Medical Device Product Development Lead

Medical Device Manufacturing Co; Florida; On-site; USD 120,000 - 190,000; Full time

Job summary

IMI specializes in tamper-evident technologies for drug security, seeking a Departmental Manager to lead engineers and technicians, allocate resources, and guide hire/fire decisions within the department.

The Product Development Manager will organize and direct engineers to meet company objectives for design and development of new products, ensuring timely completion and compliance with design control procedures.

Qualifications

• Bachelor’s degree in mechanical engineering.
• Minimum 5+ years of engineering experience in the medical device industry.
• 3+ years in a leadership role within product development.
• Experience with GMP and other regulatory compliance requirements.
• Experience with design & development of medical devices within a design control process.

Responsibilities

• Supervise the team of engineers within the product development department.
• Develop new products per roadmap; continually researches methods or components to enhance products.
• Prepare and review engineering change requests; coordinate cross functional teams for changes.
• Maintain and implement processes and procedures covered by design control.
• Assist quality and compliance with the quality system activities including risk analysis and audits.
• Assist manufacturing with development of processes, tooling, molds, and design transfer for new products.
• Provide training and support to sales/marketing on new products and prepare literature.
• Perform other duties as assigned.

Skills

Leadership

GMP knowledge

SolidWorks

Voice of customer

Design FMEA

Regulatory compliance

Education

Bachelor’s degree in mechanical engineering

Tools

SolidWorks

Job description

IMI specializes in tamper-evident technologies for drug security, seeking a Departmental Manager to lead engineers and technicians, allocate resources, and guide hire/fire decisions within the department.

The Product Development Manager will organize and direct engineers to meet company objectives for design and development of new products, ensuring timely completion and compliance with design control procedures.