Starkey Hearing Technologies is a privately held, global hearing technology company headquartered in Eden Prairie, Minnesota. Founded by Bill Austin in 1967, Starkey is known for its innovative design, development and distribution of comprehensive digital hearing systems. Starkey is the only American-owned and operated provider of hearing technologies. We have more than 5,000 employees, operating in 24 facilities and doing business in more than 100 markets worldwide.
The Senior Operations New Product Specialist serves as the Operations Core Team representative for projects and programs to ensure outstanding product quality and successful product launch. The incumbent will enable the seamless introduction of new products into manufacturing while ensuring the manufactured product meets expectations for the customer and sustained manufacturability. This role will be the leader and facilitator for an Operations team of multiple internal functions during early product development through design transfer and post-launch.
Approach and Deployment
Facilitate the successful transfer of products into operations
Act as the key liaison between R&D and Operations
Accountable for the completion of transfer activities required for product commercialization, including DHR and DMR elements
Work with the Operations and Supply Chain teams to ensure that the demand, supply, and capacity plans meet requirements for validation and launch readiness
Manage the Operations risks and issues related to the product transfer, implementing preventative action where possible
Represent Operations on new product core teams
Work with product teams to accomplish needed Operations objectives and deliverables according to required processes, procedures and regulations
Collaborate with team members and stakeholders in solving problems and implementing solutions
Oversee Operations related readiness reviews, communicate recommendations and actions
Influence and guide product teams to avoid or mitigate manufacturing-related challenges
Analyze risk/tradeoffs and make recommendations of appropriate path forward
Make and execute recommendations for process improvements for the New Product Operations (NPO) team
Suggest, lead, and execute solutions related to business issues and opportunities related to NPO
Quickly identify barriers to progress and execute team plan for success in and out of specific events
Support Starkey Employee Corporate and/or Department Guidelines.
Check and verify quality.
Support corporate health and safety objectives.
React to change productively and handle other essential duties as assigned.
Minimum education, certification and experience requirements:
Minimum 5-7 years working in operations, manufacturing, process engineering, or related.
Minimum 3-5 years work experience in project orientated environment.
Expert in problem solving and continuous improvement tools and methodology, such as Six Sigma, Lean, and Kaizen or comparable business systems
Knowledge of ERP and PLM systems
Knowledge and experience in cGMP, ISO13485, and FDA QMS preferred
Skills & Abilities
Ability to work effectively in a team environment and coordinate multiple activities with a wide variety of disciplines within the organization
Willing to be hands-on in a manufacturing environment
Able to work with autonomy and prioritize work to manage several tasks at once without frequent direction.
Strong analytical skills
Influencer who can change peer behavior without direct reporting relationship
Exercise of authority or supervision over others:
Starkey Laboratories, Inc.