Our client, a leader in the manufacturing of devices and components for major medical device companies, is looking for a Principal Application Engineer to join their organization.
They offer competitive compensation and excellent benefits, including 401k, health/dental, vision, and paid time off. They maintain a modern, clean, and safe facility with state-of-the-art equipment and dedication to continuous improvement. The company is registered with the FDA as a Class 2 and Class 3 Medical Device Manufacturer and is certified to ISO 13485.

SUMMARY OF POSITION:

Reporting to the Sr. Engineering Manager, this position will have direct responsibility for key production-related deliverables including, but not limited to Manufacturing plan; Capacity planning; COGS estimation; Process validations; Capital equipment specifications and procurement; Production line set-up, as well as coordinate the launch of new products into production. The company manufactures parts via high precision metal machining, finishing, assembly, and anodize processes for Medical Devices.

QUALIFICATIONS:

• Bachelor’s degree (mechanical engineering, biomedical engineering, or related) required, with a related advanced degree preferred.
• Minimum of 7 years’ experience within a regulated industry (preferably in a Medical Device or Aerospace Manufacturer).
• Project management experience - plan, development and execution.
• Ability to read drawings and specifications containing GD&T.
• Familiarity with technologies and methods used to define how products are to be manufactured, how to conduct analysis, and meeting quality and compliance standards.
• Extensive experience with transferring multi-disciplinary products from development to production.
• Possess a high attention to detail.
• Proficiency in SolidWorks
• Proficient in the use of Microsoft Office, and Adobe products.
• Experience associated with continuous improvement activities, including participations and/or facilitating Kaizen events using lean manufacturing principles.
  Job Type: Full-time

Schedule:

• Monday to Friday

Application Question(s):

• Do you have at least 7 years of experience with in a regulated industry? (Examples: Medical Device, Aerospace)
• Are you able to program various pieces of CNC equipment?
• Are you proficient in SolidWorks?
• What annual salary are you targeting?

Work Location: In perso

• This position may have direct-reporting responsibilities for daily activities of site Engineering personnel (responsibility dependent on geographic organizational structure).
• Develop and perform installation, operational and process qualifications for customer manufacturing processes in cooperation with cross-functional engineering teams per project requirements.
• Ability to program various pieces of CNC equipment across multiple sites as directed to support critical and/or high-value projects milling, turning, and grinding, Multi spindle, Multi Axis and Swiss style programs for manufacture of medical devices- implants and instruments.
• Analyze drawings, design models, and sketches to determine dimensions and configuration of cuts, selection of cutting tools, machine speeds, and feed rates according to shop processes, customer specifications, and machine capabilities.
• Actively participate in process development projects and DFM with internal and external teams
• Revise programs to eliminate instruction errors, omissions, and update programs with new technology/methods to improve efficiency; meet customer delivery dates
• Coordinate with Quality Engineering to help facilitate the development of Process Control Plans, Manufacturing Inspection Plans, and gaging/fixturing requirements.
• Create 1st pcs and in-process inspection plans.
• Design fixtures for post processing operations.
• Adapts machine or equipment design to facility and production conditions.
• May incorporate inspection and test requirements into the production plan.
• Inspects performance of machinery, equipment, and tools to verify their efficiency, and investigates and initiates corrective action of problems and deficiencies to ensure product quality.
• Develops manufacturing processes that are applicable to statistical process control and may develop those techniques.
• Provides guidance to engineering regarding design concepts and specification requirements to best utilize equipment and manufacturing techniques.
• Identify and support business growth opportunities and present recommendations to management.
• May be required to act as lead technical problem solver within area of specialization.
• Develop and deliver presentations to communicate status, problem resolution or promote related business products.