Senior Manufacturing Engineer (Medical Devices)

Full Time
Charlotte, NC 28273
Posted
Job description

If you are looking for a career at an extraordinary company in an exciting field, Medical Murray is the place for you! We are looking for team players with a can-do attitude to share in our vision and corporate values. Medical Murray offers competitive salaries, a comprehensive benefits package, and an energetic work environment.

Position Summary:

The Senior Manufacturing Engineer position performs equipment and process transfer from product development to production as well as improvements in equipment, tooling, and processes for ongoing production in the production department in support of the department objectives to provide goods and services that meet customer's requirements for quality, quantity, and timeliness. The position will take on multiple projects of high complexity and have a mixture of direct support of customers and sustaining engineering.

For your benefit(s):

  • Competitive wage
  • Health and Dental insurance
  • Company paid Vision, Life, and Disability insurance
  • 401k contribution
  • 18 days of PTO
  • TeleDoc program
  • Identity protection
  • HSA eligible health insurance

Essential Duties and Responsibilities:

  • Responsible to follow Medical Murray Quality system, including all applicable SOP's included in the Manufacturing Training Matrix
  • Management of projects, including communication with customers, involving complex design or processes
  • Support R&D efforts with assembly and engineering during regulatory phase
  • Work with R&D in transferring project to manufacturing Lead transfer of products into production following transfer checklist
  • Coordinate production support of transfer builds including materials and assembly labor
  • Manage production lines during transfer builds Development of manufacturing processes for acceptable throughput and yield to achieve cost targets
  • Provide problem resolution on identified projects
  • Train assemblers on assembly procedures during transfer phase and to support process changes they originate beyond transfer
  • Train production personnel in equipment and line start setups
  • Communicate with vendors to support production and address issues
  • Manage process validation including master validation plans, IQ, OQ, PQ, gauge R&R, and software validation
  • Perform IQ, OQ, and PQ associated with assigned projects
  • Coordination of process qualification and operational qualification of processes used in manufacturing products
  • Coordination of design of custom equipment, fixtures, devices, and processes to improve the quality and reduce cost of manufactured products
  • Selection, acquisition, setup, and installation qualification of new equipment, including creation of PM procedure as necessary
  • Support of equipment maintenance, as appropriate per skills and knowledge, manage escalation to Technology Manager
  • Support or perform equipment re-entry to production
  • Engage and handoff activities to production
  • Review of safety issues with equipment and processes and implementation of procedures and equipment modifications
  • Production line layout
  • Annual risk analysis and DMR updates

Qualifications:

  • BS in Industrial or Mechanical Engineering or equivalent
  • MS in relevant engineering program, preferred
  • 5+ years of experience with sustaining and process engineering, contract manufacturing preferred
  • ISO experience, cGMP and ISO 13485 preferred
  • Project management experience is highly preferred to plan and conduct complex development projects.
  • Strength in problem-solving and decision making
  • High energy level, attention to detail, and a sense of urgency
  • Strong communication (written and verbal) and computer skills
  • Hands-on
  • Ability to juggle multiple projects of increasing complexity

Skills, Knowledge, Abilities:

  • Strength in problem-solving and decision making
  • High energy level, attention to detail, and a sense of urgency
  • Ability to juggle multiple projects of increasing complexity
  • Computer skills including MS Office, Solidworks, or alternative CAD program
  • Knowledge of lean manufacturing techniques Skills with statistics, preferably experience with DOEs, Minitab
  • Strong customer interaction skills

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