Manufacturing Engineer- Process Development

RCM Technologies • United States, United States • 15h ago

Full Time Contract Title: Manufacturing Engineer - Process Development Location: Dorado, Puerto Rico Length of Contract: 12 months with potential to extend Position Description:

The Manufacturing Engineer provides vital technical leadership to the Process Development team, ensuring the seamless transition of products from concept to commercialization. This role is dedicated to optimizing production area operations, enhancing equipment performance, and correcting process parameters to eliminate non-conformities. By bridging the gap between R&D and full-scale manufacturing, this position ensures that production goals are met without compromising the highest standards of product quality and patient safety.

Key Responsibilities

Operational Excellence & Troubleshooting: Support daily manufacturing support and continuous improvement projects. Execute complex equipment troubleshooting and perform Root Cause Analysis (RCA) to resolve production bottlenecks and non-conforming product issues.

Process Innovation: Drive technical activities for current and next-generation product programs. Develop improved manufacturing processes that align with the company's strategic objectives and deliver findings through formal technical reports and presentations.

Advanced Problem Solving: Apply fundamental engineering principles and innovative methodologies (such as DMAIC or 8D) to solve a wide range of technical challenges, from standard mechanical issues to Client system failures.

Strategic Collaboration: Cultivate an extensive internal and external network of resources. Act as a key contributor in cross-functional project teams to ensure the successful delivery of project milestones.

Validation & Compliance (IQ/OQ/PQ): Spearhead process and equipment validation activities. Author and manage Master Validation Plans (MVP) and execute Installation, Operational, and Process Qualifications in strict adherence to GxP standards.

Data-Driven Development: Partner with Process Development teams to qualify new processes using robust statistical sampling plans, ensuring high process capability and repeatable yields.

Documentation: Author precise Manufacturing Instructions (MI), Standard Operating Procedures (SOPs), and visual work instructions for new and optimized processes.

Qualifications & Education

Professional Experience: 2-5 years of progressive experience in a manufacturing or process development environment, ideally transitioning products from pilot to full-scale production.

Technical Proficiency: Expert understanding of engineering principles and hands-on experience with statistical analysis software (Minitab or JMP preferred).

Preferred Background: Proven experience in a highly regulated industry (Medical Device, Pharmaceuticals, or Aerospace). Lean Six Sigma Green Belt or Black Belt certification is highly desirable.

Soft Skills: Exceptional project management capabilities and interpersonal skills for effective interaction with internal teams, stakeholders, and external vendors.

Quality System Requirements

Maintain a primary commitment to patient safety and product quality through 100% compliance with the Quality Policy and all documented quality processes.

Ensure that appropriate resources (personnel, calibrated tools, and validated systems) are maintained to uphold Quality System integrity.

Foster a work environment that actively promotes and supports the Quality System and continuous improvement culture.

Education :

Bachelor's Degree in Engineering (Mechanical, Biomedical, Chemical, or Industrial).

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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