Manufacturing Engineer Job in Budd Lake, New Jersey US
Our client has filed a 510(k) seeking FDA Approval to market their new product in the United States. They are hopeful that US approval can occur in the second half of 2012.
In this context, the initial phase of this role will be to perform a technology transfer from our existing engineering and manufacturing contractor to establish in-house capabilities for service, repair and refurbishment of systems to support the US launch.
The position will be located in Northwestern New Jersey after a 3 month training and transition period in Foxboro Massachusetts. The position will require occasional travel to meet with vendors.
JOB DESCRIPTION
Senior Manufacturing Engineer
Responsibilities:
•Learn all aspects of the current manufacturing process at current contract manufacturer to facilitate the technology transfer to the New Jersey facility. The process will start with relocation of refurbishment and service of products.
•Take a lead role in establishing the new service facility – from site layout, equipment selection and qualification, document release, etc.
•Provide engineering support to the refurbishment, trouble-shooting and repair activities.
•Work on ongoing process development and process improvements at the existing contract manufacturing facility for the first generation product.
•Take an active or lead role in CAPA and MRB. Work with design engineering to implement Engineering changes.
•Provide input into Generation Two design and development.
•Participate in the manufacturing set-up for Generation Two.
Requirements:
•Knowledge and skills typically acquired through a BS/BA in Mechanical Engineering or similar discipline with at least 7-10 years experience in FDA Medical Device Regulated industry.
•Knowledge of Cardiovascular catheters and ablation technology (class II medical devices) and electronic and software medical device compliance requirements is a plus.
•Knowledge of current FDA medical device guidance and regulatory and ISO requirements and trends affecting medical devices.
•Detail oriented, well organized and able to work independently and in teams.
•Excellent interpersonal, verbal and written skills.
•Prior experience in start-up environment is a plus.
US Citizenship or Green Card Holder required. MUST be willing to start the assignment at the clients contract manufacturer based in Foxboro, MA.