Product Development Manager - Medical Device

Medical Device Manufacturing Co; Pompano Beach (FL); On-site; USD 100,000 - 150,000; Full time

Job summary

IMI, a medical device firm in the United States, seeks a Product Development Manager to oversee engineers and technicians, allocate resources, and guide new product development under design controls.

The role emphasizes leadership, change management, and collaboration with quality, manufacturing, and sales. Strong GMP experience and CAD proficiency are essential for success in this position.

Qualifications

• Bachelor’s degree in mechanical engineering is required.
• Minimum 5+ years of engineering experience in the medical device industry.
• At least 3 years in a leadership role within product development or engineering.
• Experience with GMP and regulatory compliance requirements.
• Experience with design and development of medical devices under a design control process.
• Hands-on customer interaction and understanding the voice of the customer.
• Change management in a fast-paced environment.
• Ability to develop innovative product and process ideas.
• Demonstrated use of design FMEA and value engineering.

Responsibilities

• Supervise the team of engineers within the product development department.
• Lead development of new products per the product development roadmap; research methods to improve products.
• Prepare and review engineering change requests; coordinate cross-functional teams.
• Maintain and implement processes covered by design control.
• Support quality system activities including risk analysis and internal audits.
• Assist manufacturing with processes, tooling, molds, and design transfer for new products.
• Provide customer service and sales/marketing with training on new products and prepare marketing literature.
• Perform other duties as assigned.

Skills

Leadership experience

GMP knowledge

Voice of the customer

Change management

Design for manufacturability

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.