical, Industrial, Biomedical) or a related technical field is required .

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 Technologies, Inc. (Nasdaq: RCMT) 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.