Engineering Manager
Primary Purpose of the Role:
The Senior Engineering Manager is responsible for leading and developing the Manufacturing Engineering teams across New Product Introduction (NPI) and Sustaining Engineering. This role ensures the stability and continuous improvement of existing product lines by driving process optimization, cost efficiency, and quality enhancements. The manager will uphold regulatory compliance, support product lifecycle management, and cultivate a culture of operational excellence and continuous improvement. Collaboration with cross-functional teams is essential to meet customer expectations and achieve strategic business objectives.
Key Responsibilities:
- Provide strategic leadership to cross-functional engineering teams focused on NPI and sustaining engineering, aligning technical execution with business growth and operational excellence.
- Enhanced the Talent Lifecycle Review (TLR) process by implementing a 9-box framework, improving succession planning and stakeholder engagement across AMS.
- Directed the successful transfer and scale-up of new products into manufacturing, ensuring robust process validation, manufacturability, and regulatory compliance.
- Led initiatives to improve yield, reduce cost of goods sold (COGS), and enhance product quality and reliability across mature product lines.
- Achieved a 31-day reduction in salaried time-to-fill by introducing structured intake meetings and standardizing hiring processes, significantly improving recruitment efficiency and quality.
- Spearheaded an enterprise-wide onboarding initiative, increasing completion rates from 10% to 94% through rigorous tracking, site-level coaching, and executive engagement.
- Mentored and developed engineering and talent acquisition team members into subject matter experts, strengthening site-level support and technical capabilities.
- Provided strategic engineering and talent support for high-growth initiatives, including the HUGO expansion, and served as a trusted advisor to senior leadership on workforce planning and succession strategies.
- Recognized for exemplary cross-site collaboration, data-driven decision-making, and the ability to influence senior leaders through SLT and operations-level presentations.
Qualifications and Requirements:
Education:
- Bachelor's degree in Engineering or a related field; advanced degree preferred.
Experience:
- Minimum of 8 years of experience in manufacturing within a regulated industry, preferably medical devices.
- At least 6 years of leadership experience, including direct supervision of engineering teams.
- Comprehensive understanding of FDA, ISO, and OSHA regulations.
Skills and Competencies:
- Demonstrated leadership in sustaining engineering and continuous improvement initiatives.
- Strong communication, team-building, and conflict resolution abilities.
- Expertise in process optimization, root cause analysis, and CAPA (Corrective and Preventive Actions) execution.
- In-depth knowledge of medical device manufacturing and regulatory compliance.
- Proficiency in statistical analysis (e.g., T-tests, ANOVA), technical documentation, and validation protocols.
- Advanced proficiency in MS Office, Excel, and Minitab; Lean Six Sigma Black Belt certification preferred.
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