Engineering Manager

Apollo Technical has an immediate need for a Engineering Manager with Medical Device experience in the Palmetto FL area

This is a full time direct hire position with benefits

The engineering manager should have good technical skills, experience of working in medical device production

environment, and deep understanding of engineering task in a production site: facility, infrastructure and production

equipment including maintenance. Support production by overcoming technical problems.

This position should be familiar with the engineering requirements in the medical device industry.

The engineering manager holds the responsibility to build the engineering team, work closely with the engineering team and

Ensure the equipment is working with no disruption, solve problems, maintain the facility and

equipment, specify, install, and qualify new equipment.

This role will be responsible for technology transfer, training the employees, and implementing the technology in

production.

At the first year the engineering manager will be part of establishing the US site project, involved in design and construction project, and will be required to perform the engineering and maintenance task by himself.

Key Responsibilities:

 Responsible for the site engineering team including process engineer, validation and maintenance.

 Support production team. Problems solving.

 Be part of the US site establishing team.

 Familiar with GMP, FDA and ISO requirements– including Controlled design changes, validation protocols,

equipment and processes qualification, write WI, etc.

 Familiar with qualification and validation requirements, write protocols and monitor the execution.

 Work closely with the operations team specific with the engineering team and R&D.

 Allocate service provider to maintain infrastructure, AC, building, equipment suppliers, spare part suppliers.

 Quick response to production stops due to equipment/process fault.

 Active and responsibility for technology transfer from the main production site to the US.

 Be hands on oriented.

Qualifications (Education, Skills, and Experience; Required):

Required:

 7 years of proven experience as an engineer in the medical device industry

 3 years of experience in engineering management position.

 High technical skills.

 Experience working in global companies.

 Experience in scaling up manufacturing.

 Good leadership skills.

 Strong analytical and project management skills.

 Mechanical engineering degree or similar.