Mechanical Engineer II - Continuation Engineering

Job Responsibilities

• Execute Continuation Engineering Requests (CERs) – Mechanical Scope
• 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.
• Plan and perform design verification testing on mechanical changes to confirm product requirements are met prior to release.
• 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.
• Create and maintain accurate CAD models, drawings, and Engineering Change Orders (ECOs) in compliance with Starkey documentation procedures.
• 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.
• Collaborate 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.

Minimum Education, Certification And Experience Requirements

• Education: Bachelor of Science in Mechanical Engineering or related field;
• 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: 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.