Open Position: Product Engineer

Department:

• Engineering

Overview:

INRAD is a growing developer, manufacturer, and marketer of innovative medical devices. We are seeking a talented engineer to join our team and contribute to the development and launch of several innovative new products.

The Product Engineer will be responsible for leading and managing new product development projects from start to finish, designing new medical devices, developing and launching new product manufacturing processes, supporting regulatory submissions, supporting operations engineering projects, building new supplier partner relationships, and other engineering projects as necessary.

Main Responsibilities:

This position at INRAD Inc. entails numerous responsibilities including, but not limited to the following:

• New product development, including all activities pertaining to the conceptualization, design, and development of new medical devices in accordance with INRAD’s design control procedure, quality system, and GMPs.
• Developing project plans and managing project timelines and budgets. Ensuring communication and accountability of key project milestones and deadlines.
• Establishing and managing relationships with suppliers
• Maintenance and manufacturing support activities for INRAD legacy products
• Identifying and addressing additional training needs
• Initiating and Investigating Complaint, Variance, Corrective and Preventive activities
• Contributing to process improvements
• Implementing cost-saving measures
• Writing, Reviewing and approving device history record documentation and drawings
• Performing Calibration/Preventive Maintenance
• Design Control / Process and Design Verification and Validation
• Working with Customers and Suppliers
• Technical support for regulatory submissions (i.e. 510k)
• Performing Risk Analysis
• Implementing new equipment
• Additional projects as assigned by management

Job Qualifications:

• Four (4) year college degree or higher in Mechanical Engineering or Biomedical Engineering with a background in Mechanical Engineering
• FMEA, SPC, and Strong PC Skills
• Proficient in mechanical drafting and 3D modeling software (Solid Works is preferred)
• Additional technical training is preferred

Job Experience:

• Some experience desired, but not required
• Previous Medical Device development experience preferred

Skills / Competencies:

• Understand Good Manufacturing Processes (GMP’s)
• Ability to read, understand, and follow specifications
• Ability to follow verbal and written instructions
• Proficient mathematical skills
• Understanding tolerances and variations
• Able to read / create drawings
• Understand production methods, manufacturing techniques, statistical methods
• Ability to multi-task proficiently
• Strong project management skills
• Ability to use measuring devices/hand tools
• Demonstrate good judgment and analytical skills
• Proficient computer skills
• Good interpersonal skills
• Data collecting and charting
• Performing multiple tasks with minimal supervision
• Good communication skills (written and verbal)
• Good attention to detail
• Ability to adapt to changing environment/priorities
• Mechanical aptitude
• Proficient Mechanical Drafting skills
• Proficient in mechanical drafting and 3D modeling software (Solid Works is preferred)

Physical Requirements:

• Good vision
• Good hand-eye coordination
• Able to lift 50 lbs
• Able to sit or stand for four (4) hours at a time
• Able to work with / assemble small components
• Moderate twisting, bending, and lifting
• Able to travel on occasion