Senior Director, External Software

Abbott Laboratories; Los Angeles (CA); On-site; USD 193,000 - 387,000; Full time

Job summary

A leading medical device company in Los Angeles is seeking a Technical Leader to provide overall technical guidance and support the development of products. You will be responsible for managing R&D functions, ensuring compliance with regulations, and mentoring staff. The ideal candidate has a strong background in medical device development, leadership experience, and the ability to work in a diverse environment. The position offers a competitive salary ranging from $193,300 to $386,700.

Qualifications

• Minimum of ten years’ experience in medical device development and/or highly regulated industry.
• Previous experience leading/managing an R&D or engineering function.
• Ability to manage organizational plans and resources.

Responsibilities

• Responsible for overall technical leadership.
• Provides guidance for the design and development of company products.
• Formulates and implements research and development programs.

Skills

Leadership skills

Strong verbal and written communication

Organizational skills

Ability to work in a team

Ability to work in a diverse business environment

Time management

Education

Four-year degree in a technical field

Master’s degree in a technical or business field

Job description

What You’ll Work On

Responsible for overall technical leadership. Provides guidance for the design and development of company products. Works closely with senior management to establish product development goals while ensuring market compatibility.

Job Duties:

• Technical leader within the company.
• Formulates and implements research and development programs, policies, and procedures required to support profitable growth.
• Provides leadership to design/development teams to keep focus.
• Provides design/development teams with appropriate resources to perform assigned tasks.
• Interfaces with appropriate internal and external resources to ensure intellectual property is appropriately protected.
• Interfaces with appropriate internal and external resources (regulatory, customers, etc.) to ensure development programs meet regulatory and customer requirements.
• Obtains capital resources to meet company goals.
• Provides technical assistance for diagnosing design and manufacturing quality problems.
• Keeps senior management team informed of design/development progress and issues.
• Guides development and documentation of test plan protocols, standard operating procedures, specifications and test procedures.
• Develops departmental budget estimates.
• Contributes to business unit and divisional strategy planning.
• Participates in review boards for intellectual property, CAPA, complaints, business unit planning, and others as necessary.
• Reviews and provides functional approval for project and quality system documentation.
• Evaluates potential business partners, including physicians, vendors, contract product development and manufacturing companies.
• Develops and manages organizational plans and resources for the specific department and business units for which they are responsible.
• Provides mentorship and career development oversight for direct report employees.
• Tracks and forecasts divisional and product and technology projects
• 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
• Hires and retains a diverse, highly qualified staff and provides ongoing performance feedback. Sets goals which align to department plans and manages the execution of goals through coaching and mentoring. Maintains a safe and professional work environment.
• Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
• Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
• Performs other related duties and responsibilities, on occasion, as assigned.

Qualifications

• Four year degree in a technical field, preferably Computer Engineering or Biomedical Engineering.
• Master’s degree in a technical or business field is preferred.
• Minimum of ten (10) years’ experience in medical device development and/or other highly regulated industry.
• Previous experience leading/managing an R&D or engineering function.
• Experience working in a broader enterprise/cross division business unit model preferred.
• Experience working in a broader enterprise/cross division business unit model preferred.
• Ability to work in a highly matrixed and geographically diverse business environment.
• Strong leadership skills, including the ability to set goals and provide positive and constructive feedback respectfully to build positive relationships and improve business results.

• Ability to work effectively within a team in a fast-paced changing environment.
• Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
• Multi-tasks, prioritizes and meets deadlines in timely manner.
• Strong organizational, planning, and follow-up skills and ability to hold others accountable.

The base pay for this position is $193,300.00 – $386,700.00. In specific locations, the pay range may vary from the range posted.