Job Description

The Senior Manager of R&D is a broad and dynamic role that spans activities that range from developing long range strategies to assisting with daily execution of product development activities and programs. The role has direct management responsibilities over R&D engineering functions. This individual will play a role in technical stewardship of the company’s product innovations, working cross-functionally to keep products in a leadership position long-term.

With the R&D leadership team, the individual will be responsible for attracting and developing the top technical talent necessary to successfully execute the company’s product plan; will share in identifying and implementing innovative solutions and best practices, creating and scaling robust processes; and ultimately will develop products that meet or exceed customer requirements for quality, safety, and effectiveness and requirements for marketability. This role requires a proven track record of leading high performing teams and delivering fully developed medical products to market.

The Senior Manager will interact and collaborate with a broad set of stakeholders, including directors and executives throughout the organization, physician customers, external suppliers, OEM partners, and service providers.

Main Responsibilities:

• Responsible for hiring and retaining diverse, highly qualified staff and providing career coaching, growth, and personal development.
• Accountable for staff development: critiquing, instructing, mentoring, coaching, and evaluation. Accountable for the performance of subordinates and work output of managed subcontractors.
• Responsible for leading and fostering an innovative and ambitious culture within R&D that is consistent with company’s core values.
• Translates mission and vision into actionable, quantitative plans.
• Set expectations and objectives for direct reports and monitor progress.
• Participate in the business cycle including strategic planning, organization and talent planning, and annual operating planning.
• Collaborate on new device planning, knowledge sharing, and innovative design.
• Work not only with engineering direct reports and peers but also with partners from marketing, regulatory, clinical affairs, quality, and operations.
• Support lifecycle management of current and future products from ideation, through development, to sustaining.
• Drive innovation in all aspects of product development.
• Prepare and deliver presentations to senior management and cross-functional teams as required.
• Direct and make decisions to resolve systematic problems and to improve efficiency and speed of activities associated with medical device development.
• Apply technical expertise to diagnosing design and manufacturing quality problems.
• Coordinate with project managers to assign resources and operate within timelines and budgets.
• Comply with FDA regulations; other regulatory requirements; and company policies, operating procedures, and processes.
• Work cross-functionally to ensure proper documentation systems are implemented.
• Review and provide functional approval for project and quality system documentation.
• Ensure technical competency and expertise in the organization around risk, product safety requirements, reliability, usability requirements, and global regulatory standards and compliance.
• Remain current on developments in field of expertise, regulatory requirements, and industry trends.
• Maintain knowledge of current and novel technology through literature, trade journals, university associations, and by attending scientific conferences.
• Ability to travel 10%.

Qualifications:

Education:

• Bachelor's Degree in Mechanical Engineering, Biomedical Engineering, Chemical Engineering or related field; or an equivalent combination of education and work experience.
• Masters in technical or business field preferred.

• Minimum 4 years of demonstrated experience at a supervisory/managerial level
• Minimum 10 years:
• Strong knowledge of engineering disciplines and related disciplines.
• Progressively more responsible work experience in high technology environment.
• Experience with medical device design and product lifecycle management over multiple releases. Specifically including design and development experience in catheters (preferably balloon catheters), and electro-mechanical systems.
• Expert in current domain and knowledgeable in policies, trends, technology, and information affecting his/her industry, business, and organization.
• Understanding of global regulatory requirements for medical devices; risk and reliability concepts for development; and the need to deliver quality products and/or processes.
• A team player who is cooperative, encourages collaboration, and builds understanding. One who easily gains trust and support of superiors and peers and who can find common ground to solve problems.
• Strong leadership skills including the ability to set goals and provide constructive feedback respectfully to build positive relationships and improve business results.
• Strong verbal and written communications.
• Ability to explain complicated topics in a straight-forward and concise manner and in a style tailored to the audience.
• Ability to communicate cross-functionally and at multiple levels in the organization.
• Multi-tasks, prioritizes, and meets deadlines.
• Strong organizational, planning, and follow-up skills and ability to hold others accountable.
• Skilled at delegation and team building.
• Self-motivated to prioritize work and otherwise perform the job with minimal supervision.
• Ability to develop, monitor, and live within budgets.
• Ability to forecast major milestones.
• Has a strategic, innovative, creative and inquisitive quality of mind, with good clinical acumen and good judgment which will enable the person to provide timely and appropriately risk-balanced advice and guidance.
• Ability to influence business unit leaders with deep industry knowledge, market insights, and effective communication.
• Ability to work in a highly matrixed and geographically diverse business environment.