Sr Manager, R&D Sustaining Engineering

Hologic•Marlborough, MA

6h•$146,200 - $243,700•Onsite

About The Position

The Sr Manager, R&D, Sustaining Engineering leads a multi-disciplinary team to support the lifecycle management of Single Use Disposable products on the market. This role oversees all sustaining engineering activities, including ongoing compliance, design improvements, and product maintenance. The manager is accountable for team leadership, budget management, and driving organizational transformation to ensure operational excellence. This leader works on issues where analysis of situations or data requires an in-depth knowledge of organizational objectives. He/she implements strategic practices when selecting methods, techniques, and evaluation criteria for obtaining results. They are responsible to establish and assure adherence to budgets, schedules, work plans, quality and performance requirements. This individual exercises independent judgement and works on significant and unique issues where analysis of situations or data requires an evaluation of intangibles. They create formal networks involving coordination among groups.

Requirements

Bachelor’s degree in engineering or related field; Master’s degree preferred.
8+ years of experience in sustaining engineering, preferably with minimum invasive products; minimum 5+ years people management experience.
Proven track record of budget ownership and organizational transformation initiatives.
Strong knowledge of FDA regulations, ISO standards, and medical device lifecycle management.
Demonstrated leadership, mentorship, and team development capabilities.
Excellent interpersonal, and communication skills.
Experience working in matrixed organizations and driving change.
Experienced with FDA Quality Systems Regulation, specifically Design Control requirements, ISO 13485 and Medical Devices Directive.
Experienced with ISO 14971, Risk 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.
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. Builds strong partnerships and creates followership across the organization.
Must follow all applicable FDA regulations and ISO requirements.

Nice To Haves

Master’s degree preferred.

Responsibilities

Lead a multi-disciplinary team focused on the maintenance of on market products. This includes ongoing compliance activities, design changes/improvements, and product sustaining including appropriate and compliant testing.
Oversee budget planning, resource allocation, and adherence to schedules, work plans, and quality standards.
Support and functional drive organization transformation by implementing strategic practices, optimizing processes, and fostering a culture of engineering excellence and continuous improvement.
Builds 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.
Builds 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.
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.
Provides consistent, dependable guidance and mentoring to promote learning, development, and knowledge transfer.
Responsible for recruiting, leading, and developing team members. Responsibilities include interviewing, hiring, training; planning, assigning, and directing work; mentoring; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.
Lead the performance management process to provide feedback, recognize high performance, establish career planning, and provide professional development opportunities.
Grows professional and technical knowledge emphasizing on creating innovative solutions to solve problems and product improvement.
Champions opportunities for continuous improvement, investigates and then adopts processes, tools, and methodologies.