Sustaining Engineer

Sustaining Engineer

 

MFG ONE, LLC, a medical-device manufacturer headquartered in Chantilly, Virginia, is seeking a Sustaining Engineer to join its team. 

 

Position Objective:

 

Generate creative, manufacturable design solutions to difficult production controlled design challenges utilizing good design practices capable of meeting our demanding requirements and specifications.

 

 Essential Functions (Responsibilities):

 

1.        Establish links with R&D, Manufacturing and Quality to monitor production processes, Troubleshooting/identifying and prioritize the problems that develop in the course of production.

2.        Determining design-related causes and assist with design changes as required.

3.        Participate in the Failure Analysis and Correction Teams to identify and prioritize customer problems.

4.       Tasks will include process qualification of new manufacturing lines, assisting manufacturing with resolution of build issues, quality issues, and, vendor selection and support.

5.       This individual will, in performing the above tasks, be required to prepare drawings, prototypes, specifications, bill of materials, Engineering Change Notices, test protocols and reports and perform qualification tests.

6.        Create/modify new or existing 3D Inventor models as well as detailed drawings.

7.        Generate Document change requests (DCR), Document change notices (DCN).

8.        Monitor failure data generated to identify product improvements in future designs.

9.        Obtain year over year cost savings through Value Engineering Change Proposals.

10.      Work with customers to maintain/update processes to meet changing technical environments of industrial and FDA requirements.

11.      Work with manufacturing engineers and line technicians to guide and assist in fabrication, assembly and installation of designed systems.

12.       Participate in Value Engineering Teams for products to identify and prioritize design changes for product enhancement.

13.      Projects are typically fast paced and require a dedicated design effort.  This environment dictates the ability to learn quickly and work closely with others to coordinate the defined efforts.

14.     Ensure compliance with FDA Regulations and ISO 13485 Guidance using cGMP.

15.     Perform all duties in a safe manner.

16.     Perform other duties as assigned by Management. 

 

Minimum Education and Experience Required:

 

Bachelor's degree (B.S.M.E. or B.S.Mfg.E. preferred) from four-year college or university and 4-5 years related experience and/or training; or equivalent combination of 12 years of education and experience.

 

Basic Skill and Ability Requirements:

 

1.        Use of Inventor as primary design CAD system, familiarity with solid modeling, sheet metal and drafting modules.  

2.       Solid interpersonal skills with experience in customer/supplier relations.

3.       Experience with ISO 13485 Quality Operating Systems.

4.       Experience with FDA Regulations (21 CFR 820).

5.       Ability to communicate effectively and efficiently through eexcellent communication and technical writing skills.
6.       Must have strong work ethic, sense of urgency and a high energy level.

7.       Self-starter: bias for action, results oriented.

8.       Ability to work effectively to meet deadlines.

9.       Experience in customer relations.

10.     Ability to solve complex problems by using past experience, six sigma problem solving techniques and innovative thinking. Computer skills with proficiency in MS Office applications required.

11.     Ability to work with a diversified work in a team-oriented environment. 

 

Reports to: Director of Manufacturing

 

MFG ONE offers an attractive compensation package that includes a competitive salary and benefits, along with the chance to contribute and grow in a team-oriented, dynamic, and professional environment.  MFG ONE is an Equal Opportunity Employer.