Mechanical Engineer II - Continuation Engineering

Starkey Hearing; Eden Prairie (MN); On-site; USD 79,000 - 102,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

401(k) Match

Life Insurance

Disability Insurance

Paid Time Off

Holidays & Floating Holidays

Tuition Reimbursement

Job summary

Starkey Hearing is seeking a Mechanical Engineer II to lead and contribute to Continuation Engineering changes for hearing aid products and production tooling at our Eden Prairie, MN headquarters. You will design, validate, and implement mechanical updates to improve quality, reduce costs, and ensure supply chain continuity while collaborating with R&D, Quality, Supply Chain, and Manufacturing.

The role requires CAD proficiency (Pro-E/Creo preferred) and experience with design verification, FAI

Qualifications

• Bachelor of Science in Mechanical Engineering or related field; or equivalent.
• Minimum 1+ years of engineering experience in product development or manufacturing; hearing aid/medical device experience preferred.

Responsibilities

• Execute Continuation Engineering Requests (CERs) – Mechanical Scope.
• Lead and/or support 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 CERs involving 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 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; support electronics and programming integration where needed.
• Estimate fixture costs; analyze design methods for cost-effectiveness and manufacturability.
• Research and implement new materials and process technologies to support CE initiatives and production stabilization.

Skills

Independent work

Attention to detail

Cross-functional collaboration

Communication skills

Problem solving

Education

Bachelor of Science in Mechanical Engineering or related field

Tools

Pro-E/Creo CAD

MS Office

Engineering documentation tools

Job description

Starkey is hiring a Mechanical Engineer II - Continuation Engineering at its global headquarters in Eden Prairie, MN. This position under general supervision, the team member is responsible for executing mechanical engineering changes to released hearing aid products and production tooling within the CE organization. The Mechanical Engineer II – CE drives quality improvements, cost reductions, supply chain continuity, and manufacturing scalability initiatives by designing and validating updated mechanical components, assembly tooling, and fixtures. Has close collaboration with CE Electrical, Systems Verification, Quality, Supply Chain, R&D, and Manufacturing teams to ensure all changes maintain product integrity and comply with Starkey’s design control and regulatory requirements.

Starkey is a world leader in the manufacturing and distribution of advanced hearing technologies. We are in the business of connecting people and changing lives. Our teams come to work each day focused on ensuring people everywhere have the products and services they need to hear better and live better. Founded in 1967 by Bill Austin, Starkey is known for our cutting-edge hearing health innovations, industry-leading research and development, and not being afraid to push the edge of what’s possible. We are headquartered in Eden Prairie, Minnesota, have over 5,000 employees in 29 facilities across the globe, and do business in more than 100 markets worldwide.

Watch this video to see more of what sets Starkey apart.

https://youtu.be/9cUYwTlCepg?si=wkovx8_R_iINfrc6

Job Responsibilities

• 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 programing 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 t o confirm product requirements are met prior to release.
• Support First Article Inspection (FAI) review and disposition of new and update 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

Minimum Education, Certification And Experience Requirements

• 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.

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 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.

WORK CONTEXT

Working Conditions

• Standard office conditions
• Standard lab conditions

Equipment Operation

• Standard office equipment
• Test equipment, Computer PC, MS Office, Calculator, Machine Shop Tools, Caliper, CAD workstation (Pro-E/Creo)

Salary And Other Compensation

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

• Benefits: The following benefits for this position, subject to applicable eligibility requirements, include 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 bonus based upon performance results. There is no guarantee of payout.