Sr. Manager, Systems Engineering

Terumo Medical Corporation (TMC) develops, manufactures, and markets a complete, solutions-based portfolio of high-quality medical devices used in a broad range of applications for numerous areas of the healthcare industry. TMC places a premium on providing customers with world-class products, training and education programs that drive clear economic value, better clinical outcomes and improved quality of life for patients. TMC is part of Tokyo-based Terumo Corporation; one of the world's leading medical device manufacturers with $6+ billion in sales, 30,000+ employees worldwide and operations in more than 160 nations. Terumo Medical Corporation is comprised of two strategic business divisions: Terumo Interventional Systems and Terumo Medical Products.

We believe that the future is bright for everyone at Terumo. We work with the future in mind to generate lasting change, create a bigger impact and produce greater outcomes for today, and for decades to come.

At Terumo we believe in the power of personal growth and will encourage you to get in the driver's seat - progressing in the direction you want to go by deepening your skills throughout your career. We want you to be bold, think outside the box, experiment, innovate and deliver what's next for quality healthcare. You will be part of a collaborative, respectful and resilient team of associates and leaders around the world, working together as partners to achieve more than you thought possible, providing real-world, impactful solutions for patients.

Join us and help shape wherever we go next!

Advancing healthcare with heart

Job Summary

The Senior Manager, Systems Engineering position is responsible for the organizational development, functional management, and performance of the PD Systems Engineering group which includes the Systems Engineering and Systems Integrator functions and PD Operations including the PD Pilot Line. The PD Pilot Line is a means by which TMC can develop pilot processes and equipment during development projects. The pilot line provides a means to generate engineering and test samples, to develop, refine, and document process procedures, and to develop and train skilled manufacturing operators for eventual transfer to Manufacturing at the end of a development project.

This position will have direct supervisory, development and performance planning responsibilities for the engineering and technician personnel within the Systems Engineering group. The Senior Manager, Systems Engineering will be accountable for the overall product performance requirements traceability via design control, clinical efficacy and usability, product testing, packaging, and design verification and validation activities needed for new product development, product transfers, and lifecycle management projects undertaken by TMC under Product Development Process & Design Controls. Additionally, the Senior Manager, Systems Engineering will be accountable for providing subject matter expertise on sustaining engineering and product continuity projects in the areas of product design, user requirements, design controls, etc. They will also be accountable for managing and guiding the Systems Integrator function on complex product development projects or for all new and legacy product line portfolios as determined by the organization.

The Senior Manager, Systems Engineering will be responsible for the management of all PD facilities located in Elkton, MD. This includes long-term strategic planning as well as day-to-day operation and maintenance of pilot line facilities and equipment, including managerial responsibility of pilot line operators, supervisors, and technicians. The Senior Manager, Systems Engineering will also serve as the PD Liaison to Medical Affairs serving to ensure the clinical understanding and efficacy of products for new product development and transfer projects. In this role, the Senior Manager, Systems Engineering shall work closely with the Director, Medical Affairs to ensure all activities are compliant with FDA guidance and expectations, as well as customer requirements and expectations.

Job Details/Responsibilities

• Responsible for the organizational development, functional management and performance of the PD Systems Engineering and Pilot Operations groups.
• Provide direct supervision, development, and performance planning to Systems Engineering Managers, Pilot Line Supervisors, Systems Engineers (including Systems Integrators), Pilot Line Operators, and any other engineering/technician personnel within the Systems Engineering group. Prepare Performance Plans, Individual Development Plans (IDPs) and conduct mid- and full year Performance Reviews with associates.
• Accountable for the overall performance requirements traceability via design control, clinical efficacy and usability, product testing, packaging, and design verification and validation activities needed for new product development, product transfers, and lifecycle management projects undertaken by TMC under Product Development Process & Design Controls.
• Lead the advancement of clinical understanding within the engineering organization. Facilitate organizational product and clinical procedure training for existing and new engineering hires; coordinate clinician interactions with the engineering organization; attend and participate in industry relevant conferences.
• Responsible for the management of all PD facilities located in Elkton, MD. Accountable for building, maintaining, and staffing pilot line capabilities overall, and as needed for specific projects. Establish and enforce best practices in pilot operations to ensure an Operations mindset early in the product/process development cycle and to simplify product transfers from development to manufacturing. Establish and enforce practices to ensure integration of engineering teams with pilot line to correctly identify Critical to Quality design and manufacturing outputs to be validated during OQ/PQ activities.
• Responsible for providing guidance and subject matter expertise on design history, design controls, user needs, clinical requirements, etc. for all matter of changes to commercial product associated with sustaining and business continuity changes across the breadth of the TIS product portfolio.
• Responsible for developing and executing long-term strategy on pilot line equipment, technology, and capability to align with overall TMC strategy.
• Responsible for oversight and management of the Systems Integrator role. Define technical objectives and coordinate with project management to ensure planning, scheduling, and resourcing (personnel, materials, time, money, suppliers) are accounted for. Provide technical leadership while identifying technical risks, challenging design decisions, and bridging the gap between the functional elements of the product development process while managing portfolio interdependencies to gain efficiency in project execution. Provide technical consultation and input to meet deliverables to support critical business and commercial objectives within product portfolios. Ensure cost viability of the new product throughout the project duration.
• Develop cost and resource estimates for project and departmental budgets. Responsible for the financial management of the aforementioned budgets throughout the year.
• Prepare presentations and formally present project updates and reviews to senior management.
• Lead special projects as assigned.
• Performs other duties as assigned.

Working Conditions/Benefits and Compensation

This position will be located in the Terumo facility located in Elkton, MD. The position will perform required duties mainly in an office environment that is co-located with the PD Laboratory and adjacent to manufacturing operations. Access to hospitals and operating rooms will be required to meet with clinicians and observe relevant clinical procedures associated with new product development activities.

We provide competitive and comprehensive benefit options that allow you to design your own plan based on your individual needs which include: paid vacation, paid holidays, health, dental and vision benefits, 401(k), with matching contributions, tax advantage savings accounts, legal plan, voluntary life and AD&D insurance, voluntary long-term disability, short term disability, critical illness and accident insurance, parental leave, personal leave, tuition reimbursement, travel assistance, and an employee assistance program. Compensation range: $148,200 - 222,400.

Knowledge, Skills and Abilities (KSA)

• Possess sufficient knowledge and experience in all technical KSAs required of the Systems Engineering team to effectively guide, coach, and manage engineering direct reports.
• Possess core leadership skills including critical thinking, judgement, listening, empathy, and communication.
• Extensive experience in the development of global Medical Devices in accordance with global regulatory and quality standards and requirements.
• Demonstrated understanding of the cross-functional interactions needed for the development of new products within FDA design control guidelines
• Demonstrated understanding of cardiology and peripheral interventional procedures and the medical devices used in those procedures.
• Demonstrated ability to effectively develop relationships and communicate with clinical Key Opinion leaders (KOLs).
• Effective communication skills, both verbal and written.
• Strong understanding of and experience with successful scale-up of processes from bench to pilot to full production, including accurate identification and treatment of critical to quality design and manufacturing specifications.
• Ability to visualize and plan multiple complex projects/activities and their impacts to existing commercial product portfolios in the short, medium, and long-term. Ability to effectively plan and communicate complex, multi-factor impacts on product portfolios.
• Ability to develop budgetary estimates and manage their execution.
• Functional management and organizational development experience in managing an Engineering group.
• Experience in preparing Performance and Development Plans and conducting Performance Reviews.

Qualifications/ Background Experiences

• BS in Engineering or other related technical field; advanced degree in Engineering or Business Administration preferred. 12+ years of experience, preferably in medical device product development or similar.
• Demonstrated experience managing a medical product new product development technical group including direct supervision, development planning, performance planning, and conducting Performance Reviews with associates.
• Demonstrated understanding of the roles and responsibilities of the cross-functional activities needed to successfully develop new and transfer existing products to manufacturing and release for commercialization.
• Demonstrated application of pre-clinical activities to include formal design validations and field visits and meetings with clinicians to facilitate the development of product requirements.

It is Terumo's policy to provide equal employment opportunity to all its employees and applicants for employment regardless of their race, creed, color, national origin, age, ancestry, nationality, marital or domestic partnership or civil union status, sex, pregnancy, gender identity or expression, disability status, liability for military service, protected veteran status, sexual orientation, atypical cellular or blood trait, genetic information (including the refusal to submit to genetic testing), or any other category protected by law. As a Company, we value diversity of background and opinion, and prohibit discrimination or harassment on the basis of any legally protected class in the areas of hiring, recruitment, promotion, transfer, demotion, training, compensation, pay, fringe benefits, layoff, termination or any other terms and conditions of employment.