Beschreibung
Abiomed, a leading medical technology company specializing in advanced heart recovery and support systems, is seeking a skilled and motivated Process Controls Engineer to join our dynamic team in Danvers, MA.
Abiomed, part of Johnson & Johnson MedTech, is a leading provider of medical devices that provide circulatory and respiratory support, with a mission of recovering hearts & saving lives. Abiomed's "Patients First!" culture drives our skilled workforce and strong relationships with clinicians. Our innovative product portfolio and robust pipeline provide us the incredible opportunity to bring lifesaving technology to more patients around the world than ever before. Founded in 1981, Abiomed has a proven track record for growth, integrity and innovation.
I Am Abiomed | I Am Heart Recovery | Patients First!
As a Process Controls Engineer at Abiomed, you will play a pivotal role in ensuring the safe, efficient, and reliable operation of our manufacturing processes and equipment. You will collaborate with cross-functional teams and leverage your technical expertise to develop and optimize process control systems, drive continuous improvement initiatives, and support the production of life-saving medical devices.
Responsibilities:
- Develop and implement process control strategies: Design, configure, and optimize process control systems to monitor, regulate, and enhance manufacturing processes, ensuring compliance with regulatory requirements and industry standards.
- Automation system design: Collaborate with the engineering team to design and implement automation solutions for manufacturing equipment and processes, integrating software, hardware, and control systems.
- Troubleshooting and maintenance: Identify and resolve process control issues, perform root cause analysis, and develop preventive maintenance strategies to minimize downtime and maximize operational efficiency.
- Continuous improvement: Drive continuous improvement efforts by analyzing process data, identifying areas for optimization, and implementing innovative solutions to enhance productivity, quality, and safety.
- Process validation: Support process validation activities, including protocol development, execution, and documentation, ensuring compliance with regulatory guidelines and company standards.
- Cross-functional collaboration: Collaborate with cross-functional teams, including Manufacturing, Quality Assurance, and Research and Development, to provide technical support, optimize processes, and ensure smooth production operations.
- Documentation and compliance: Maintain accurate documentation, including control system specifications, standard operating procedures, and change control documentation, ensuring compliance with regulatory and quality standards.
- Training and support: Provide training and technical support to operators, maintenance personnel, and other team members on process control systems and equipment usage, troubleshooting, and best practices.
Befähigungen
Qualifications:
- Education: Bachelor's degree in Electrical Engineering, Process Control Engineering, or a related field. Master's degree is a plus.
- Experience: Minimum of 4 years of experience in process controls engineering or a similar role, preferably in a regulated industry such as medical device manufacturing or pharmaceuticals.
- Process control systems: Strong knowledge of process control systems, including distributed control systems (DCS), programmable logic controllers (PLC), and human-machine interface (HMI) software.
- Automation and instrumentation: Proficiency in automation system design, programming, and troubleshooting, including experience with industrial control networks, instrumentation, and process sensors.
- Regulatory compliance: Familiarity with regulatory requirements, such as FDA regulations (e.g., 21 CFR Part 820) and international standards (e.g., ISO 13485), governing the design, validation, and documentation of manufacturing processes.
- Analytical skills: Excellent analytical and problem-solving abilities, with a data-driven approach to process optimization and troubleshooting.
- Communication and collaboration: Strong interpersonal and communication skills, with the ability to collaborate effectively with cross-functional teams and stakeholders at all levels of the organization.
- Self-motivated and adaptable: Proactive, results-oriented mindset with the ability to work independently, manage multiple priorities, and adapt to changing project requirements.
Note: This job description is intended to convey information essential to understanding the scope of the Senior Manufacturing Validation Engineer role at Abiomed. It is not exhaustive and may be subject to change or modification based on the company's needs.
Abiomed is an Equal Opportunity Employer committed to a diverse workforce. Abiomed will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, gender identity, national origin, ancestry, age, sexual orientation, gender identity, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law. Abiomed maintains a drug-free workplace.