Mechanical Engineer II - Continuation Engineering

Starkey Hearing Technologies; Eden Prairie (MN); On-site; USD 78,540 - 102,000; Full time

Benefits offered by this job

Medical Insurance

401(k) with company match

Paid time off

Job summary

Starkey Hearing Technologies in Eden Prairie, MN is seeking a Mechanical Engineer II – Continuation Engineering to execute CERs, design production tooling, and lead design verification for released hearing aid products.

You will collaborate across CE with R&D, Quality, Supply Chain and Manufacturing to improve quality, reduce costs, and scale production while maintaining design control and regulatory compliance.

Qualifications

• Bachelor's degree in Mechanical Engineering or related field required.
• Minimum 1+ year of relevant engineering experience in product development or manufacturing.
• Hearing aid or medical device experience preferred.

Responsibilities

• Execute CERs for mechanical changes to released products and assemblies.
• Design and maintain production tooling and fixtures using CAD systems.
• Perform design verification and support validation activities for mechanical changes.
• Create and maintain CAD models, drawings, and release documents in compliance with procedures.
• Collaborate cross-functionally with R&D, Quality, Supply Chain, and Manufacturing.

Skills

Independent work

Engineering analysis

Attention to detail

Cross-functional teamwork

Decision making

Communication

Self-motivation

Technology awareness

Education

Bachelor of Science in Mechanical Engineering

Tools

Pro-E/Creo CAD

MS Office

Job description

Mechanical Engineer II – Continuation Engineering

Starkey is hiring a Mechanical Engineer II – Continuation Engineering at its global headquarters in Eden Prairie, MN. This position reports to general supervision and is responsible for executing mechanical engineering changes to released hearing aid products and production tooling within the CE organization. The role drives quality improvements, cost reductions, supply chain continuity, and manufacturing scalability through the design and validation of updated mechanical components, assembly tooling, and fixtures, working closely with CE Electrical, Systems Verification, Quality, Supply Chain, R&D, and Manufacturing teams to ensure compliance with design control and regulatory requirements.

Job Responsibilities

• Execute Continuation Engineering Requests (CERs) – Mechanical Scope
  • Lead and/or support CER execution involving mechanical changes to released hearing aid products and assemblies
  • Evaluate and implement solutions for quality improvement, cost reduction, supply chain continuity, and manufacturing scalability
  • Collaborate with R&D on CERs that involve product specification changes, ensuring proper design control and approval processes
  • 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 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; support electronics 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 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 identify and address mechanical risks for CE changes
• Documentation and Design Control
  • Create and maintain accurate CAD models, drawings, and Engineering Change Orders 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 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

Minimum Education, Certification and Experience Requirements

• Education: Bachelor of Science in Mechanical Engineering or related field (minimum)
• Experience: Minimum 1+ year of relevant engineering experience in a product development or manufacturing environment; hearing aid or medical device experience preferred

Knowledge / Technical Requirements

• 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 understanding of acoustics and vibration highly desirable

Competencies, Skills & Abilities

• Ability to work independently on mechanical designs and manage tasks to completion
• Proven ability to perform complex engineering analysis and calculations
• Strong attention to detail and quality‑oriented mindset
• Proven ability to work well in a cross‑functional team environment
• Ability to work with minimal guidance to make decisions and report progress clearly
• Professional communication and interpersonal skills required
• Excellent verbal and written communication skills required
• Must be self‑motivated and able to work in fast‑paced, deadline‑driven environments
• Ability to keep current with new technologies, materials, and manufacturing trends

Salary and Other Compensation

The target rate for this position is between $78,540 and $102,000 per year. Factors that may affect starting pay within this range include geography, skills, education, experience, and other qualifications of the successful candidate.

Benefits (subject to eligibility): medical, dental, and vision insurance; 401(k) retirement plan with company match; company‑paid life and short‑term disability insurance; long‑term disability insurance; employee assistance plan; hearing aid benefits; paid time off, paid holidays, paid floating holidays, paid volunteer service day, paid paternity and maternity leave; and tuition reimbursement.

This position is eligible for a performance‑based bonus. Payout is not guaranteed.

Equal Employment Opportunity

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities. This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, review the Know Your Rights notice from the Department of Labor.