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Hologic, Inc. · 2 days ago
Manager, Sustaining Engineering, Capital
Newark, DE
Full-time
Onsite
Senior Level
$116K/yr - $193K/yr
8+ years exp
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Responsibilities
Lead a multi-disciplinary team focused on the maintenance of on-market products, including compliance activities, design changes/improvements, and product sustaining.
Build a high level of understanding of products and guide support, investigation, improvement, documentation, and testing of on-market products.
Accountable for root cause analysis and proper solution development for design issues, through the application of engineering principles, analysis, and empirical methods.
Build a culture of engineering excellence and continuous improvement.
Responsible for translating project objectives to define appropriate engineering personnel, schedule, scope, specifications, and resource needs.
Maintain proper prioritization of workload of team members while understanding the impact of projects to the organization and portfolio.
Responsible for communicating the purpose, direction, and strategic importance of organizational goals, setting clear expectations and team objectives, while working with leadership to improve individual and team engagement.
Provides leadership to aid in development/maintenance of project plans, and effectively deliver all work products in accordance with appropriate engineering processes and to acceptable quality standards.
Standardize policies, procedures, processes, and standards incorporating internal and industry best practices for sustaining engineering and ensuring highest quality product and efficient project execution.
Accountable for the creation, review, correction, enhancement of drawings, specifications, and documentation to meet or exceed internal and external requirements.
Maintain project documentation control and ensure that all engineering change orders, safety, functional, and third-party requirements are captured.
Accountable for identification, diagnosis, and correction of technical issues.
Implement and track solid corrective actions to reduce defects and failures.
Ensure on-time delivery of projects.
Ensure the team provides regular communication and updates on success factors such as progress, schedule, budget, project risks, and resource or needs gaps.
Establish collaborative relationships with all stakeholders within the division and create links with experts within the Hologic network and outside. Lead development of interdepartmental relationships and processes to satisfy the greater needs of Hologic.
Qualification
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Required
Experienced with FDA Quality Systems Regulation, specifically Design Control requirements, ISO 13485 and Medical Devices Directive.
Experienced with ISO 14971, Risk Management.
Knowledge of mechanical & electrical engineering principles, theories, and concepts and application for life cycle management.
In-depth knowledge of standards, regulatory and quality system requirements applicable to medical device development and manufacturing.
Ability to appropriately assess written product and project documentation as the principal advocate for compliance, and ability to effectively communicate assessment.
Knowledge in the areas of Design for Cost, Design for Reliability, Design for Serviceability and Design for Manufacture using industry standard tools and techniques.
Understanding of computer systems with a focus on CAE/CAD (Solidworks and Agile), GD&T, file transfer methods, 2D & 3D file formats and interface with other cross functional departments.
Excellent written, verbal, and interpersonal communication skills
Excellent project management skills and ability to simultaneously manage multiple projects.
High business acumen, ability to learn quickly and adapt to new circumstances, and intellectual agility.
Ability to quickly distill complex information into actions/recommendations.
Proven leadership behavior with demonstrated ability to attract and develop talent, and lead and motivate a team.
Ability to efficiently direct and coordinate the work of others.
Strong mentoring and coaching skills.
Strong communication and conflict resolution skills.
Ability to influence and communicate with all levels.
Build strong partnerships and creates followership across the organization.
Preferred
Specific knowledge in the areas of x-ray generation, imaging, and mammography is beneficial.
Experience working in a matrixed organization using Agile is beneficial.
Benefits
Comprehensive training upon joining
Continued development and training throughout the career
Competitive salary
Annual bonus scheme
Company
Hologic, Inc.
We’re an innovative medical technology company whose purpose is to enable healthier lives everywhere, every day.
5,001-10,000 employees
H1B Sponsorship
Hologic, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Trends of Total Sponsorships
2023 (9)
2022 (26)
2021 (23)
2020 (13)
Funding
Current Stage
Public CompanyTotal Funding
$450M2010-11-30Post Ipo Equity· $450M
1990-03-09IPO· nasdaq:HOLX
1988-01-01Series Unknown· Undisclosed
Leadership Team
Stephen MacMillan
Chairman, President & CEO
Karen Harrington
Director Scientific Affairs
Recent News
Medical Product Outsourcing
2024-05-27
2024-05-25
2024-05-23
Company data provided by crunchbase
