Job Description

Akkodis is Seeking a Design Manufacturing Engineer - Medical Device as a contractor for the location of Arden Hills MN. It is a contract Position for 12 months. Ideally Looking for a candidate with experience in Medical Device Manufacturing Industry.

Pay Range: $50 - $60/hour; The rate may be negotiable based on experience, education, geographic location, and other factors.

Duties

• Understanding and application of design engineering concepts and tools including Design Failure Modes and Effects Analysis (DFMEA), Design Verification & Validation, Benchmarking, Test Method Validation, and Design Transfer.

• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues including CAPA work.

• Review and approve quality records, including product specifications, design verification test protocols, and design verification test reports.

• May lead or contribute to collaborative problem solving of complex technical issues using disciplined, methodical techniques. Tools used include DMAIC, Root Cause Analysis, 5 Whys, Cause & Effect Diagram, and Is-Is Not.

• Creates, maintains, and enhances cross-functional team partnerships. Provides guidance regarding technical strategies and approaches; works cross-functionally and across multiple sites in identifying and resolving technical issues.

• Focuses on continuous improvement by championing and fostering the execution of projects within the local and divisional Design Assurance organizations.

• Fosters a diverse and inclusive workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives.

• Monitors and ensures compliance with company policies and procedures.

• Demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.

Minimum Qualifications

• Bachelor's degree in an engineering or related discipline with 5+ years of relevant experience

• Experience in Medical Device industry; Knowledgeable in Quality System Regulations, Medical Device Regulation, ISO 14971 and ISO 13485 Quality Standards with a focus on design controls and design optimization.

• Proficient with Microsoft Office tools including Word, Excel, PowerPoint, and Outlook.

• Ability to collaborate and influence across multiple, cross-functional teams

• Demonstrated technical problem-solving & data analysis capabilities

Preferred Qualifications

• Experience in design engineering or process development, including test method validation, process validation, and continuation engineering.

• Experience writing specifications, test protocols, and technical reports.

• Demonstrated use of Quality tools and methodologies including DFMEA, DOE, Brainstorming, Root Cause Analysis, and 5 Why’s.

• Experience in post-market quality, including returned product analysis and corrective and preventative action (CAPA).

• Experience with Class III Medical Devices, including Electrical Medical Equipment (EME) or Active Implantable Medical Devices (AIMD).

• Adaptable and effective collaborator in a team environment or in self-directed work.

• Strong ability to successfully multi-task and demonstrate adaptability

• Strong communications skills. Effectively present complicated technical information to small and large audiences, from peers to senior leadership, with varying levels of technical expertise.

If you are interested in this role, then please click APPLY NOW. For other opportunities available at Akkodis, or any questions, please contact Punit Pathak at 610 445 8219 or Punit.pathak@akkodisgroup.com.

Equal Opportunity Employer/Veterans/Disabled

Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, an EAP program, commuter benefits, and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as 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

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

· San Francisco Fair Chance Ordinance

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