Product Development Manager - Medical Device

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

Job Description

Departmental Manager providing direct management of engineers, supervisors, and technicians. Allocates resources based upon departmental plans & budgets. Responsible for hire/fire decisions within their department. Submits departmental budgets, performance / productivity targets and reports on results. Measured against performance plan goals and objectives.

The primary role of the Product Development Manager is to plan, organize and direct engineers to meet company objectives for design, development of new products and make improvements to existing products by performing the following duties personally or through subordinates. This manager ensures that all engineering activities are completed on time and conform to the standards as established by design control procedures.

Duties and Responsibilities

• Supervise the team of engineers within the product development department.
• Responsible for the development of new products as determined by the company’s product development roadmap. Continually researches for new methods or components to enhance or improve existing products.
• Prepare and/or review engineering change requests; coordinate cross functional teams to determine feasibility, develop and oversee preparation and implementation of all engineering change notices and document change control.
• Responsible for maintaining and implementing processes and procedures covered by design control.
• Assist quality and compliance in the implementation of the quality system including but not limited to support in conducting risk analysis, closing customer complaints, CARs, internal audits, and other activities covered by the quality system.
• Assist manufacturing operations with development of processes, tooling, molds, and design transfer necessary to produce new products.
• Provide customer service and sales & marketing departments with orientation and training on new products, and assist with preparation of sales presentations, service/repair methods, and marketing literature.
• Perform other duties as assigned.

Required Qualifications

• Bachelor’s degree in mechanical engineering.
• Minimum 5+ years of engineering experience within the medical device industry.
• 3+ years in a leadership role within product development, engineering, design, etc.
• Experience with GMP and other regulatory compliance requirements.
• Experience with design & development of medical devices within a design control process.
• Prior hands-on customer interaction and proven experience understanding the voice of the customer.
• Change management: willing to make hard fact-based decisions, comfortable with anuninstructed and changing environment.
• Skilled at developing new ideas from both a product and process perspective.
• Demonstrated practical application of design FMEA, value engineering, and design for manufacturability concepts.
• Extensive experience in 3D CAD modeling and 2D dimensioning using Solidworks.

Physical / Mental Demands

• Working conditions are normal for an office environment.
• Work may require weekend and evening work.
• Work may require travel.
• Physical activity includes sitting, walking, standing, bending, squatting, reaching above shoulders and lifting up to 40 pounds.
• Work under stress in a fast-paced environment.
• Must be alert, able to concentrate, and use good judgment.

Company Description

IMI specializes in tamper-evident technologies that help prevent drug diversion and misuse. Our solutions are essential to hospital and pharmacy drug security programs.