Mechanical Engineer II - Continuation Engineering

Job Category: Engineers

Requisition Number: MECHA
007422

• Full-Time
• On-site

EP World Hdqtrs, 6700 Washington Ave. So., Eden Prairie, MN 55344, USA

• Execute Continuation Engineering Requests (CERs) – Mechanical Scope
  • Lead and/or support the execution of CERs involving mechanical changes to released hearing aid products and assemblies
  • Evaluate and implement mechanical solutions for quality improvement, cost reduction, supply chain continuity, and manufacturing scalability initiatives.
  • Collaborate with R&D for any CERs that involve product specification changes, ensuring proper design control and approval processes are followed.
  • Support manufacturing site expansions, production transfers, and global operations scaling from a mechanical engineering perspective.
  • Contribute to continuous improvement initiatives using production data, warranty feedback, and field quality data.
• Design and Maintain Production Tooling and Fixtures
  • Design new and updated assembly tooling and fixtures for hearing aid product assembly using CAD systems (Pro-E/Creo preferred)
  • Build and validate prototypes; specify materials and finishes appropriate to production and performance requirements.
  • Work with vendors and Manufacturing to develop, procure, and qualify tools and processes.
  • Design assembly machines and fixtures for production and R&D use as required; support electronics and programming integration where needed.
  • Estimate fixture costs; analyze and compare design methods for cost-effectiveness and manufacturability.
  • Research and implement new materials and process technologies to support CE initiatives and production stabilization.
• Design Verification and Validation
  • Plan and perform design verification testing on mechanical changes to confirm product requirements are met prior to release.
  • Support First Article Inspection (FAI) review and disposition of new and updated mechanical parts and assemblies.
  • Aid prototype and production debugging to ensure design intent is maintained for form, fit, and function.
  • Support design validation activities for mechanical changes requiring partial or full V&V cycles.
  • Participate in DFMEA reviews and updates to ensure mechanical risks are identified and addressed for CE changes.
• Documentation and Design Control
  • Create and maintain accurate CAD models, drawings, and Engineering Change Orders (ECOs) in compliance with Starkey documentation procedures.
  • Ensure accurate and timely creation of engineering and production release documents.
  • Maintain all design documentation consistent with Starkey’s design control procedures and applicable regulatory requirements.
  • Support regulatory documentation and homologation submissions as required for mechanical engineering changes.
• Cross-Functional Collaboration
  • Act as the mechanical engineering technical interface on CE project teams, coordinating with Electrical, Systems Verification, Quality, Supply Chain, Operations, Manufacturing, and R&D.
  • Represent CE Mechanical Engineering in project meetings, design reviews, and change review boards.
  • Present mechanical design change concepts, verification results, and technical recommendations at CE design reviews.
  • Interface with internal and external suppliers to develop and implement new mechanical processes and technologies in support of CE goals.
  • Provide technical guidance and direction to support engineers and technicians on the CE team as needed.
• Other duties as assigned

• Education
  • Bachelor of Science in Mechanical Engineering or related field; OR
• Experience
  • Minimum 1+ years of relevant engineering experience in a product development or manufacturing environment; hearing aid or medical device experience preferred.

• Proficiency with MS Office required.
• Proficiency with CAD workstation required:
  Pro-E (Creo) preferred.
• Familiarity with product development best practices (DFM, DOE, DFMEA, Lean PD) preferred.
• Knowledge of materials, injection molding processing, and manufacturing processes desired.
• Knowledge of geometric dimensioning and tolerancing (GD&T) desired.
• Knowledge of statistical process control (SPC) desired.
• Intermediate…