Medical Device R&D Process Development Engineer

Akkodis; Bloomington (IN); On-site; USD 52,052 - 74,135; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) plan

Job summary

A leading engineering firm is seeking a Medical Device R&D Process Development Engineer for a 12-month contract in Bloomington, IN. This role involves designing and optimizing manufacturing processes for new medical devices, ensuring compliance with regulations and quality standards. Candidates should possess a relevant engineering degree and at least 3 years of experience in a regulated environment. The position offers competitive hourly pay and a comprehensive benefits package including medical, dental, and 401(k) plan.

Qualifications

• Minimum of 3 years experience in Class II/III medical device manufacturing or GMP-regulated environment.
• Experience in creating process validation documents and design for manufacturing.
• Knowledge of medical device quality standards ISO 13485/FDA practices.

Responsibilities

• Collaborate with engineers on new process designs and implementations.
• Maintain process documentation for new products.
• Define and procure new equipment for manufacturing processes.

Skills

Process validation

Lean manufacturing principles

Problem-solving skills

Analytic skills

Effective communication

Education

PhD, MS, or Bachelor's degree in Engineering

Tools

Microsoft Office (Word, Excel, Visio, PowerPoint, MS Project)

3D modeling software (Creo, SolidWorks)

Job description

Job Overview

Akkodis is seeking a Medical Device R&D Process Development Engineer for a 12‑month contract in Bloomington, IN. The engineer will design and optimize manufacturing processes for new medical devices, evaluating innovative options based on technical and economic feasibility, cost‑effective systems, and compliance with government regulations and industry standards.

Rate

Rate Range: $45.80/hour to $45.80/hour (negotiable based on experience, education, geographic location, and other factors).

Responsibilities

• Collaborate in a team of engineers focused on design, development, and implementation of new processes within company facilities and/or with third‑party suppliers for new device designs.
• Collaborate with R&D, Operations, and Production engineering to ensure effective completion of all activities associated with transfer to manufacturing of an R&D Engineering project/objective.
• Execute methods needed for efficient and effective process development (design for manufacturing, test method validation, process validation, process capability, lean manufacturing, equipment selection, and specification development).
• Apply a risk‑based approach during development, implementation, and validation of all processes.
• Maintain process documentation (PFMEA’s, Production Instructions, Drawings, etc.) for new products.
• Compare costs and benefits when choosing in‑house versus supplier options.
• Define, identify, and procure new equipment for manufacturing processes.
• Complete projects within specific timelines and meet performance expectations.
• Adhere to the Quality Management System and its processes to meet FDA 21 CFR 820, ISO 13485, and other applicable regulatory requirements.
• Maintain company quality and quantity standards.
• Demonstrate effective communication skills, both oral and written.
• Show excellent problem‑solving skills and the ability to work collaboratively and independently with minimal supervision.
• Remain calm and receptive in fast‑paced situations.

Desired Qualifications

• PhD, MS, or Bachelor’s degree in Engineering or Engineering Technology, or equivalent experience.
• Experience in creating process validation documents, design for manufacturing, statistics, and lean manufacturing principles.
• Experience in identifying process variation, process capability, and evaluation and DOE’s.
• Experience commissioning and qualification of new processes and equipment.
• Minimum of 3 years experience in Class II/III medical device manufacturing or GMP‑regulated environment.
• Knowledge of process validation, design for manufacturing, statistics, lean manufacturing principles.
• Knowledge of medical device quality standards ISO 13485/FDA practices, GMP and similar regulated industry standards.
• Experience using analytic skills and problem‑solving.
• Working knowledge of Microsoft Office Software (Word, Excel, Visio, PowerPoint, MS Project).
• Preferred knowledge of 3D modeling software (Creo, SolidWorks, etc.).

Benefits

Benefit offerings available include medical, dental, vision, life insurance, short‑term disability, additional voluntary benefits, an EAP program, commuter benefits, and a 401(k) plan. Associates may also be eligible for paid leave, including paid sick leave and holiday pay where applicable.

Equal Opportunity Employer

Veterans, Disabled; Equal Opportunity Employer. The Company considers qualified applicants under the California Fair Chance Act, Los Angeles City Fair Chance Ordinance, and Los Angeles County Fair Chance Ordinance.