Posted on Apr 18, 2021 by Abbott Labs
Our business purpose is to restore health and improve quality of life through the design and provision of device and management solutions for the treatment of STRUCTURAL HEART disease. We aim to lead the markets we serve by requiring the solutions we offer customers provide an improved benefit/risk profile as compared to existing standards of care; a performance threshold that by definition, guides and ensures the productive output of our engineering, business development, and clinical research efforts result in outcomes that advance the standard of care.
WHAT YOU'LL DO
As R&D Manager, you will bring engineering leadership and best practices to lead and manage product development teams. Located at our Santa Clara, CA site, be prepared bring your knowledge and experiences to drive strong technical and program level decision making in areas such as manufacturing or processing techniques, materials, properties and engineering project planning. Additionally, in this role, you will guide direct reports to select and use techniques to solve problems and make sound design recommendations. You will also provide leadership and mentoring to other engineers and technicians. Be prepared to be a hands-on participant as necessary on the prototype line, in the test lab, and preclinically.
Engage with physician partners and other key internal and external development partners and stakeholders.
Communicate effectively both within R&D but cross-functionally as well to provide leadership in a matrixed organization.
Provide design/development teams with appropriate resources to perform assigned tasks.
Technical leader within the company.
Drive a culture of continuous improvement in development processes and tools
Formulate and implement research and development programs, policies, and procedures required to support profitable growth.
Interface with appropriate internal and external resources to ensure intellectual property is appropriately protected.
Interface with appropriate internal and external resources (regulatory, customers, etc.) to ensure development programs meet regulatory and customer requirements.
Provide technical assistance for diagnosing design and process development problems.
Keep senior management team informed of design/development progress and issues.
Guide development and documentation of test plan protocols, standard operating procedures, specifications and test procedures.
Provide input to departmental budget estimates for team headcount, materials, contractors and consultants.
Review and provide functional approval for project and quality system documentation.
Develop and manage organizational plans and resources for the specific department and business units for which they are responsible.
Provide mentorship and career development oversight for direct report employees.
Support all Divisional initiatives as identified by divisional management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements
Hire and retain a diverse, highly qualified staff and provides ongoing performance feedback. Set goals which align to department plans and manages the execution of goals through coaching and mentoring. Maintain a safe and professional work environment.
Comply with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintain positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
EXPERIENCE & EDUCATION YOU'LL BRING
Bachelor's Degree in Mechanical, Biomedical, or related engineering discipline
10+ years of experience in medical device development, including leading/managing a R&D team or a functional engineering team
Experience working in a highly matrixed and geographically diverse business environment.
Proven leadership skills, including the ability to set goals and provide positive and constructive feedback respectfully to build positive relationships and improve business results
Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
Ability to travel approximately 20%, including internationally.
Master's degree in a technical and/or business field
Experience working in a broader enterprise/cross division business unit model
Solid Understanding of ISO 13485 and CFR 820.30
Steerable catheter experience highly preferred