Medical Device R&D Engineer

Akkodis; Bloomington (IN); Hybrid; USD 85,000 - 121,000; Full time

Benefits offered by this job

Medical

Dental

Vision

Life Insurance

Short-term Disability

Additional benefits

EAP program

Commuter Benefits

401K plan

Paid Sick Leave

Job summary

Akkodis is seeking a Medical Device R&D Engineer for a 12-month contract in Bloomington, IN. Hybrid position: 3 days onsite, 2 days remote. Responsible for design, testing, and documentation of new medical products under DV&V processes, including FDA design documentation.

Qualification highlights include 3–5 years in design/validation/verification, FMEA, Creo, and Minitab, with strong communication and problem-solving abilities to collaborate across global teams.

Qualifications

• 3–5 years of experience in design, validation and verification, documentation and design control.
• Experience with risk management and FMEA.
• Strong communication and problem-solving skills.

Responsibilities

• Design new product ideas and prototypes.
• Coordinate verification/validation activities and manage test data.
• Document final product design and maintain design files.
• Assist in FDA design documentation.
• Plan pre-production runs and coordinate production updates.
• Engage with vendors and physicians for materials and evaluations.
• Attend trade shows to source materials and network with partners.

Skills

Design Verification

FMEA

Minitab

Creo

MS Office

Tools

Creo

Minitab

Job description

Akkodis is seeking a Medical Device R&D Engineer for a 12-month contract job with conversion opportunity with a client in Bloomington, IN. You will design, test and technically document the feasibility, construction and production process of new and/or changed medical products. This is a hybrid position - 3 days onsite/ 2 days remote.

Rate Range: $75.00/hour to $75.00/hour; The rate may be negotiable based on experience, education, geographic location, and other factors.

Medical Device R&D Engineer job responsibilities include:

• 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.
• Assist 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.
• 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

Desired Qualifications:

• 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.Ability to work independently and remain self-motivated.

Equal Opportunity Employer/Veterans/Disabled

Benefits:

• medical
• dental
• vision
• life insurance
• short-term disability
• additional voluntary benefits
• EAP program
• commuter benefits
• 401K plan
• Paid Sick Leave or any other paid leave required by Federal, State, or local law
• Holiday pay where applicable

Disclaimer: These benefit offerings do not apply to client-recruited jobs and jobs that are direct hires to a client.

To read our Candidate Privacy Information Statement, which explains how we will use your information, please visit https://www.akkodis.com/en/privacy-policy.

The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable:

• The California Fair Chance Act
• Los Angeles City Fair Chance Ordinance
• Los Angeles County Fair Chance Ordinance for Employers