Senior Engineer

Akkodis is seeking a Senior Engineer for a Contract with a client in Blue Ash, OH. The ideal candidate will be responsible for leading medical device lifecycle change projects, supporting design verification, risk management, supplier quality, and manufacturing validation activities to ensure product quality and regulatory compliance.

Rate Range: $34/hour to $37/hour; The rate may be negotiable based on experience, education, geographic location, and other factors.

Senior Engineer Job Responsibilities include:

• Lead product lifecycle management and engineering change projects from concept through implementation while ensuring compliance with quality and regulatory requirements.

• Coordinate cross-functional teams including Engineering, Quality, Regulatory, Manufacturing, Supply Chain, and external suppliers to deliver project objectives on time.

• Support design verification and validation (V&V) activities, including test planning, protocol development, execution, data analysis, and technical documentation.

• Drive risk management, root cause investigations, and corrective action initiatives using methodologies such as ISO 14971, DFMEA, PFMEA, CAPA, and 8D.

• Manage supplier qualifications, component development, process validation (IQ/OQ/PQ), and manufacturing transfer activities to ensure product quality and readiness.

• Review engineering drawings, specifications, GD&T requirements, and change documentation while communicating project status, risks, and recommendations to key stakeholders and leadership.

 

Required Qualifications:

• Bachelor’s degree in biomedical engineering, Mechanical Engineering, Manufacturing Engineering, Quality Engineering, Life Sciences, or a related technical field.

• 6-8+ years of experience in Medical Device Engineering, Product Development, Quality Engineering, Supplier Quality, or regulated manufacturing environments.

• Strong expertise in Medical Device Product Lifecycle Management (PLM), Design Controls, Engineering Change Management (ECO/ECN/ECR), Risk Management (ISO 14971), and Design Verification & Validation (V&V).

• Proven experience with Quality Management Systems (ISO 13485, FDA 21 CFR Part 820/QMSR), supplier qualification, process validation (IQ/OQ/PQ), root cause analysis, and cross-functional project leadership within regulated industries.

 

If you are interested in this role, then please click APPLY NOW. For other opportunities available at Akkodis, or any questions, feel free to contact me at Deep.Kumar@akkodisgroup.com.

Pay Details: $34.00 to $37.00 per hour

Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, 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.

Equal Opportunity Employer/Veterans/Disabled

Military connected talent encouraged to apply

To read our Candidate Privacy Information Statement, which explains how we will use your information, please navigate to https://www.akkodis.com/en/us/candidate-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
• San Francisco Fair Chance Ordinance

Massachusetts Candidates Only: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.