Manufacturing Engineer III

Overview

OverviewResonetics is a global leader in advanced engineering, prototyping, product development, and micro manufacturing, driving innovation in the medical device industry. With rapid expansion across all our locations, we continue to push the boundaries of technology while fostering a dynamic, employee-centered culture. Our commitment to excellence and continuous improvement makes Resonetics an exciting place for professionals passionate about shaping the future of micro-manufacturing and being part of something bigger.We are looking to add a Manufacturing Engineer III. This role will be responsible for managing Process Transitions through Validation to Manufacturing control. This individual will be responsible and manage Process Improvement/Optimization and Process Development projects utilizing design for manufacturing and Lean Six Sigma methodologies. The ideal candidate will have strong skills in working with our R&D team and Production (Sustaining) teams to help get new products moved into production.This role will work closely with project managers, Production personnel and/or directly with customers to evaluate and develop new or existing opportunities. This may include developing simple automation projects (including vision, fixtures, basic programming, etc), resulting in customer development samples to high volume commercial product.Join Resonetics and be part of a team that’s redefining medical device manufacturing. If you’re passionate about innovation and thrive in a fast-paced environment, we’d love to hear from you.

Responsibilities

• Responsibilities

  • Designs manufacturing processes, procedures and production layouts for assemblies, equipment installation, processing, machining and material handling.
  • Designs arrangement of machines within plant facilities to ensure most efficient and productive layout.
  • Designs sequence of operations and specifies procedures for the fabrication of tools and equipment and other functions that affect product performance.
  •  Finalize inspection procedures including defining inspection sample size and inspection techniques/gages for each lot of parts.
  •  Write work instructions and train production staff on procedures.
  •  Draft process risk assessment (PFMEA), process flow charts, and control plans.
  •  Perform process validation (IQ/OQ/PQ/MVP/TMV) and gage R&R activities, as required.
  •  Ensure bill of materials and job router accuracy.
  •  Solidify tooling documentation for production release using SolidWorks, including tool design updates for manufacturability and tool drawing creation/modification.
  •  Review process metrics to identify areas of improvement during the transfer process.
  •  Ensure that accurate and complete QMS/DMR records are generated through the change order process, including documentation of both finished components and raw materials.
  •  Monitor transfers post-release for lessons learned or process improvements.
  • Assist in driving manufacturing engineering projects to completion, including making sure the work is done satisfactorily and timely.
  •  Other duties as assigned.

  Required Qualifications

  • Minimum of 4 years of experience of Manufacturing/Process Engineering experience or equivalent.
  •  B.Sc. degree in Mechanical Engineering or another relevant manufacturing-focused engineering field.
  •  Experience with Process/Product Transitions through Validation to Manufacturing.
  • Process industries – a significant advantage
  • Experience with project costing/budgeting
  •  General understanding of statistical analysis for purposes of equipment validation.
  • Strong problem-solving, influence and communication skills.
  • Written and verbal communication skills in English.
  • Certifications such as Six Sigma/Green belt or Lead Auditor (ISO 13485) are a plus.

   

  Preferred Qualifications

  •  Tooling Design
  •  Experience with Laser processes and optics
  •  Experience with precision motion / vision systems
  •  Project Management Professional (PMP)
  •  ISO 13485:2003, ISO 9001:2008