Manager, Sustaining Engineering, Capital

Manager, Sustaining Engineering, CapitalNewark, DE, United StatesHologic is seeking a Manager, Sustaining Engineering, Capital to join our expanding Innovation Center located in Newark, DE. This is an opportunity to support our R&D team and the healthy lives of women worldwide. Apply today !What We Expect:The Manager, Sustaining Engineering, Capital is expected direct and guide the activities of a multi-disciplinary engineering team to support the life cycle of on market capital equipment, single use devices and/or software.We expect the Manager, Sustaining Engineering, Capital Manager, Sustaining Engineering, Capital will establish a team of strong individuals who contribute to cross-functional projects as engineering experts.What To Expect:

Lead a multi-disciplinary team focused on the maintenance of on market products, including compliance activities, design changes/improvements, and product sustaining including appropriate and compliant testing.

Build a high level of understanding of our products and their use in clinical practice to guide the support, investigation, improvement, documentation and testing of our 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 project 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 aide 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 where possible the broader organization to ensure 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.

Must 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.

Ensures on time delivery of projects.

Ensures the team is providing 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.

Education

Preferred Minimum Non-Technical Degree: BA/BS Degree

Preferred Minimum Technical/Advanced Degree: Master’s Degree

Experience

Preferred Minimum Non-Technical Degree: 8+ Years

Preferred Minimum Technical/Advanced Degree: 5+ Years with Master’s Degree, 3+ Years with PhD

Experience working in a matrixed organization using Agile is beneficial.

Skills

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.

Specific knowledge in the areas of x-ray generation, imaging, and mammography is beneficial.

So why join Hologic?We are committed to making Hologic the company where top talent comes to grow. For you to succeed, we want to enable you with the tools and knowledge required and so we provide comprehensive training when you join as well as continued development and training throughout your career. We offer a competitive salary and annual bonus scheme, one of our talent partners can discuss this in more detail with you.If you have the right skills and experience and want to join our team, apply today. We can’t wait to hear from you!The annualized base salary range for this role is $116,200 -$193,200 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, geography, education, business needs and market demand.Agency and Third-Party Recruiter Notice: Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter. All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered.Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans.LI-#DS1