Principal Engineer, Medical Devices

Pinnaql, Inc.; Aibonito (PR); On-site; USD 110,000 - 150,000; Full time

Job summary

Validation & Engineering Group, Inc. seeks a Principal Engineer to provide technical leadership and support for Process & Product Technical Services within the Medical Devices business unit.

The role involves supporting manufacturing operations, leading engineering initiatives, and driving process and product improvements while ensuring regulatory compliance and operational excellence. The position requires collaborating with cross-functional teams, troubleshooting complex issues, and guiding

Qualifications

• Bachelor’s degree in Engineering or a related technical discipline.
• At least 3 years of relevant engineering experience, preferably in the medical device industry or another regulated manufacturing environment.
• Strong analytical, troubleshooting, problem-solving, and communication skills.
• Ability to work effectively with cross-functional teams and manage multiple priorities.

Responsibilities

• Provide technical guidance and engineering support for manufacturing processes and product-related activities.
• Lead process improvement initiatives to enhance product quality, operational efficiency, and manufacturing performance.
• Troubleshoot technical issues and support investigations related to manufacturing processes, equipment, and product performance.
• Collaborate with Quality, Manufacturing, Validation, and other cross-functional teams to resolve technical challenges.
• Support the development, implementation, and optimization of engineering procedures, processes, and technical documentation.
• Ensure engineering activities comply with applicable regulatory requirements, quality standards, and company procedures.
• Identify opportunities for continuous improvement, risk reduction, and process optimization.
• Share technical knowledge and support the development of engineering team members.

Skills

Analytical thinking

Troubleshooting

Cross-functional teamwork

Communication skills

Education

Bachelor’s degree in Engineering

Job description

Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.

We are seeking a Principal Engineer to provide technical leadership and support Process & Product Technical Services within the Medical Devices business unit. The role involves supporting manufacturing operations, leading engineering initiatives, driving process and product improvements, and collaborating with cross-functional teams to ensure regulatory compliance, operational excellence, and the achievement of business objectives.

Principal Engineer, Medical Devices

Description

• Provide technical guidance and engineering support for manufacturing processes and product-related activities.
• Lead process improvement initiatives to enhance product quality, operational efficiency, and manufacturing performance.
• Troubleshoot technical issues and support investigations related to manufacturing processes, equipment, and product performance.
• Collaborate with Quality, Manufacturing, Validation, and other cross-functional teams to resolve technical challenges.
• Support the development, implementation, and optimization of engineering procedures, processes, and technical documentation.
• Ensure engineering activities comply with applicable regulatory requirements, quality standards, and company procedures.
• Identify opportunities for continuous improvement, risk reduction, and process optimization.
• Share technical knowledge and support the development of engineering team members.

Qualifications

• Bachelor’s degree in Engineering or a related technical discipline.
• At least 3 years of relevant engineering experience, preferably in the medical device industry or another regulated manufacturing environment.
• Strong analytical, troubleshooting, problem-solving, and communication skills.
• Ability to work effectively with cross-functional teams and manage multiple priorities.
• Work Location and Schedule
  • On-site work at the designated manufacturing facility.
  • Occasional weekend work and additional hours may be required to support operational or project needs; these instances are expected to be rare.

At Validation & Engineering Group, people always come first. We believe that when you're empowered to do your best work, bold ideas thrive and real progress happens. This isn't just a job - it's an opportunity to make a meaningful difference by shaping the future of healthcare and technology alongside a purpose-driven, supportive team. Validation & Engineering Group is an equal opportunity employer. All applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability status.