October 3, 2024

Enhanced Compliance Inc.

Manufacturing Engineer II

ECI’s mission is to be the global leader of professional consulting services for the life sciences industry. Our clients lean on our diverse perspectives and decades of expertise to tackle their toughest challenges and we take pride in providing them transformative solutions with distinctive, sustainable and long term value. ECI boasts a proven track record of providing full product life cycle consulting on a variety of challenging and exciting projects. Our collaborative culture, welcoming team and flexible employment & benefit options allow us to maintain strong relationships with the most talented individuals in the life sciences industry.

The Manufacturing Engineer II will contribute on projects to provide solutions to engineering challenges and has the ability to effectively perform under supervision or minimal supervision, documents goals and objectives to monitor action plans. The Manufacturing Engineer II will also demonstrate knowledge and applies current quality, regulatory, and industry knowledge to project deliverables. Is focused on achievement, recursive and can identify engineering problems, anticipate client´s needs and utilizes analytical and conceptual thinking to provide innovative and creative solutions. He/she will demonstrate costumer service orientation and focus its work efforts on becoming the client´s “trusted advisor” by building trust and providing client satisfaction through effective responsiveness, punctuality, confidentiality, professionalism and responsibility. The Manufacturing Engineer II adapts to the changes in work and to the customer needs, communicates with assertiveness, has ability to handle difficult clients with diplomacy and demonstrate ability to create and maintain internal and external functional interpersonal relationships. He/she is proactive and uses projects and other opportunities to further develop technical, business and professional skills.

Bachelors degree in Engineering
3-5 years experience in the medical devices industry
Advanced computer skills including MS Office applications (Word/Excel/Power Point/Project/Visio)
Proficient in the use of Minitab statistical analysis
Experience with Solid Works, Pro E or Inventor, prototypes, 3D (desirable)
Familiar with electronic management documentation systems (desirable)
English: Fluent speaking, writing and reading

Successfully contribute to projects teams according to the engineering necessity of the client, including activities like product design and development, test of materials, preparation of specifications, process capability studies, research investigations, report preparation, process/test documentation, etc.
Experienced and proficient with quality documentation in order to develop, review and approve quality documentation such as: design verification, design validation, process validation, quality plans, standard operating procedures, and inspection procedures.
Identify device improvement opportunities of quality, cost, performance and contribute to projects to apply systematic problem-solving methodologies.
Identify, prioritize, communicate and resolve quality issues, build quality into all aspects of work by maintaining compliance to all quality requirements.
Fabrication and evaluation of materials, components, devices, text fixtures and prototypes.
Analyze and identify opportunities for continuous improvement in the process, and its respective implementation with minimal supervision.
Provide support in validations for the design area.
Collaborate with the compliance and monitoring of KPIs.
Work according to the guidelines of the EHS department.
Ensure that product and process development changes to existing products and manufacturing lines are conducted in compliance with the FDA Quality System Regulation, ISO 13485 Regulations and other applicable standards.
Maintains own project schedules and priorities, plans and organizes project assignments under supervision or minimal supervision.
Participate in meetings and presentations.
Work cohesively and maintain functional interpersonal relationships with internal and external customers.
Demonstrate customer service orientation, translate customer requirements into workable product ideas and solutions.
Adapt to the culture, policies and procedures of the client´s company, be recursive and create strategic alliances to facilitate completion of the assignments.
Maintain active communication with supervisor and client.