- Work on the validation of new medical device processes and equipment (IQ, OQ, PQ), ensuring compliance with regulatory standards (, ISO ). This includes developing and managing Master Validation Plans, protocols, and reports.
- Design and implement robust in-process and receiving quality control systems to guarantee the quality of new medical device processes and components.
- Collaborate closely with the Process Development team to streamline the qualification of new processes.
- Assist with developing statistical sampling plans and other procedures to ensure efficient process development.
- Develop clear and concise manufacturing instructions for newly established medical device processes.
- Become an expert on the equipment used in these processes. This includes generating equipment documentation (entries, evaluations, PM and calibration procedures) and defining the necessary gauges, tools, and testing equipment.
- Work effectively across departments, such as Quality Assurance and Regulatory Affairs, to ensure successful validation activities and overall process development goals for medical devices. Process Development
- Own and manage medical device process development projects from initial concept to successful implementation.
- Ensure projects meet deadlines and achieve objectives, driving efficiency and innovation in our manufacturing processes.
- Leverage your expertise in various medical device manufacturing technologies like Laser Welding, Stringing, and Injection Molding, as well as automated equipment (PLC/Servos/Pneumatics/Sensors). This knowledge will be crucial in designing and optimizing new processes.
- Utilize Design of Experiments (DOE) to analyze and optimize medical device processes.
- Interpret data to identify opportunities for improvement in efficiency, quality, and yield.
- Become a champion for continuous improvement.
- Proactively identify areas where medical device processes can be optimized and develop data-driven strategies to achieve these improvements.
- Mitigate risks in medical device manufacturing.
- Understand and evaluate potential risks associated with processes, then develop solutions and utilize PFMEA methodology to document the risk analysis.
- Foster collaboration across disciplines.
- Work effectively with engineers, scientists, and production personnel to achieve successful medical device process development.
- The ability to communicate technical concepts clearly, both verbally and in writing, will be essential for seamless collaboration and project success. Quality System:
- Maintains compliance with the Quality Policy and all other documented quality processes and procedures.
- Assures that the right resources (personnel, tools, etc.) are maintained to assure Quality System compliance and adherence to the client Quality Policy.
- Establishes and promotes a work environment that supports the Quality Policy and Quality System. Qualifications:
- Bachelor's degree in engineering (Mechanical, Industrial, or similar) with a minimum of years of experience in medical device process development or a related field
- Strong understanding of validation principles (IQ, OQ, PQ) and medical device quality systems (, ISO )
- Experience with Design of Experiments (DOE) and data analysis.
- Familiarity with various manufacturing technologies used in medical device production (, Laser Welding, Sterilization) is a plus.
- Excellent written and verbal communication skills
- Ability to work independently and as part of a team.
- Strong commitment to quality and patient safety
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Medical Device Process Development Engineer - Dorado, Puerto Rico - RCM Technologies, Inc.
Descripción
Title: Medical Device Process Development Engineer
Function: Develops and reviews documentation and procedures and provides automation systems testing and validation in support of Process Development and/or Manufacturing Process Engineering.
Length of Assignment: months full time contract
Location: Dorado, PR (On-Site)
Scope of Work:
RCM is seeking a highly motivated Process Development Engineer (Contract) for one of our manufacturing of medical device client in Dorado, PR. Their employees contribute to improving the quality of life for patients around the world.
Key Responsibilities:
Process Validation
About RCM:
RCM is a leading provider of IT Business Solutions and Engineering Services to over , clients in the commercial and government sectors. RCM partners with clients to define, implement and manage a broad range of technologies across multiple platforms, systems, and networks. Our broad geographic presence ensures that a proven and reliable tactical and strategic capability is available and deployable virtually everywhere in North America.
RCM is an equal opportunity employer.
Disclaimer
This job description is intended to describe the general nature and the level of the work being performed by the people assigned to this position. 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.
