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Job description
Who we want
- Quality-focused team drivers. People who push their team to deliver the highest quality products and solutions in a timely manner.
- Network builders. Managers who build connections with other functions, teams, and business units and coordinate cross-functional collaboration.
- Motivated product launchers. People who bring strategic direction and drive for execution to ensure products are developed and launched with precision.
What you will do
As an Associate Engineering Manager, Advanced Quality you will be responsible for leading a team of Advanced Quality Engineers supporting new product development within Stryker Orthopaedic Instruments. You will have cross functional responsibility and work closely with business unit leadership to deliver predictable, quality product launches.
- You will develop talent, advocate for, and drive team engagement.
- You will develop, coordinate, implement, and maintain QA systems for new products and business development.
- You will lead and coordinate the activities of Advanced Quality Engineers that are part of cross-functional NPD project teams and will provide Quality leadership for the broader NPD team.
- You will oversee and support Quality led tangibles such as risk management, human factors engineering, and design validation as well as adherence to design controls and QMS requirements.
- You will oversee and support process development and PPAP activities necessary to ensure manufacturing and supplier quality.
- You will train others in QA/GMP/SDLC related topics.
- You will be expected to operate autonomously and make decisions that are best for the business.
- You will evaluate the performance of the Advanced Quality Engineering team based on pre-established performance parameters.
- You will recruit, select, and on-board top talent
- You will develop talent within team to increase performance
- You will actively address performance issues on team
- You will deliver regular and timely feedback
- You will maintain a high level of team engagement
What you need
- Bachelor’s degree in mechanical, electrical, or biomedical engineering, or related discipline.
- Master's Degree or equivalent preferred.
- Minimum of 6 years work experience.
- 5 years of experience in a regulated, new product development environment preferred.
- Experience in new product development, design controls, risk management, and HFE
- Demonstrated knowledge and application of regulatory requirements, including ISO, FDA, and international requirements.
- Demonstrate technical knowledge of medical device product lines.
- Demonstrated written, verbal, listening, communication, and team-building skills.
- Demonstrated ability to collaborate effectively with and lead cross-functional teams.
- Demonstrated ability to effectively prioritize and manage multiple project workloads.
- Demonstrated experience with trending and analysis reporting.
- Demonstrated leadership skills.
- Demonstrated process improvement and management skills.
- Experience with recruiting, people development.
- Knowledge of Quality Concepts (e.g. CAPA, Audits, Statistics).
- Influence across the organization.