Medical Device R&D Engineer 2

Job Responsibilities

• Design new product ideas as assigned by VP of Engineering
• Build and test new product prototypes
• Coordinate and execute verification/validation efforts including creating and managing test requests, reviewing test protocols and reports, manage test inventory and samples, troubleshoot test issues with external laboratories, support overall DV&V planning and execution, and ensure documentation is complete and compliant throughout the process.
• Document the final product design. Maintain a design file for each new product and turn that file over at product completion for permanent records.
• Aid in writing design and specification documentation for FDA application
• Initiate and oversee the pre-production run of new products. Plan the ongoing production of the product. Consult with Production personnel for device changes/updates as necessary.
• Call on vendors to assess raw materials. Call on physicians to discuss product ideas or evaluations.
• Attend various trade shows to source raw materials or to attend Company exhibitions.

Requirements

Must work and interact effectively and professionally with and for others throughout various levels of the global organization. Ability to remain calm and receptive in fast paced situations. Must strictly adhere to safety requirements. Must maintain company quality and quantity standards. Must have effective oral and written communication skills. Excellent problem-solving skills and ability to work in collaborative and independent work situations and environments with minimal supervision.

Qualifications

• Minimum 4-year degree in Engineering/Technology
• Three to five years of experience with design, validation and verification, documentation, design control, standards assessment, risk management, FMEA, testing - i.e. tensile, torque, etc.
• Proficiency with MS Office and Minitab. Design experience with Creo highly preferred.
• Hands on product development and testing experience required (Feasibility/ Bench/ Tensile/ Leak/ etc.)
• Proven problem-solving skills.
• Excellent written and verbal communication skills.
• Good manual dexterity.
• Ability to work independently and remain self-motivated.
• Light travel – maybe once a quarter.

Desired Qualifications

• Minimum 4-year degree in Engineering/Technology
• Three to five years of experience with design, validation and verification, documentation, design control, standards assessment, risk management, FMEA, testing - i.e. tensile, torque, etc.
• Proficiency with MS Office and Minitab. Design experience with Creo highly preferred.
• Hands on product development and testing experience required (Feasibility/ Bench/ Tensile/ Leak/ etc.)
• Proven problem-solving skills.
• Excellent written and verbal communication skills.
• Good manual dexterity.
• Ability to work independently and remain self-motivated.
• Light travel – maybe once a quarter.

Pay

$75.00 per hour

Benefits

• Medical
• Dental
• Vision
• Life Insurance
• Short-term Disability
• Additional Voluntary Benefits
• EAP Program
• Commuter Benefits
• 401K Plan