Director, Systems Engineering - Drug DeliveryThis position reports into the Drug Delivery Systems (DDS) group within the Operations Organization in Thousand Oaks. The successful Director of Systems Engineering will build and lead a team responsible for capturing product requirements from stakeholders, designing system architectures and interfaces, facilitating communication between functional teams, and driving development and system test practices. The Director will leverage past experience and strong communication skills to collaborate closely with marketing, regulatory, quality, and manufacturing.
Work with upper management to determine long term product, skill, and organizational needs. Assure that the products enter the field in a known and reliable state. Provide leadership for system testing, verification, validation, and risk management of medical device products. Coordinate internal and external design and test efforts.
The position requires excellent organizational, project management, technical problem solving and communication (written and verbal) skills, and the ability to work in teams and adapt to rapidly changing environment. This position should also have the following experiences:
• Stays abreast of emerging technologies, explores opportunities for implementation, and plans for integration within existing portfolio.
• Participate in system and components development process by identifying potential weak points, and develop solutions based on engineering judgment, inputs from experts, customers, suppliers and other systems partners.
• Drive engineering process in a highly regulated environment.
• Develop, procure, and use analysis tools for system analyses and modeling, and coordinate system level analyses with project and functional teams.
• Ensure information flow in a cross-functional matrix teams (internal and external), as appropriate to facilitate work flow, efficiency and quality of work results.
• Manage projects and activities in a multiple project environment with high demand schedules.
• Work with marketing, human factors, and customers to develop and evaluate new product features and user interfaces. Interface with customers to ensure customer satisfaction and address issues or observations as needed. Work with hardware engineering and system engineering to ensure design/product specification completeness and interface functionality.
• Interact/liaison between multiple departments, organizations, project teams, or other companies to document and ensure product is fully defined and traceable and people involved in product are informed.
• Identifies and establishes departmental or program objectives and implement following company policies and established procedures that are measureable such that outcomes can be quantified.
• Identifies and ensures area of responsibility complies with most current standards and monitors and prepares for pending or proposed standards.
• Generates documentation, supporting data and data analysis, reports, and presentation materials on departmental, project, or other company related activities and needs
• Prepares and gives or facilitates technical reviews and discussions, technology demonstrations, and presentations to company internal or company external organizations, teams, or individuals. Prepares and participates in briefings, technical meetings, tactical or strategic planning with other functional areas or upper management.
Basic Qualifications
• Doctorate degree & 4 years of knowledge or data management experience
OR
• Master's degree & 8 years of knowledge or data management experience
OR
• Bachelor's degree & 10 years of knowledge or data management experience
AND
• 4 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources
Preferred Qualifications
• Bachelor's degree in Engineering Management, or other Engineering/Life Sciences and 10 years of business experience, leading development organizations in multiple parallel and virtual development environments.
• MS in Engineering Management, or other Engineering/Life Sciences
• Minimum of 8+ years experience working in cross-functional roles in the development of embedded systems design, verification and validation.
• Strong background with requirements management, configurations management, defect tracking, and requirements tracing tools.
• Powerful problem-solving, risk assessment, and negotiation skills expected. Experience with complex, cross-functional projects desired.
• Experience with leading and managing development activity across multiple departments in support of enterprise wide projects.
• Proven ability to apply situational leadership concepts across various intra and inter-departmental matters.
• Strong oral/ written communication skills and interpersonal skills. Demonstrated time management, decision making, presentation and organization skills required.
• Excellent PC skills
• Previous Experience in a medical device or biotech industry.
• Background in engineering and commercialization process with injectable devices, and experience in or knowledge of processes for the production of novel formulation is also desired.
• Experience with material & test specs generation, protocol & report writing, process & test development, prototyping, design verification, DOE/SPC process optimization & validation (IQ, OQ, PQ), FMEA.
• Product design/development (design control) from concept to post product launch for Europe (EMEA/CE Mark) & US (FDA/PMA/510k) submissions.
• Industrial experience in the design and manufacturing scale-up of injectable devices (e.g. auto-injectors, pens, needle-free injectors, syringes) or devices for non-invasive or minimally invasive drug delivery systems (e.g. pulmonary, transdermal).
• Experience or knowledge in the process development of combination product aspects of these systems for macromolecules is desired.
• General knowledge of regulatory, marketing, business development and quality aspects of drug delivery device/system development is also desired.
• Experience with partnerships between pharmaceutical and drug delivery companies.
• Deep background in system engineering methodologies, particularly system specification, verification and validation strategies.
• Background in product life-cycle management from early research through development.
• Prefer experience with Requisite Pro, DOORS, Enterprise Architect (or similar), SysML/UML, Surround SCM (or similar), TestTrack, Rational ClearQuest.
• Familiarity with lean manufacturing and six-sigma methodology.
• Ability to converse technically with mechanical, electronic, software, clinical, regulatory, radio frequency, and quality engineering disciplines.
• Lead projects from development through the 510k and PMA approval process.
• Familiar with medical product development, design control process, quality and regulatory environments, and the following standards:
o US Good Manufacturing Practices - 21CFR820
o Quality Management - ISO 9001 & 13485
o Risk Management - ISO 14971
o EU Medical Device requirements - Council Directive 93/42/EEC
o Medical Electrical Equipment - EN 60601
Demonstrated Competencies/Skills:
1) Independent thinker with demonstrated skills working in teams or
leading project teams
2) Strong Interpersonal and communication skills
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