Advanced Manufacturing Engineer
Michigan, Grand Rapids-Muskegon-
Our client, a medical device manufacturing company in the Grand Rapids area is looking for an Advanced Manufacturing Engineer to join their team for a 9+ month contract position.
Work with project managers and lead engineers to support new products as well as sustain medical devices currently on the market
Proposes possible solutions to design problems and assists in their implementation.
Follows prescribed procedures and, under direct supervision, conduct analyses to test design for structures, systems and components.
Becomes familiar with the company Design Control Methodology and develop regulatory acceptable documentation to support business continuity of existing products.
Becomes familiar manufacturing capabilities of the company and leverages them in existing products or updated designs of existing products.
Develop test methods and cost estimates for products
Creates risk management documents including design analyses, FMEAs, and Usability studies.
Coordinate sample creation and conditioning.
Understands and follows all internal policies and procedures related to area of responsibility including design control, testing, and document control
Applies current Medical Device Industry standards to new products (ex. Risk Management) Interfaces with vendors, manufacturing facilities and various internal groups to resolve design and manufacturing issues of products
Provides general technical assistance to various inter departments/individuals as necessary to support day to day business and/or problem solving
Travels as needed to other company sites, vendors, or other business partners (10-25%).
EDUCATION and/or EXPERIENCE:
Bachelor of Science Degree in Engineering or closely related 4 year Technical degree is required with 3 or more years of Engineering and/or product development experience.
Or Associate of Science Technology degree with 5 plus years of relevant work experience.
Experience working on R&D or manufacturing projects in the medical/similar industry.
Experience with product testing, usability, risk management, etc.
Experience working with plastics materials and processing is a plus.
Regulated industry experience that includes FDA and ISO requirements is a plus.
SKILLS, KNOWLEDGE AND EXPERIENCE REQUIRED:
Experience in product testing, data collection, & statistical analysis.
Demonstrated capacity for solving problems through creative designs and solutions.
Able to take initiative on projects and present solutions to problems for approval from Manager or Senior level Engineers
Able to perform root cause analysis and implement effective corrective actions on projects of limited scope
Able to build stable internal and external working relationships
Project Management able to effectively manage and complete multiple projects simultaneously
Able to effectively adhere to project budgets, schedules and risks.
Ability for detail orientation and accuracy when completing documentation and written communications
Computer Skills Excellent computer skills including but not limited to Microsoft Office Suite