Mechanical Engineer II - Continuation Engineering

Location

Eden Prairie, MN 55344, USA

Starkey is hiring a Mechanical Engineer II - Continuation Engineering at its global headquarters in Eden Prairie, MN. This position, under general supervision, requires the team member to execute mechanical engineering changes to released hearing aid products and production tooling within the CE organization.

• 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,…